HypercholesterolemiaPhase 2NCT02055976

Dose Ranging Study Of Bococizumab (PF-04950615; RN316) In Hypercholesterolemic Japanese Subjects

A Phase 2 study testing Bococizumab (PF-04950615;RN316) and Ezetimibe in people with Hypercholesterolemia, run by Pfizer at 9 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the low density lipoprotein cholesterol (LDL-C) lowering effect of Bococizumab (PF-04950615;RN316) administered subcutaneously at every two weeks (Q14D) in hypercholesterolemic Japanese subjects whose LDL-C is not controlled by a stable dose of atorvastatin, or who are naïve to… Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Hypercholesterolemia
What is being tested?: Bococizumab (PF-04950615;RN316) and Ezetimibe
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 218 participants
Where: 9 sitesJapan
Study dates: Mar 2014to Jan 2015
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects whose LDL-C is not controlled by a stable dose of atorvastatin (Population A).
Subjects who are naïve to a treatment by lipid lowering drug and whose LDL-C is not controlled (Population B).

Who cannot join

Severe acute or chronic medical or psychiatric condition or laboratory abnormality.
Pregnant females; breastfeeding females; males and females of childbearing potential; males and females of childbearing potential who are unwilling or unable to use a highly effective method of contraception.
Subjects who were administered or prior exposed to PF-04950615 and/or anti-body targeting PCSK9.

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

Japan9 sites

Meiwa Hospital
Chiyoda-ku, Tokyo, 101-0041
Tokyo-Eki Center-building Clinic
Chuo-ku, Tokyo, 103-0027
Maebashi Hirosegawa Clinic
Maebashi, Gunma, 371-0022
Heishinkai Medical Group Incorporated ToCROM Clinic
Shinjuku-ku, Tokyo, 160-0022
Clinical Research Hospital Tokyo
Shinjuku-ku, Tokyo, 162-0053
Oda Clinic
Shinjuku-ku, Tokyo, 169-0072
Heishinkai Medical Group Incorporated OCROM Clinic
Suita, Osaka, 565-0853
Sekino Hospital
Toshima-ku, Tokyo, 171-0014
Yokohama Minoru Clinic
Yokohama, Kanagawa, 232-0064

Other trials in Japan

About this study

Official title: A Phase 2 Double Blind, Parallel Group, Placebo Controlled, Randomized, Dose Ranging Study To Assess The Efficacy, Safety And Tolerability Of Pf-04950615 Following Twice Monthly Subcutaneous Doses In Hypercholesterolemic Japanese Subjects Who Are Receiving A Stable Dose Of Atorvastatin Or Treatment Naïve.

Conditions: Hypercholesterolemia
Being tested: Bococizumab (PF-04950615;RN316), Placebo, Ezetimibe
Keywords: PF-04950615, Japan
Medical subject headings: Hypercholesterolemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bococizumab (PF-04950615;RN316)Drug
Atorvastatin plus PF-04950615 50 mg subcutaneous administration at every two weeks (Q14D SC) for 16 week
Bococizumab (PF-04950615;RN316)Drug
Atorvastatin plus PF-04950615 100 mg Q14D SC for 16 week
Bococizumab (PF-04950615;RN316)Drug
Atorvastatin plus PF-04950615 150 mg Q14D SC for 16 week
PlaceboDrug
Atorvastatin plus PF-04950615 Placebo Q14D SC for 16 week
EzetimibeDrug
Atorvastatin plus Ezetimibe 10 mg oral administration once daily for 16 week (open)
Bococizumab (PF-04950615;RN316)Drug
50 mg Q14D SC for 16 week
Bococizumab (PF-04950615;RN316)Drug
100 mg Q14D SC for 16 week
Bococizumab (PF-04950615;RN316)Drug
150 mg Q14D SC for 16 week
PlaceboDrug
Placebo Q14D SC for 16 week

Study groups in NCT02055976
Study group	Role	What they receive
Population A	Experimental	A total of 9 groups in two population. Population A comprises hypercholesterolemic Japanese subjects whose LDL-C is not controlled by a stable dose of atorvastatin. A subject who is receiving a stable dose of atorvastatin will be randomized into one out of 5 dose groups. Receives: Drug: Bococizumab (PF-04950615;RN316); Drug: Placebo; Drug: Ezetimibe
Population B	Experimental	A total of 9 groups in two population. Population B comprises hypercholesterolemic Japanese subjects who are naïve for a treatment by lipid lowering drug and whose fasting LDL-cholesterol is not controlled. A subject who is treatment naïve will be randomized into one out of 4 dose groups. Receives: Drug: Bococizumab (PF-04950615;RN316); Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 85
LDL-C is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.
Measured: Baseline, Day 85
Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 113
LDL-C is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.
Measured: Baseline, Day 113

