Heterozygous Familial HypercholesterolemiaPhase 4NCT03694197

Long Term Safety Study of PRALUENT

A Phase 4 study testing Praluent in people with Heterozygous Familial Hypercholesterolemia and Non-familial Hypercholesterolemia, run by Regeneron Pharmaceuticals at 123 sites in 6 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

The primary objective of the study was to evaluate the long term safety of PRALUENT in participants with heterozygous familial hypercholesterolemia (heFH) or non-familial hypercholesterolemia (FH) participants at high or very high cardiovascular risk who completed the neurocognitive function study R727-CL-1532… Read more about this study

Who is it for?: Ages 40 to 85 years
Conditions the study is for: Heterozygous Familial Hypercholesterolemia, Non-familial Hypercholesterolemia
What is being tested?: Praluent
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,389 participants
Where: 123 sitesin 6 countries
Study dates: 28 Sep 2018to 8 Apr 2020
Phase: Phase 4
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 40 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participants randomized into the neurocognitive function study (R727-CL-1532) who completed treatment and the end of study (EOS) visit with no premature or permanent discontinuation of study drug.

Who cannot join

Significant protocol deviation in the parent study (neurocognitive function study R727-CL-1532: NCT02957682) based on the investigator's or sponsor's judgment, such as noncompliance
Any participant who experienced an AE leading to permanent discontinuation from the neurocognitive function study R727-CL-1532 (NCT02957682).
Any new condition or worsening of an existing condition which, in the opinion of the investigator or per the PRALUENT local label, would make the participant unsuitable for enrollment or could interfere with the participant participating in or completing the open-label extension (OLE) study
Known hypersensitivity to monoclonal antibody or any component of the drug product
Pregnant or breastfeeding women
Note: Other inclusion/ exclusion criteria apply

Trial locations and contacts

123 sites in 6 countries.

Country

City, postcode or hospital

123 sites in 6 countries

United States57 sites

Regeneron Research Site
Ames, Iowa, 50010-30144
Regeneron Research Site
Auburn, Alabama, 36830
Regeneron Research Site
Aurora, Colorado, 80012
Regeneron Research Site
Baltimore, Maryland, 21229
Regeneron Research Site
Bangor, Maine, 04401
Regeneron Research Site
Beverly Hills, California, 90210
Regeneron Research Site
Bristol, Tennessee, 37620
Regeneron Research Site
Buffalo, New York, 14215
Regeneron Research Site
Cary, North Carolina, 27518
Regeneron Research Site
Champaign, Illinois, 61822
Regeneron Research Site
Charleston, South Carolina, 29407
Regeneron Research Site
Charlotte, North Carolina, 28209
Regeneron Research Site
Charlotte, North Carolina, 28277
Regeneron Research Site
Cincinnati, Ohio, 45219
Regeneron Research Site
Cleveland, Ohio, 44122
Regeneron Research Site
Colorado Springs, Colorado, 80906
Regeneron Research Site
Dallas, Texas, 75231
Regeneron Research Site
Dayton, Ohio, 45414
Regeneron Research Site
Evansville, Indiana, 47714
Regeneron Research Site
Falls Church, Virginia, 22042
Regeneron Research Site
Greensboro, North Carolina, 27401
Regeneron Research Site
Hickory, North Carolina, 28601
Regeneron Research Site
Houston, Texas, 77027
Regeneron Research Site
Indianapolis, Indiana, 46237
Regeneron Research Site
Iowa City, Iowa, 52242
Regeneron Research Site 2
Knoxville, Tennessee, 37760
Regeneron Research Site 3
Knoxville, Tennessee, 37912
Regeneron Research Site
Knoxville, Tennessee, 37938
Regeneron Research Site
Lake Worth, Florida, 33461
Regeneron Research Site
Los Gatos, California, 95032
Regeneron Research Site
Louisville, Kentucky, 40213
Regeneron Research Site
Manitowoc, Wisconsin, 54220
Regeneron Research Site
Miami Springs, Florida, 33166
Regeneron Research Site
Mobile, Alabama, 36608
Regeneron Research Site
New Hyde Park, New York, 11042
Regeneron Research Site
Newton, Kansas, 67114
Regeneron Research Site
North Hollywood, California, 91606
Regeneron Research Site
Olive Branch, Mississippi, 38654
Regeneron Research Site
Oxon Hill, Maryland, 20745
Regeneron Research Site
Port Hueneme, California, 93041
Regeneron Research Site
Powell, Tennessee, 37849
Regeneron Research Site
Raleigh, North Carolina, 27609
Regeneron Research Site
Rapid City, South Dakota, 57701
Regeneron Research Site
Rocky Mount, North Carolina, 27804
Regeneron Research Site
Salisbury, North Carolina, 28144
Regeneron Research Site
Schertz, Texas, 78154
Regeneron Research Site
Shavano Park, Texas, 78213
Regeneron Research Site
Shavano Park, Texas, 78231
Regeneron Research Site
Statesville, North Carolina, 28625
Regeneron Research Site
Summerville, South Carolina, 29485
Regeneron Research Site
Tacoma, Washington, 98405
Regeneron Research Site
Walla Walla, Washington, 99362
Regeneron Research Site
Washington, Missouri, 63090
Regeneron Research Site
Waterloo, Iowa, 50702
Regeneron Research Site
Wilmington, North Carolina, 28401
Regeneron Research Site
Winchester, Virginia, 22601
Regeneron Research Site
Winston-Salem, North Carolina, 27103

