Diabetes Melliuts, Type 2Phase 1NCT01673178
Multiple Dose Study Of PF-05231023 In Adult Subjects Who Have Poor Lipid Control With And Without Type 2 Diabetes Mellitus
A Phase 1 study testing 25 mg PF-05231023, 50 mg PF-05231023 and 100 mg PF-05231023 in people with Diabetes Melliuts, Type 2, run by Pfizer at 17 sites in United States.
Trial summary
This is a trial in obese subjects who have poor lipid control with and without Type 2 diabetes mellitus to study the safety, tolerability and pharmacokinetics of multiple doses of PF-05231023 Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Diabetes Melliuts, Type 2
- What is being tested?
- 25 mg PF-05231023, 50 mg PF-05231023 and 100 mg PF-05231023
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 107 participants
- Where
- 17 sitesUnited States
- Study dates
- Oct 2012to Sep 2013
- Phase
- Phase 1
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects of non-childbearing potential between the ages of 30 and 70 years with and without a diagnosis of Type 2 diabetes mellitus (according to the American Diabetes Association guidelines).
- Subjects with poor lipid control as confirmed by laboratory tests.
- BMI of 30 to 40 Kg/m2 and a total body weight of >50 kg (110 lbs).
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding asymptomatic, seasonal allergies at time of dosing).
- Levels of blood enzymes indicating pancreatitis or elevated liver function enzymes outside of the laboratory's reference range as confirmed by laboratory tests.
- Subjects with Type 1 Diabetes Mellitus.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Anaheim Clinical Trials, LLC
Anaheim, California, 92801
Profil Institute for Clinical Research, Inc.
Chula Vista, California, 91911
Medpace Clinical Pharmacology Unit
Cincinnati, Ohio, 45227
Community Research
Cincinnati, Ohio, 45255
Mercy Hospital Pharmacy
Cincinnati, Ohio, 45255
Covance Clinical Research Unit
Dallas, Texas, 75247
Avail Clinical Research, LLC
DeLand, Florida, 32720
High Point Clinical Trials Center, LLC
High Point, North Carolina, 27265
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, 40509
L-MARC Research Center
Louisville, Kentucky, 40213
Elite Research Institute
Miami, Florida, 33169
Carolina Phase 1 Research
Raleigh, North Carolina, 27612
Wake Internal Medicine Consultants
Raleigh, North Carolina, 27612
Prism Research
Saint Paul, Minnesota, 55114
Miami Research Associates, Inc.
South Miami, Florida, 33143
MRA Clinical Research, LLC
South Miami, Florida, 33143
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
About this study
Official title: A Phase 1, Placebo-controlled, Randomized Trial To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Iv Doses Of Pf-05231023 In Obese Hyperlipidemic Adult Subjects With And Without Type 2 Diabetes Mellitus On A Background Of Atorvastatin
This is a trial in obese subjects who have poor lipid control with and without Type 2 diabetes mellitus to study the safety, tolerability and pharmacokinetics of multiple doses of PF-05231023
- Conditions
- Diabetes Melliuts, Type 2
- Being tested
- Placebo, 25 mg PF-05231023, 50 mg PF-05231023, 100 mg PF-05231023, 150 mg PF-05231023
- Keywords
- Type 2 diabetes, safety, multiple dose, intravenous
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
0.9% w/v sodium chloride injection, United States Pharmacopeia (USP), once a week for 4 weeks
25 mg PF-05231023Drug
25 mg IV once a week for 4 weeks
50 mg PF-05231023Drug
50 mg IV once a week for 4 weeks
100 mg PF-05231023Drug
100 mg IV once a week for 4 weeks
150 mg PF-05231023Drug
150 mg IV once a week for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo Arm | Placebo comparator | Not described Receives: Other: Placebo |
| 25 mg | Experimental | Not described Receives: Drug: 25 mg PF-05231023 |
| 50 mg | Experimental | Not described Receives: Drug: 50 mg PF-05231023 |
| 100 mg | Experimental | Not described Receives: Drug: 100 mg PF-05231023 |
| 150 mg | Experimental | Not described Receives: Drug: 150 mg PF-05231023 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An 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. Treatment-emergent events were between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.