Secondary outcomes (46)

Low Density Lipoprotein-Cholesterol (LDL-C)
LDL-C is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Measured: Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169
Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Day 85 and Day 113
LDL-C is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Measured: Baseline, Day 85, 113
Total Cholesterol (TC)
Total cholesterol is the sum of all the cholesterol within the blood. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Measured: Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169
Change From Baseline in Total Cholesterol (TC) at Day 85 and Day 113
Total cholesterol is the sum of all the cholesterol within the blood. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Measured: Baseline, Day 85, 113
Percent Change From Baseline in Total Cholesterol (TC) at Day 85 and Day 113
Total cholesterol is the sum of all the cholesterol within the blood. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.
Measured: Baseline, Day 85, 113
Apolipoprotein B (ApoB)
ApoB is a major protein that makes up LDL cholesterol and is involved in transporting cholesterol and triglycerides to cells and tissues in the body. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Measured: Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169
Change From Baseline in Apolipoprotein B (ApoB) at Day 85 and Day 113
ApoB is a major protein that makes up LDL cholesterol and is involved in transporting cholesterol and triglycerides to cells and tissues in the body. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Measured: Baseline, Day 85, 113
Percent Change From Baseline in Apolipoprotein B (ApoB) at Day 85 and Day 113
ApoB is a major protein that makes up LDL cholesterol and is involved in transporting cholesterol and triglycerides to cells and tissues in the body. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.
Measured: Baseline, Day 85, 113
Apolipoprotein A-I (ApoA-I)
ApoA1 is a major protein that is a component of HDL cholesterol and helps in clearing cholesterol from the blood by removing cholesterol from organs and tissues to be destroyed by the liver. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Measured: Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169
Change From Baseline in Apolipoprotein A-I (ApoA-I) at Day 85 and Day 113
ApoA1 is a major protein that is a component of HDL cholesterol and helps in clearing cholesterol from the blood by removing cholesterol from organs and tissues to be destroyed by the liver. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Measured: Baseline, Day 85, 113
Percent Change From Baseline in Apolipoprotein A-I (ApoA-I) at Day 85 and Day 113
ApoA1 is a major protein that is a component of HDL cholesterol and helps in clearing cholesterol from the blood by removing cholesterol from organs and tissues to be destroyed by the liver. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.
Measured: Baseline, Day 85, 113
Apolipoprotein A-II (ApoA-II)
ApoA-II is the second most abundant component of the HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Measured: Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169
Change From Baseline in Apolipoprotein A-II (ApoA-II) at Day 85 and Day 113
ApoA-II is the second most abundant component of the HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Measured: Baseline, Day 85, 113
Percent Change From Baseline in Apolipoprotein A-II (ApoA-II) at Day 85 and Day 113
ApoA-II is the second most abundant component of the HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.
Measured: Baseline, Day 85, 113
Lipoprotein (a) (Lp[a])
Lp(a) is a lipoprotein subclass which consists of an LDL-like particle and the specific apolipoprotein(a). Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Measured: Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169
Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 85 and Day 113
Lp(a) is a lipoprotein subclass which consists of an LDL-like particle and the specific apolipoprotein(a). Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Measured: Baseline, Day 85, 113
Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 85 and Day 113
Lp(a) is a lipoprotein subclass which consists of an LDL-like particle and the specific apolipoprotein(a). Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.
Measured: Baseline, Day 85, 113
High Density Lipoprotein- Cholesterol (HDL-C)
HDL-C is cholesterol in the bloodstream that is carried by high density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Measured: Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169
Change From Baseline in High Density Lipoprotein- Cholesterol (HDL-C) at Day 85 and Day 113
HDL-C is cholesterol in the bloodstream that is carried by high density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Measured: Baseline, Day 85, 113
Percent Change From Baseline in High Density Lipoprotein- Cholesterol (HDL-C) at Day 85 and Day 113
HDL-C is cholesterol in the bloodstream that is carried by high density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.
Measured: Baseline, Day 85, 113
Very Low Density Lipoprotein-Cholesterol (VLDL-C)
VLDL is a type of lipoprotein made by the liver and one of the five major groups of lipoproteins, that enable fats and cholesterol to move within the water-based solution of the bloodstream. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Measured: Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169
Change From Baseline in Very Low Density Lipoprotein-Cholesterol (VLDL-C) at Day 85 and Day 113
VLDL is a type of lipoprotein made by the liver and one of the five major groups of lipoproteins, that enable fats and cholesterol to move within the water-based solution of the bloodstream. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Measured: Baseline, Day 85, 113
Percent Change From Baseline in Very Low Density Lipoprotein-Cholesterol (VLDL-C) at Day 85 and Day 113