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Russia20 sites

Regeneron Research Site
Ivanovo, 153012
Regeneron Research Site
Kirov, 610014
Regeneron Research Site
Moscow, 121309
Regeneron Research Site
Moscow, 121359
Regeneron Research Site
Moscow, 121552
Regeneron Research Site
Novosibirsk, 630008
Regeneron Research Site
Rostov-on-Don, 344068
Regeneron Research Site #2
Saint Petersburg, 192288
Regeneron Research Site
Saint Petersburg, 192288
Regeneron Research Site
Saint Petersburg, 193312
Regeneron Research Site
Saint Petersburg, 195112
Regeneron Research Site
Saint Petersburg, 197376
Regeneron Research Site
Saint Petersburg, 197706
Regeneron Research Site
Saint Petersburg, 198205
Regeneron Research Site
Saratov, 410028
Regeneron Research Site
Sverdlovskaya, 620109
Regeneron Research Site
Tyumen, 625032
Regeneron Research Site 1
Yaroslavl, 150030
Regeneron Research Site 2
Yaroslavl, 150030
Regeneron Research Site
Yekaterinburg, 620109

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South Africa19 sites

Regeneron Research Site
Bloemfontein, 9301
Regeneron Research Site
Cape Town, Western Cape, 7530
Regeneron Research Site
Cape Town, Western Cape, 7925
Regeneron Research Site
Claremont, 7708
Regeneron Research Site
George, Western Cape, 6529
Regeneron Research Site
Halfway House, Gauteng, 1685
Regeneron Research Site
Johannesburg, 2013
Regeneron Research Site
Kempton Park, Johannesburg, 1619
Regeneron Research Site
Kuilsrivier, Cape Town, 7580
Regeneron Research Site
Paarl, Western Cape, 7646
Regeneron Research Site
Parow, Cape Town, 7500
Regeneron Research Site
Port Elizabeth, Eastern Cape, 6001
Regeneron Research Site
Pretoria, Gauteng, 0002
Regeneron Research Site
Pretoria, Gauteng, 0122
Regeneron Research Site
Pretoria, Gauteng, 0184
Regeneron Research Site
Pretoria West, Gauteng, 183
Regeneron Research Site
Somerset West, Western Cape, 7130
Regeneron Research Site
Soweto, Johannesburg, 1818
Regeneron Research Site
Worcester, Western Cape, 6850

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Ukraine15 sites

Regeneron Research Site #2
Kharkiv, 61002
Regeneron Research Site
Kharkiv, 61039
Regeneron Research Site
Kiev, 2091
Regeneron Research Site
Kyiv, 02002
Regeneron Research Site
Kyiv, 02660
Regeneron Research Site
Kyiv, 03037
Regeneron Research Site
Kyiv, 03049
Regeneron Research Site
Kyiv, 03115
Regeneron Research Site #2
Kyiv, 04114
Regeneron Research Site
Kyiv
Regeneron Research Site
Lviv, 79015
Regeneron Research Site
Uzhhorod, 88000
Regeneron Research Site
Vinnitsa, 21029
Regeneron Research Site
Vinnitsya, 21018
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Vinnytsia, 21018