Measured: Baseline up to 28 days after last dose
Number of Participants With Laboratory Abnormalities
Criteria for laboratory test abnormality: Hematology (hemoglobin, hematocrit, red blood corpuscles [RBC] count: less than [<]0.8*lower limit of normal [LLN], platelets: <0.5*LLN/greater than [>]1.75*upper limit of normal [ULN], leukocytes: <0.6*LLN or >1.5*ULN, lymphocytes, total neutrophils: <0.8*LLN or >1.2*ULN, basophils, eosinophil: <0.8*LLN, monocytes: >1.2*ULN); Liver Function (aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: >0.3*ULN, total protein, albumin: <0.8*LLN or >1.2*ULN); total bilirubin, direct bilirubin, indirect bilirubin: >1.5*ULN; Renal Function (blood urea nitrogen, creatinine: >1.3*ULN, uric acid: >1.2*ULN); Electrolytes (sodium: <0.95*LLN or >1.05*ULN, potassium, chloride, calcium, bicarbonate: <0.9*LLN or >1.1*ULN; creatine kinase: >2.0*ULN; glucose fasting: <0.6*LLN or >1.5*ULN, urine white blood corpuscles [WBC] and RBC: greater than or equal to (>=) 20/High Power Field [HPF]).
Measured: Baseline up to Day 49
Number of Participants With Clinically Significant Vital Sign Abnormalities
Criteria for clinically significant vital signs abnormalities included supine/sitting pulse rate of <40 beats per minute (bpm) or >120 bpm, supine systolic blood pressure (SBP) of <90 millimeter of mercury (mmHg), >=30 mmHg maximum increase and decrease from baseline in same posture, supine diastolic blood pressure (DBP) of <50 mmHg; >=20 mmHg maximum increase and decrease from baseline in same posture.
Measured: Baseline up to Day 49
Number of Participants With Clinically Significant Electrocardiogram Findings
Clinically significant ECG findings included PR interval >=300 milliseconds (msec) or >=25 percent (%) increase from baseline (if baseline PR interval >200 msec) or >=50% increase (if baseline PR interval less than or equal to [<=] 200 msec); QRS interval >=140 msec or >=50% increase from baseline; QT interval >=500 msec, corrected QT interval based on Fridericia's formula (QTcF) 450 to <480 msec, 480 to <500 msec, >=500 msec or >=30 msec but <60 msec increase from baseline or >=60 msec increase from baseline.
Measured: Baseline up to Day 49
Number of Participants With Abnormal Physical Examinations
Physical examination included general examination and examination of head, ears, eyes, nose, mouth, throat, neck, abdomen, skin, heart, lungs, lymph nodes, and gastrointestinal and musculoskeletal and neurological system.
Measured: Baseline up to Day 49
Thyroid Stimulating Hormone (TSH) Level at Baseline
Results are reported in micro international units per milliliter (mcIU/mL).
Measured: Baseline
Thyroid Stimulating Hormone (TSH) Level at Day 1
Measured: Day 1
Thyroid Stimulating Hormone (TSH) Level at Day 25
Measured: Day 25
Thyroid Stimulating Hormone (TSH) Level at Day 39
Measured: Day 39
Thyroid Stimulating Hormone (TSH) Level at Day 49
Measured: Day 49
Phosphate Level at Baseline
Measured: Baseline
Change From Baseline in Phosphate Level at Day 8
Measured: Baseline, Day 8
Change From Baseline in Phosphate Level at Day 15
Measured: Baseline, Day 15
Change From Baseline in Phosphate Level at Day 25
Measured: Baseline, Day 25
Change From Baseline in Phosphate Level at Day 49
Measured: Baseline, Day 49
Creatine Phosphokinase (CPK) Level at Baseline
Measured: Baseline
Change From Baseline in Creatine Phosphokinase (CPK) Level at Day 8
Measured: Baseline, Day 8
Change From Baseline in Creatine Phosphokinase (CPK) Level at Day 15
Measured: Baseline, Day 15
Change From Baseline in Creatine Phosphokinase (CPK) Level at Day 25
Measured: Baseline, Day 25
Change From Baseline in Creatine Phosphokinase (CPK) Level at Day 49
Measured: Baseline, Day 49
Serum N-terminal Propeptides of Type 1 Collagen (PINP) and C-Telopeptide Cross-Linking of Type 1 Collagen (CTX) Levels at Baseline
Measured: Baseline
Percent Change From Baseline in Serum N-terminal Propeptides of Type 1 Collagen (PINP) and C-Telopeptide Cross-Linking of Type 1 Collagen (CTX) Levels at Day 25
Measured: Baseline, Day 25
Percent Change From Baseline in Serum N-terminal Propeptides of Type 1 Collagen (PINP) and C-Telopeptide Cross-Linking of Type 1 Collagen (CTX) Levels at Day 39
Measured: Baseline, Day 39