VLDL is a type of lipoprotein made by the liver and one of the five major groups of lipoproteins, that enable fats and cholesterol to move within the water-based solution of the bloodstream. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.
Measured: Baseline, Day 85, 113
Triglyceride (TG)
Triglycerides are a type of fat circulating in the blood and account for the majority of the fats circulating in the blood. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Measured: Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169
Change From Baseline in Triglyceride (TG) at Day 85 and Day 113
Triglycerides are a type of fat circulating in the blood and account for the majority of the fats circulating in the blood. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Measured: Baseline, Day 85, 113
Percent Change From Baseline in Triglyceride (TG) at Day 85 and Day 113
Triglycerides are a type of fat circulating in the blood and account for the majority of the fats circulating in the blood. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.
Measured: Baseline, Day 85, 113
Non-High Density Lipoprotein- Cholesterol (Non-HDL-C)
Non-HDL-C calculated as total cholesterol minus HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Measured: Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169
Change From Baseline in Non-High Density Lipoprotein- Cholesterol (Non-HDL-C) at Day 85 and Day 113
Non-HDL-C calculated as total cholesterol minus HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Measured: Baseline, Day 85, 113
Percent Change From Baseline in Non-High Density Lipoprotein- Cholesterol (Non-HDL-C) at Day 85 and Day 113
Non-HDL-C calculated as total cholesterol minus HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.
Measured: Baseline, Day 85, 113
Total Cholesterol (TC) / High Density Lipoprotein- Cholesterol (HDL-C) Ratio
Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Measured: Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169
Change From Baseline in Total Cholesterol (TC) / High Density Lipoprotein- Cholesterol (HDL-C) Ratio at Day 85 and Day 113
Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Measured: Baseline, Day 85, 113
Percent Change From Baseline in Total Cholesterol (TC) / High Density Lipoprotein- Cholesterol (HDL-C) Ratio at Day 85 and Day 113
Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.
Measured: Baseline, Day 85, 113
Apolipoprotein B (ApoB) / Apolipoprotein A-I (ApoA-I) Ratio
Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.
Measured: Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169
Change From Baseline in Apolipoprotein B (ApoB) / Apolipoprotein A-I (ApoA-I) Ratio at Day 85 and Day 113
Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.
Measured: Baseline, Day 85, 113
Percent Change From Baseline in Apolipoprotein B (ApoB) / Apolipoprotein A-I (ApoA-I) Ratio at Day 85 and Day 113
Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.
Measured: Baseline, Day 85, 113
Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 10, 25, 40, 70 and 100 Milligram Per Deciliter
LDL-C is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection.
Measured: Baseline up to Day 113
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs)
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are events between first dose of study drug and up to Day 169 that were absent before treatment or that worsened relative to pretreatment state. Adverse events included treatment emergent injection site adverse events and any clinically significant abnormal laboratory value.
Measured: Baseline up to Day 169
Number of Participants With Anti-Drug Antibody (ADA) Response
Participants tested positive for ADA response on at least one post-baseline visit were reported. Participants with ADA titer level >=6.23 for PF-04950615 were considered ADA positive.
Measured: Baseline up to Day 169
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-04950615
Area under the plasma concentration time-curve from time zero to end of dosing interval (tau). This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615.
Measured: Single dose (Day 1: pre-dose, 24, 48, 72, 96, 120, 144, 168 hour (hr) post-dose), Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose)
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of PF-04950615
Area under the plasma concentration-time profile from time zero extrapolated to infinite time. This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615.
Measured: Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-04950615
Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration. This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615.
Measured: Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose)
Maximum Observed Plasma Concentration (Cmax) of PF-04950615
This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615.
Measured: Single dose (Day 1: pre-dose, 24, 48, 72, 96, 120, 144, 168 hr post-dose), Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose)
Minimum Observed Plasma Trough Concentration (Cmin) of PF-04950615
This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615.
Measured: Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose)
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04950615
This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615.
Measured: Single dose (Day 1: pre-dose, 24, 48, 72, 96, 120, 144, 168 hour (hr) post-dose), Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose)
Terminal Elimination Half-Life (t1/2) of PF-04950615
Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half. This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615.
Measured: Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose)
Plasma Concentration of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)
Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLQ =6.99 nanogram per milliliter [ng/mL]) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) =0. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.
Measured: Day 1, 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2014Jan 2015