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Bulgaria7 sites

Regeneron Research Site
Pleven, 5800
Regeneron Research Site
Plovdiv, 4000
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Sofia, 1309
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Sofia, 1407
Regeneron Research Site #2
Sofia, 1784
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Stara Zagora, 6000
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Varna, 9000

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Estonia5 sites

Regeneron Research Site
Paide, 72713
Regeneron Research Site
Tallinn, Harju, 10138
Regeneron Research Site #2
Tallinn, 10128
Regeneron Research Site
Tallinn, 10617
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Tartu, 51014

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About this study

Official title: Long Term Safety Study of PRALUENT in Patients With Heterozygous Familial Hypercholesterolemia or With Non-Familial Hypercholesterolemia at High and Very High Cardiovascular Risk and Previously Enrolled in the Neurocognitive Function Trial

The secondary objectives of the study were:

To evaluate the effect of PRALUENT on low-density lipoprotein cholesterol (LDL-C)
To evaluate the effect of PRALUENT on other lipid parameters
To evaluate the effect of PRALUENT on gonadal steroid hormones

Conditions: Heterozygous Familial Hypercholesterolemia, Non-familial Hypercholesterolemia
Being tested: Praluent

What participants receive

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

PraluentDrug
Also called Alirocumab, REGN727, SAR236553
Subcutaneous (SC) administration

Study groups in NCT03694197
Study group	Role	What they receive
Open label	Experimental	Not described Receives: Drug: Praluent

What is being measured

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

Number of Participants With Adverse Events (AE) After First Administration of Study Drug Through the Last Dose of Study Drug Plus 2 Weeks
An AE is any untoward medical occurrence in a participant administered a study drug which may or may not have a causal relationship with the study drug. AEs include serious adverse events (SAEs), AEs leading to treatment discontinuation, and adverse events of special interest (AESI). AESI include local injection site reactions, general allergic events, elevated alanine aminotransferase (ALT) levels greater than or equal to (≥) 3 upper limit normal (ULN) (if baseline is less than (<) ULN)/ALT ≥2 x ULN (if baseline ≥ ULN), neurologic events, neurocognitive events (according to Customized Medical Dictionary for Regulatory Activities [MedDRA] Query [CMQ] by Sponsor grouping and CMQ by FDA grouping), cataract, new onset diabetes (NOD), hepatic disorders, and diabetes mellitus (DM)/diabetic complications.
Measured: After first administration of study drug through the last dose of study drug plus 2 weeks, up to 80 weeks

Secondary outcomes (32)