Percent Change From Baseline Serum N-terminal Propeptides of Type 1 Collagen (PINP) and C-Telopeptide Cross-Linking of Type 1 Collagen (CTX) Levels at Day 49
Measured: Baseline, Day 49
Blood Osteocalcin and Bone-Specific Alkaline Phosphatase Levels at Baseline
Measured: Baseline
Percent Change From Baseline in Blood Osteocalcin and Bone-Specific Alkaline Phosphatase Levels at Day 25
Measured: Baseline, Day 25
Percent Change From Baseline in Blood Osteocalcin and Bone-Specific Alkaline Phosphatase Levels at Day 39
Measured: Baseline, Day 39
Percent Change From Baseline in Blood Osteocalcin and Bone-Specific Alkaline Phosphatase Levels at Day 49
Measured: Baseline, Day 49
Tartrate-resistant Acid Phosphatase Isoform 5b (TRAP 5b) Levels at Baseline
Measured: Baseline
Percent Change From Baseline in Tartrate-resistant Acid Phosphatase Isoform 5b (TRAP 5b) Levels at Day 25
Measured: Baseline, Day 25
Percent Change From Baseline in Tartrate-resistant Acid Phosphatase Isoform 5b (TRAP 5b) Levels at Day 39
Measured: Baseline, Day 39
Percent Change From Baseline in Tartrate-resistant Acid Phosphatase Isoform 5b (TRAP 5b) Levels at Day 49
Measured: Day 49
Average Urinary Calcium and Phosphate Levels Over 24 Hours at Baseline
Measured: Baseline
Change From Baseline in Average Urinary Calcium and Phosphate Levels Over 24 Hours at Day 24
Measured: Day 24
Number of Participants With Anti-PF-05231023 Antibodies and Neutralizing Antibodies at Day 1
Anti-PF-05231023 antibodies and neutralizing antibodies were analyzed only for participants who received PF-05231023 as per planned analysis. One sample at Day 1 was inadvertently tested for neutralizing antibody even though the corresponding anti-PF-05231023 antibody was negative.
Measured: Day 1
Number of Participants With Anti-PF-05231023 Antibodies and Neutralizing Antibodies at Day 39
Anti-PF-05231023 antibodies and neutralizing antibodies were analyzed only for participants who received PF-05231023 as per planned analysis. One sample at Day 39 was inadvertently tested for neutralizing antibody even though the corresponding anti-PF-05231023 antibody was negative.
Measured: Day 39
Number of Participants With Anti-PF-05231023 Antibodies and Neutralizing Antibodies at Day 49
Measured: Day 49
Secondary outcomes (12)
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-05231023 After Single Dose
AUCtau was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.
Measured: 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1, Day 4, 0 hours (pre-dose) on Day 8
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05231023 After Single Dose
Tmax was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.
Measured: 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1, Day 4, 0 hour (pre-dose) on Day 8
Maximum Observed Plasma Concentration (Cmax) of PF-05231023 After Single Dose
Cmax was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.
Measured: 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1, Day 4, 0 hour (pre-dose) on Day 8
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-05231023 After Last Dose
AUCtau was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.
Measured: 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05231023 After Last Dose
Tmax was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.
Measured: 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49
Maximum Observed Plasma Concentration (Cmax) of PF-05231023 After Last Dose
Cmax was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.
Measured: 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49
Accumulation Ratio for Area Under the Curve From Time Zero to End of Dosing Interval (Rac) of PF-05231023
Rac was obtained from AUCtau after last dose (Day 22) divided by AUCtau after single dose (Day 1). Rac was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.
Measured: 0 (pre-dose), 0.5 (end of infusion ), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1; Day 4, 0 hour (pre-dose) on Day 8; 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22; Day 24, 25, 29
Accumulation Ratio for Maximum Observed Plasma Concentration (Rac,Cmax) of PF-05231023
Rac was obtained from AUCtau after last dose (Day 22) divided by AUCtau after single dose (Day 1). Rac was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.