First posted5 Feb 2014 (estimated)
Study startMar 2014
Primary completionJan 2015
Study completionJan 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 218 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02055976
Sponsor's protocol ID: B1481036
Status last verified: Sep 2018
First submitted: 22 Jan 2014
Last updated: 8 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Wang EQ, Kaila N, Plowchalk D, Gibiansky L, Yunis C, Sweeney K. Population PK/PD modeling of low-density lipoprotein cholesterol response in hypercholesterolemic participants following administration of bococizumab, a potent anti-PCSK9 monoclonal antibody. CPT Pharmacometrics Syst Pharmacol. 2023 Dec;12(12):2013-2026. doi: 10.1002/psp4.13050. Epub 2023 Nov 22.
PubMed 37994400
Yokote K, Suzuki A, Li Y, Matsuoka N, Teramoto T. Pharmacokinetics and exploratory efficacy biomarkers of bococizumab, an anti-PCSK9 monoclonal antibody, in hypercholesterolemic Japanese subjects . Int J Clin Pharmacol Ther. 2019 Dec;57(12):575-589. doi: 10.5414/CP203418.
PubMed 31549625
Yokote K, Kanada S, Matsuoka O, Sekino H, Imai K, Tabira J, Matsuoka N, Chaudhuri S, Teramoto T. Efficacy and Safety of Bococizumab (RN316/PF-04950615), a Monoclonal Antibody Against Proprotein Convertase Subtilisin/Kexin Type 9, in Hypercholesterolemic Japanese Subjects Receiving a Stable Dose of Atorvastatin or Treatment-Naive - Results From a Randomized, Placebo-Controlled, Dose-Ranging Study. Circ J. 2017 Sep 25;81(10):1496-1505. doi: 10.1253/circj.CJ-16-1310. Epub 2017 May 23.
PubMed 28539539

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia

All Hypercholesterolemia trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2 Double Blind, Parallel Group, Placebo Controlled, Randomized, Dose Ranging Study To Assess The Efficacy, Safety And Tolerability Of Pf-04950615 Following Twice Monthly Subcutaneous Doses In Hypercholesterolemic Japanese Subjects Who Are Receiving A Stable Dose Of Atorvastatin Or Treatment Naïve.
ClinicalTrials.gov ID: NCT02055976
Acronym / sponsor ID: B1481036
Conditions: Hypercholesterolemia
Keywords: PF-04950615, Japan
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 218 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Mar 2014 (actual)
Primary completion: Jan 2015 (actual)
Study completion: Jan 2015 (actual)
First posted: 5 Feb 2014 (estimated)
Results: Posted 8 Feb 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Population A	Experimental	Drug: Bococizumab (PF-04950615;RN316), Drug: Placebo, Drug: EzetimibeA total of 9 groups in two population. Population A comprises hypercholesterolemic Japanese subjects whose LDL-C is not controlled by a stable dose of atorvastatin. A subject who is receiving a stable dose of atorvastatin will be randomized into one out of 5 dose groups.
Population B	Experimental	Drug: Bococizumab (PF-04950615;RN316), Drug: PlaceboA total of 9 groups in two population. Population B comprises hypercholesterolemic Japanese subjects who are naïve for a treatment by lipid lowering drug and whose fasting LDL-cholesterol is not controlled. A subject who is treatment naïve will be randomized into one out of 4 dose groups.

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Subjects whose LDL-C is not controlled by a stable dose of atorvastatin (Population A).
Subjects who are naïve to a treatment by lipid lowering drug and whose LDL-C is not controlled (Population B).