Calculated Low-density Lipoprotein Cholesterol (LDL-C) Values From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Measured: Up to week 72
Percent Change in LDL-C From Baseline Over Time
Measured: Up to week 72
Total Cholesterol (Total-C) Values From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Measured: Up to week 72
Percent Change From Baseline in Total-C Over Time
Measured: Up to week 72
Lipoprotein a (Lp(a)) Values From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Measured: Up to week 72
Percent Change From Baseline in Lp(a) Over Time
Measured: Up to week 72
Non-high-density Lipoprotein Cholesterol (Non-HDL-C) Values From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Measured: Up to week 72
Percent Change From Baseline in Non-HDL-C Over Time
Measured: Up to week 72
High-density Lipoprotein Cholesterol (HDL-C) Values From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Measured: Up to week 72
Percent Change From Baseline in HDL-C Over Time
Measured: Up to week 72
Fasting Triglycerides (TGs) Values From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Measured: Up to week 72
Percent Change From Baseline in Fasting TGs Over Time
Measured: Up to week 72
Apolipoprotein B (Apo B) Values From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Measured: Up to week 72
Percent Change From Baseline in Apo B Over Time
Measured: Up to week 72
Apolipoprotein-A1 (Apo A1) Values From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Measured: Up to week 72
Percent Change From Baseline in Apo A1 Over Time
Measured: Up to week 72
Gonadal Hormone (Follicle Stimulating Hormone [FSH] and Luteinizing Hormone [LH]) Values for Female Participants From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Measured: Up to week 72
Change From Baseline in Gonadal Hormones (FSH and LH) for Female Participants Over Time
Measured: Up to week 72
Gonadal (FSH and LH) Hormone Values for Male Participants From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Measured: Up to week 72
Change From Baseline in Gonadal Hormones (FSH and LH) for Male Participants Over Time
Measured: Up to week 72
Gonadotropin (Estradiol) Values for Female Participants From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Measured: Up to week 72
Change From Baseline in Gonadotropins (Estradiol) for Female Participants Over Time
Measured: Up to week 72
Gonadotropin (Testosterone) Values for Male Participants From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Measured: Up to week 72
Change From Baseline in Gonadotropins (Testosterone) for Male Participants Over Time
Measured: Up to week 72
Alanine Aminotransferase Values From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Measured: Up to week 72
Change From Baseline in Alanine Aminotransferase Over Time
Measured: Up to week 72
Aspartate Aminotransferase Values From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Measured: Up to week 72
Change From Baseline in Aspartate Aminotransferase Over Time
Measured: Up to week 72
Alkaline Phosphatase Values From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Measured: Up to week 72
Change From Baseline in Alkaline Phosphatase Over Time
Measured: Up to week 72
Total Bilirubin Values From Baseline Over Time
The baseline value was defined as the last available value before the first dose of double-blind study treatment in study R727-CL-1532 (NCT02957682)
Measured: Up to week 72
Change From Baseline in Total Bilirubin Over Time
Measured: Up to week 72

Timeline

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

28 Sep 20188 Apr 2020

First posted3 Oct 2018
Study start28 Sep 2018
Primary completion8 Apr 2020
Study completion8 Apr 2020

Why it stopped: The primary objective (to evaluate the long-term safety of Praluent) was adequately evaluated in other studies.

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.
Other trials for Heterozygous Familial HypercholesterolemiaStudies of the same condition, open and under way.
More trials run by Regeneron PharmaceuticalsThe 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 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 1,389 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03694197
Sponsor's protocol ID: R727-CL-1609
Other IDs: 2018-002810-11, 2018
Status last verified: May 2021
First submitted: 6 Sep 2018
Last updated: 15 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

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
Assessment of the Prevalence of Steatotic Liver Disease Associated With Metabolic Dysfunction in Patients With Heterozygous Familial Hypercholesterolemia
Heterozygous Familial Hypercholesterolemia
Not yet recruitingPhase 1/2
EDIT-401 in Adults Who Require Additional Lowering of Low-Density Lipoprotein Cholesterol (LDL-C)
Heterozygous Familial Hypercholesterolemia (HeFH)
Recruiting
The ORIGIN-FH Study
Heterozygous Familial Hypercholesterolemia (HeFH), Homozygous Familial Hypercholesterolemia (HoFH)
RecruitingPhase 2/3
A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029)
Heterozygous Familial Hypercholesterolemia (HeFH)
Not yet recruitingPhase 2
A Study of VERVE-102 (LY4636581) in Adults With or at High Risk for Cardiovascular Disease
Atherosclerosis, Cardiovascular Disease

All Heterozygous Familial Hypercholesterolemia trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Long Term Safety Study of PRALUENT in Patients With Heterozygous Familial Hypercholesterolemia or With Non-Familial Hypercholesterolemia at High and Very High Cardiovascular Risk and Previously Enrolled in the Neurocognitive Function Trial
ClinicalTrials.gov ID: NCT03694197
Acronym / sponsor ID: R727-CL-1609
Conditions: Heterozygous Familial Hypercholesterolemia, Non-familial Hypercholesterolemia
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: The primary objective (to evaluate the long-term safety of Praluent) was adequately evaluated in other studies.
Enrolment: 1,389 participants (actual)
Lead sponsor: Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
Collaborators: Sanofi
Study start: 28 Sep 2018 (actual)
Primary completion: 8 Apr 2020 (actual)
Study completion: 8 Apr 2020 (actual)
First posted: 3 Oct 2018 (actual)
Results: Posted 15 Jun 2021

Clinical summary

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

The secondary objectives of the study were:

To evaluate the effect of PRALUENT on low-density lipoprotein cholesterol (LDL-C)
To evaluate the effect of PRALUENT on other lipid parameters
To evaluate the effect of PRALUENT on gonadal steroid hormones

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Open label	Experimental	Drug: Praluent

Who may qualify

Ages: 40 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Participants randomized into the neurocognitive function study (R727-CL-1532) who completed treatment and the end of study (EOS) visit with no premature or permanent discontinuation of study drug.