Measured: 0 (pre-dose),0.5(end of infusion), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1; Day 4, 0 hour (pre-dose) on Day 8; 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22; Day 24,25,29,39,49
Minimum Observed Plasma Trough Concentration (Cmin) of PF-05231023 After Last Dose
Cmin was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.
Measured: 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49
Average Plasma Concentration (Cav ) of PF-05231023 After the Last Dose
Cav was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.
Measured: 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49
Plasma Decay Half-Life (t1/2) of PF-05231023
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Half-Life was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.
Measured: 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49
Apparent Clearance (CL) of PF-05231023
CL is a quantitative measure of the rate at which a drug substance is removed from the body. CL was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.
Measured: 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2012 (estimated)
- Study startOct 2012
- Primary completionAug 2013
- Study completionSep 2013
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 (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Melliuts, Type 2Studies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01673178
- Sponsor's protocol ID
- B2901011
- Status last verified
- Jan 2015
- First submitted
- 22 Aug 2012
- Last updated
- 16 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kim AM, Somayaji VR, Dong JQ, Rolph TP, Weng Y, Chabot JR, Gropp KE, Talukdar S, Calle RA. Once-weekly administration of a long-acting fibroblast growth factor 21 analogue modulates lipids, bone turnover markers, blood pressure and body weight differently in obese people with hypertriglyceridaemia and in non-human primates. Diabetes Obes Metab. 2017 Dec;19(12):1762-1772. doi: 10.1111/dom.13023. Epub 2017 Jul 21.
PubMed 28573777
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Placebo-controlled, Randomized Trial To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Iv Doses Of Pf-05231023 In Obese Hyperlipidemic Adult Subjects With And Without Type 2 Diabetes Mellitus On A Background Of Atorvastatin
- ClinicalTrials.gov ID
- NCT01673178
- Acronym / sponsor ID
- B2901011
- Conditions
- Diabetes Melliuts, Type 2
- Keywords
- Type 2 diabetes, safety, multiple dose, intravenous
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 27 Aug 2012 (estimated)
- Results
- Posted 14 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a trial in obese subjects who have poor lipid control with and without Type 2 diabetes mellitus to study the safety, tolerability and pharmacokinetics of multiple doses of PF-05231023
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo Arm | Placebo comparator | Other: Placebo |
| 25 mg | Experimental | Drug: 25 mg PF-05231023 |
| 50 mg | Experimental | Drug: 50 mg PF-05231023 |
| 100 mg | Experimental | Drug: 100 mg PF-05231023 |
| 150 mg | Experimental | Drug: 150 mg PF-05231023 |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female subjects of non-childbearing potential between the ages of 30 and 70 years with and without a diagnosis of Type 2 diabetes mellitus (according to the American Diabetes Association guidelines).
- Subjects with poor lipid control as confirmed by laboratory tests.
- BMI of 30 to 40 Kg/m2 and a total body weight of >50 kg (110 lbs).
Key exclusion criteria (3 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding asymptomatic, seasonal allergies at time of dosing).
- Levels of blood enzymes indicating pancreatitis or elevated liver function enzymes outside of the laboratory's reference range as confirmed by laboratory tests.
- Subjects with Type 1 Diabetes Mellitus.
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 |
|---|---|---|
| Placebo0.9% w/v sodium chloride injection, United States Pharmacopeia (USP), once a week for 4 weeks | Other | Placebo Arm |
| 25 mg PF-0523102325 mg IV once a week for 4 weeks | Drug | 25 mg |
| 50 mg PF-0523102350 mg IV once a week for 4 weeks | Drug | 50 mg |
| 100 mg PF-05231023100 mg IV once a week for 4 weeks | Drug | 100 mg |
| 150 mg PF-05231023150 mg IV once a week for 4 weeks | Drug | 150 mg |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Baseline up to 28 days after last dose
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An 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. Treatment-emergent events were between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.