Key exclusion criteria (3 listed)

Severe acute or chronic medical or psychiatric condition or laboratory abnormality.
Pregnant females; breastfeeding females; males and females of childbearing potential; males and females of childbearing potential who are unwilling or unable to use a highly effective method of contraception.
Subjects who were administered or prior exposed to PF-04950615 and/or anti-body targeting PCSK9.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Bococizumab (PF-04950615;RN316)Atorvastatin plus PF-04950615 50 mg subcutaneous administration at every two weeks (Q14D SC) for 16 week	Drug	Population A
Bococizumab (PF-04950615;RN316)Atorvastatin plus PF-04950615 100 mg Q14D SC for 16 week	Drug	Population A
Bococizumab (PF-04950615;RN316)Atorvastatin plus PF-04950615 150 mg Q14D SC for 16 week	Drug	Population A
PlaceboAtorvastatin plus PF-04950615 Placebo Q14D SC for 16 week	Drug	Population A
EzetimibeAtorvastatin plus Ezetimibe 10 mg oral administration once daily for 16 week (open)	Drug	Population A
Bococizumab (PF-04950615;RN316)50 mg Q14D SC for 16 week	Drug	Population B
Bococizumab (PF-04950615;RN316)100 mg Q14D SC for 16 week	Drug	Population B
Bococizumab (PF-04950615;RN316)150 mg Q14D SC for 16 week	Drug	Population B
PlaceboPlacebo Q14D SC for 16 week	Drug	Population B

Primary outcome

Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 85
Time frame: Baseline, Day 85
LDL-C is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.
Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 113
Time frame: Baseline, Day 113
LDL-C is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.

46 secondary outcomes

Low Density Lipoprotein-Cholesterol (LDL-C)
Time frame: Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169
Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Day 85 and Day 113
Time frame: Baseline, Day 85, 113
Total Cholesterol (TC)
Time frame: Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169
Change From Baseline in Total Cholesterol (TC) at Day 85 and Day 113
Time frame: Baseline, Day 85, 113
Percent Change From Baseline in Total Cholesterol (TC) at Day 85 and Day 113
Time frame: Baseline, Day 85, 113
Apolipoprotein B (ApoB)
Time frame: Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169
Change From Baseline in Apolipoprotein B (ApoB) at Day 85 and Day 113
Time frame: Baseline, Day 85, 113
Percent Change From Baseline in Apolipoprotein B (ApoB) at Day 85 and Day 113
Time frame: Baseline, Day 85, 113
Apolipoprotein A-I (ApoA-I)
Time frame: Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169
Change From Baseline in Apolipoprotein A-I (ApoA-I) at Day 85 and Day 113
Time frame: Baseline, Day 85, 113
Percent Change From Baseline in Apolipoprotein A-I (ApoA-I) at Day 85 and Day 113
Time frame: Baseline, Day 85, 113
Apolipoprotein A-II (ApoA-II)
Time frame: Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169
Change From Baseline in Apolipoprotein A-II (ApoA-II) at Day 85 and Day 113
Time frame: Baseline, Day 85, 113
Percent Change From Baseline in Apolipoprotein A-II (ApoA-II) at Day 85 and Day 113
Time frame: Baseline, Day 85, 113
Lipoprotein (a) (Lp[a])
Time frame: Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169
Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 85 and Day 113
Time frame: Baseline, Day 85, 113
Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 85 and Day 113
Time frame: Baseline, Day 85, 113
High Density Lipoprotein- Cholesterol (HDL-C)
Time frame: Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169
Change From Baseline in High Density Lipoprotein- Cholesterol (HDL-C) at Day 85 and Day 113
Time frame: Baseline, Day 85, 113
Percent Change From Baseline in High Density Lipoprotein- Cholesterol (HDL-C) at Day 85 and Day 113
Time frame: Baseline, Day 85, 113
Very Low Density Lipoprotein-Cholesterol (VLDL-C)
Time frame: Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169
Change From Baseline in Very Low Density Lipoprotein-Cholesterol (VLDL-C) at Day 85 and Day 113
Time frame: Baseline, Day 85, 113
Percent Change From Baseline in Very Low Density Lipoprotein-Cholesterol (VLDL-C) at Day 85 and Day 113
Time frame: Baseline, Day 85, 113
Triglyceride (TG)
Time frame: Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169
Change From Baseline in Triglyceride (TG) at Day 85 and Day 113
Time frame: Baseline, Day 85, 113
Percent Change From Baseline in Triglyceride (TG) at Day 85 and Day 113
Time frame: Baseline, Day 85, 113
Non-High Density Lipoprotein- Cholesterol (Non-HDL-C)
Time frame: Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169
Change From Baseline in Non-High Density Lipoprotein- Cholesterol (Non-HDL-C) at Day 85 and Day 113
Time frame: Baseline, Day 85, 113
Percent Change From Baseline in Non-High Density Lipoprotein- Cholesterol (Non-HDL-C) at Day 85 and Day 113
Time frame: Baseline, Day 85, 113
Total Cholesterol (TC) / High Density Lipoprotein- Cholesterol (HDL-C) Ratio
Time frame: Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169
Change From Baseline in Total Cholesterol (TC) / High Density Lipoprotein- Cholesterol (HDL-C) Ratio at Day 85 and Day 113
Time frame: Baseline, Day 85, 113
Percent Change From Baseline in Total Cholesterol (TC) / High Density Lipoprotein- Cholesterol (HDL-C) Ratio at Day 85 and Day 113
Time frame: Baseline, Day 85, 113
Apolipoprotein B (ApoB) / Apolipoprotein A-I (ApoA-I) Ratio
Time frame: Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169
Change From Baseline in Apolipoprotein B (ApoB) / Apolipoprotein A-I (ApoA-I) Ratio at Day 85 and Day 113
Time frame: Baseline, Day 85, 113
Percent Change From Baseline in Apolipoprotein B (ApoB) / Apolipoprotein A-I (ApoA-I) Ratio at Day 85 and Day 113
Time frame: Baseline, Day 85, 113
Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 10, 25, 40, 70 and 100 Milligram Per Deciliter
Time frame: Baseline up to Day 113
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs)
Time frame: Baseline up to Day 169
Number of Participants With Anti-Drug Antibody (ADA) Response
Time frame: Baseline up to Day 169
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-04950615
Time frame: Single dose (Day 1: pre-dose, 24, 48, 72, 96, 120, 144, 168 hour (hr) post-dose), Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose)
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of PF-04950615
Time frame: Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose)