Key exclusion criteria (6 listed)

Significant protocol deviation in the parent study (neurocognitive function study R727-CL-1532: NCT02957682) based on the investigator's or sponsor's judgment, such as noncompliance
Any participant who experienced an AE leading to permanent discontinuation from the neurocognitive function study R727-CL-1532 (NCT02957682).
Any new condition or worsening of an existing condition which, in the opinion of the investigator or per the PRALUENT local label, would make the participant unsuitable for enrollment or could interfere with the participant participating in or completing the open-label extension (OLE) study
Known hypersensitivity to monoclonal antibody or any component of the drug product
Pregnant or breastfeeding women

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
PraluentAlso: Alirocumab, REGN727, SAR236553Subcutaneous (SC) administration	Drug	Open label

Primary outcome

Number of Participants With Adverse Events (AE) After First Administration of Study Drug Through the Last Dose of Study Drug Plus 2 Weeks
Time frame: After first administration of study drug through the last dose of study drug plus 2 weeks, up to 80 weeks
An AE is any untoward medical occurrence in a participant administered a study drug which may or may not have a causal relationship with the study drug. AEs include serious adverse events (SAEs), AEs leading to treatment discontinuation, and adverse events of special interest (AESI). AESI include local injection site reactions, general allergic events, elevated alanine aminotransferase (ALT) levels greater than or equal to (≥) 3 upper limit normal (ULN) (if baseline is less than (<) ULN)/ALT ≥2 x ULN (if baseline ≥ ULN), neurologic events, neurocognitive events (according to Customized Medical Dictionary for Regulatory Activities [MedDRA] Query [CMQ] by Sponsor grouping and CMQ by FDA grouping), cataract, new onset diabetes (NOD), hepatic disorders, and diabetes mellitus (DM)/diabetic complications.

32 secondary outcomes

Calculated Low-density Lipoprotein Cholesterol (LDL-C) Values From Baseline Over Time
Time frame: Up to week 72
Percent Change in LDL-C From Baseline Over Time
Time frame: Up to week 72
Total Cholesterol (Total-C) Values From Baseline Over Time
Time frame: Up to week 72
Percent Change From Baseline in Total-C Over Time
Time frame: Up to week 72
Lipoprotein a (Lp(a)) Values From Baseline Over Time
Time frame: Up to week 72
Percent Change From Baseline in Lp(a) Over Time
Time frame: Up to week 72
Non-high-density Lipoprotein Cholesterol (Non-HDL-C) Values From Baseline Over Time
Time frame: Up to week 72
Percent Change From Baseline in Non-HDL-C Over Time
Time frame: Up to week 72
High-density Lipoprotein Cholesterol (HDL-C) Values From Baseline Over Time
Time frame: Up to week 72
Percent Change From Baseline in HDL-C Over Time
Time frame: Up to week 72
Fasting Triglycerides (TGs) Values From Baseline Over Time
Time frame: Up to week 72
Percent Change From Baseline in Fasting TGs Over Time
Time frame: Up to week 72
Apolipoprotein B (Apo B) Values From Baseline Over Time
Time frame: Up to week 72
Percent Change From Baseline in Apo B Over Time
Time frame: Up to week 72
Apolipoprotein-A1 (Apo A1) Values From Baseline Over Time
Time frame: Up to week 72
Percent Change From Baseline in Apo A1 Over Time
Time frame: Up to week 72
Gonadal Hormone (Follicle Stimulating Hormone [FSH] and Luteinizing Hormone [LH]) Values for Female Participants From Baseline Over Time
Time frame: Up to week 72
Change From Baseline in Gonadal Hormones (FSH and LH) for Female Participants Over Time
Time frame: Up to week 72
Gonadal (FSH and LH) Hormone Values for Male Participants From Baseline Over Time
Time frame: Up to week 72
Change From Baseline in Gonadal Hormones (FSH and LH) for Male Participants Over Time
Time frame: Up to week 72
Gonadotropin (Estradiol) Values for Female Participants From Baseline Over Time
Time frame: Up to week 72
Change From Baseline in Gonadotropins (Estradiol) for Female Participants Over Time
Time frame: Up to week 72
Gonadotropin (Testosterone) Values for Male Participants From Baseline Over Time
Time frame: Up to week 72
Change From Baseline in Gonadotropins (Testosterone) for Male Participants Over Time
Time frame: Up to week 72
Alanine Aminotransferase Values From Baseline Over Time
Time frame: Up to week 72
Change From Baseline in Alanine Aminotransferase Over Time
Time frame: Up to week 72
Aspartate Aminotransferase Values From Baseline Over Time
Time frame: Up to week 72
Change From Baseline in Aspartate Aminotransferase Over Time
Time frame: Up to week 72
Alkaline Phosphatase Values From Baseline Over Time
Time frame: Up to week 72
Change From Baseline in Alkaline Phosphatase Over Time
Time frame: Up to week 72
Total Bilirubin Values From Baseline Over Time
Time frame: Up to week 72
Change From Baseline in Total Bilirubin Over Time
Time frame: Up to week 72