Results and safety

Results posted to the registry on 8 Feb 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Atorvastatin + PF-04950615 50 mg	25	25
Atorvastatin + PF-04950615 100 mg	24	24
Atorvastatin + PF-04950615 150 mg	24	23
Atorvastatin + PF-04950615 Placebo	26	25
Atorvastatin + Ezetimibe 10 mg	22	22
PF-04950615 50 mg	25	24
PF-04950615 100 mg	25	23
PF-04950615 150 mg	24	24
PF-04950615 Placebo	23	23

Primary outcome: Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 85

Time frame: Baseline, Day 85. Mean (Standard Deviation). Unit: percent change

Measure	Atorvastatin + PF-04950615 50 mg n = 25	Atorvastatin + PF-04950615 100 mg n = 24	Atorvastatin + PF-04950615 150 mg n = 23	Atorvastatin + PF-04950615 Placebo n = 26	Atorvastatin + Ezetimibe 10 mg n = 22	PF-04950615 50 mg n = 25	PF-04950615 100 mg n = 23	PF-04950615 150 mg n = 24	PF-04950615 Placebo n = 23
Value	-55.65 (15.748)	-68.25 (18.769)	-74.00 (13.848)	-5.91 (14.323)	-18.56 (15.968)	-47.25 (17.699)	-62.24 (16.097)	-65.89 (10.779)	-1.21 (14.815)

Atorvastatin + PF-04950615 50 mg vs Atorvastatin + PF-04950615 Placebo: Adjusted Mean Difference: -49.838 (95% CI -57.335 to -42.340), p <0.001, Mixed Models Analysis
Atorvastatin + PF-04950615 100 mg vs Atorvastatin + PF-04950615 Placebo: Adjusted Mean Difference: -66.754 (95% CI -74.523 to -58.986), p <0.001, Mixed Models Analysis
Atorvastatin + PF-04950615 150 mg vs Atorvastatin + PF-04950615 Placebo: Adjusted Mean Difference: -71.534 (95% CI -79.284 to -63.784), p <0.001, Mixed Models Analysis

Population analysed: Full analysis set (FAS) included all the participants who were randomized and administered at least 1 dose of study treatment.