Results and safety

Results posted to the registry on 15 Jun 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Alirocumab 75 Q2W/Up150 Q2W	1,385	0

Primary outcome: Number of Participants With Adverse Events (AE) After First Administration of Study Drug Through the Last Dose of Study Drug Plus 2 Weeks

Time frame: After first administration of study drug through the last dose of study drug plus 2 weeks, up to 80 weeks. Number. Unit: Participants

Measure	Alirocumab 75 Q2W/Up150 Q2W n = 1385
Any treatment emergent adverse event (TEAE)	568
Any treatment emergent serious adverse event (SAE)	89
Any TEAE leading to death	5
Any TEAE leading to permanent treatment discontinuation	9
Any neurocognitive disorders TEAE (by Sponsor CMQ)	4
Any neurocognitive disorders TEAE (by FDA CMQ)	0
Any NOD; # analyzed = # of participants w/out diabetes at baseline	15
Any hepatic disorders TEAE	14

Population analysed: Safety analysis set (SAF): All participants who received any study drug

32 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were recorded from the time of signed informed consent until the end of study, up to 80 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Alirocumab 75 Q2W/Up150 Q2W	89 of 1,385 (6.4%)	0 of 1,385 (0%)	5 of 1,385

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Heterozygous Familial Hypercholesterolemia

Active, not recruitingObservational study
Assessment of the Prevalence of Steatotic Liver Disease Associated With Metabolic Dysfunction in Patients With Heterozygous Familial Hypercholesterolemia
Heterozygous Familial Hypercholesterolemia
Not yet recruitingPhase 1/2
EDIT-401 in Adults Who Require Additional Lowering of Low-Density Lipoprotein Cholesterol (LDL-C)
Heterozygous Familial Hypercholesterolemia (HeFH)
Recruiting
The ORIGIN-FH Study
Heterozygous Familial Hypercholesterolemia (HeFH), Homozygous Familial Hypercholesterolemia (HoFH)
RecruitingPhase 2/3
A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029)
Heterozygous Familial Hypercholesterolemia (HeFH)
Not yet recruitingPhase 2
A Study of VERVE-102 (LY4636581) in Adults With or at High Risk for Cardiovascular Disease
Atherosclerosis, Cardiovascular Disease

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.

Clinical Trial Management study director

Regeneron Pharmaceuticals

123 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Praluent in people with Heterozygous Familial Hypercholesterolemia and Non-familial Hypercholesterolemia, run by Regeneron Pharmaceuticals at 123 sites in 6 countries.

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 1 inclusion and 6 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: stopped early, as of the sponsor's last update on 15 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 123 sites in United States, Russia, South Africa, Ukraine, Bulgaria and 1 more country. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 15 Jun 2021). 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?

Number of Participants With Adverse Events (AE) After First Administration of Study Drug Through the Last Dose of Study Drug Plus 2 Weeks (time frame: After first administration of study drug through the last dose of study drug plus 2 weeks, up to 80 weeks). 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 NCT03694197.

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 15 Jun 2021.