Primary outcome: Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 113

Time frame: Baseline, Day 113. Mean (Standard Deviation). Unit: percent change

Measure	Atorvastatin + PF-04950615 50 mg n = 24	Atorvastatin + PF-04950615 100 mg n = 24	Atorvastatin + PF-04950615 150 mg n = 23	Atorvastatin + PF-04950615 Placebo n = 25	Atorvastatin + Ezetimibe 10 mg n = 22	PF-04950615 50 mg n = 25	PF-04950615 100 mg n = 23	PF-04950615 150 mg n = 23	PF-04950615 Placebo n = 23
Value	-54.41 (12.062)	-64.46 (19.149)	-69.98 (19.074)	-12.10 (12.727)	-20.55 (18.682)	-44.94 (19.641)	-61.79 (15.476)	-66.98 (12.396)	0.39 (16.246)

Atorvastatin + PF-04950615 50 mg vs Atorvastatin + PF-04950615 Placebo: Adjusted Mean Difference: -42.293 (95% CI -49.417 to -35.168), p <0.001, Mixed Models Analysis
Atorvastatin + PF-04950615 100 mg vs Atorvastatin + PF-04950615 Placebo: Adjusted Mean Difference: -56.262 (95% CI -63.603 to -48.921), p <0.001, Mixed Models Analysis
Atorvastatin + PF-04950615 150 mg vs Atorvastatin + PF-04950615 Placebo: Adjusted Mean Difference: -61.384 (95% CI -68.733 to -54.035), p <0.001, Mixed Models Analysis

Population analysed: FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, number of participants analyzed (N) signifies number of participants evaluable for this outcome measure.

46 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Atorvastatin + PF-04950615 50 mg	1 of 25 (4%)	10 of 25 (40%)	Not reported
Atorvastatin + PF-04950615 100 mg	0 of 24 (0%)	12 of 24 (50%)	Not reported
Atorvastatin + PF-04950615 150 mg	0 of 24 (0%)	12 of 24 (50%)	Not reported
Atorvastatin + PF-04950615 Placebo	1 of 26 (3.8%)	10 of 26 (38.5%)	Not reported
Atorvastatin + Ezetimibe 10 mg QD PO	0 of 22 (0%)	2 of 22 (9.1%)	Not reported
PF-04950615 50 mg	0 of 25 (0%)	11 of 25 (44%)	Not reported
PF-04950615 100 mg	1 of 25 (4%)	11 of 25 (44%)	Not reported
PF-04950615 150 mg	0 of 24 (0%)	11 of 24 (45.8%)	Not reported
PF-04950615 Placebo	0 of 23 (0%)	9 of 23 (39.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37994400Wang EQ, Kaila N, Plowchalk D, Gibiansky L, Yunis C, Sweeney K. Population PK/PD modeling of low-density lipoprotein cholesterol response in hypercholesterolemic participants following administration of bococizumab, a potent anti-PCSK9 monoclonal antibody. CPT Pharmacometrics Syst Pharmacol. 2023 Dec;12(12):2013-2026. doi: 10.1002/psp4.13050. Epub 2023 Nov 22.
Derived from this study: PubMed 31549625Yokote K, Suzuki A, Li Y, Matsuoka N, Teramoto T. Pharmacokinetics and exploratory efficacy biomarkers of bococizumab, an anti-PCSK9 monoclonal antibody, in hypercholesterolemic Japanese subjects . Int J Clin Pharmacol Ther. 2019 Dec;57(12):575-589. doi: 10.5414/CP203418.
Derived from this study: PubMed 28539539Yokote K, Kanada S, Matsuoka O, Sekino H, Imai K, Tabira J, Matsuoka N, Chaudhuri S, Teramoto T. Efficacy and Safety of Bococizumab (RN316/PF-04950615), a Monoclonal Antibody Against Proprotein Convertase Subtilisin/Kexin Type 9, in Hypercholesterolemic Japanese Subjects Receiving a Stable Dose of Atorvastatin or Treatment-Naive - Results From a Randomized, Placebo-Controlled, Dose-Ranging Study. Circ J. 2017 Sep 25;81(10):1496-1505. doi: 10.1253/circj.CJ-16-1310. Epub 2017 May 23.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bococizumab (PF-04950615;RN316) and Ezetimibe in people with Hypercholesterolemia, run by Pfizer at 9 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 85 (time frame: Baseline, Day 85). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02055976, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2019.