Number of Participants With Laboratory Abnormalities
Time frame: Baseline up to Day 49
Criteria for laboratory test abnormality: Hematology (hemoglobin, hematocrit, red blood corpuscles [RBC] count: less than [<]0.8*lower limit of normal [LLN], platelets: <0.5*LLN/greater than [>]1.75*upper limit of normal [ULN], leukocytes: <0.6*LLN or >1.5*ULN, lymphocytes, total neutrophils: <0.8*LLN or >1.2*ULN, basophils, eosinophil: <0.8*LLN, monocytes: >1.2*ULN); Liver Function (aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: >0.3*ULN, total protein, albumin: <0.8*LLN or >1.2*ULN); total bilirubin, direct bilirubin, indirect bilirubin: >1.5*ULN; Renal Function (blood urea nitrogen, creatinine: >1.3*ULN, uric acid: >1.2*ULN); Electrolytes (sodium: <0.95*LLN or >1.05*ULN, potassium, chloride, calcium, bicarbonate: <0.9*LLN or >1.1*ULN; creatine kinase: >2.0*ULN; glucose fasting: <0.6*LLN or >1.5*ULN, urine white blood corpuscles [WBC] and RBC: greater than or equal to (>=) 20/High Power Field [HPF]).
Number of Participants With Clinically Significant Vital Sign Abnormalities
Time frame: Baseline up to Day 49
Criteria for clinically significant vital signs abnormalities included supine/sitting pulse rate of <40 beats per minute (bpm) or >120 bpm, supine systolic blood pressure (SBP) of <90 millimeter of mercury (mmHg), >=30 mmHg maximum increase and decrease from baseline in same posture, supine diastolic blood pressure (DBP) of <50 mmHg; >=20 mmHg maximum increase and decrease from baseline in same posture.
Number of Participants With Clinically Significant Electrocardiogram Findings
Time frame: Baseline up to Day 49
Clinically significant ECG findings included PR interval >=300 milliseconds (msec) or >=25 percent (%) increase from baseline (if baseline PR interval >200 msec) or >=50% increase (if baseline PR interval less than or equal to [<=] 200 msec); QRS interval >=140 msec or >=50% increase from baseline; QT interval >=500 msec, corrected QT interval based on Fridericia's formula (QTcF) 450 to <480 msec, 480 to <500 msec, >=500 msec or >=30 msec but <60 msec increase from baseline or >=60 msec increase from baseline.
Number of Participants With Abnormal Physical Examinations
Time frame: Baseline up to Day 49
Physical examination included general examination and examination of head, ears, eyes, nose, mouth, throat, neck, abdomen, skin, heart, lungs, lymph nodes, and gastrointestinal and musculoskeletal and neurological system.
Thyroid Stimulating Hormone (TSH) Level at Baseline
Time frame: Baseline
Results are reported in micro international units per milliliter (mcIU/mL).
Thyroid Stimulating Hormone (TSH) Level at Day 1
Time frame: Day 1
Thyroid Stimulating Hormone (TSH) Level at Day 25
Time frame: Day 25
Thyroid Stimulating Hormone (TSH) Level at Day 39
Time frame: Day 39
Thyroid Stimulating Hormone (TSH) Level at Day 49
Time frame: Day 49
Phosphate Level at Baseline
Time frame: Baseline
Change From Baseline in Phosphate Level at Day 8
Time frame: Baseline, Day 8
Change From Baseline in Phosphate Level at Day 15
Time frame: Baseline, Day 15
Change From Baseline in Phosphate Level at Day 25
Time frame: Baseline, Day 25
Change From Baseline in Phosphate Level at Day 49
Time frame: Baseline, Day 49
Creatine Phosphokinase (CPK) Level at Baseline
Time frame: Baseline
Change From Baseline in Creatine Phosphokinase (CPK) Level at Day 8
Time frame: Baseline, Day 8
Change From Baseline in Creatine Phosphokinase (CPK) Level at Day 15
Time frame: Baseline, Day 15
Change From Baseline in Creatine Phosphokinase (CPK) Level at Day 25
Time frame: Baseline, Day 25
Change From Baseline in Creatine Phosphokinase (CPK) Level at Day 49
Time frame: Baseline, Day 49
Serum N-terminal Propeptides of Type 1 Collagen (PINP) and C-Telopeptide Cross-Linking of Type 1 Collagen (CTX) Levels at Baseline
Time frame: Baseline
Percent Change From Baseline in Serum N-terminal Propeptides of Type 1 Collagen (PINP) and C-Telopeptide Cross-Linking of Type 1 Collagen (CTX) Levels at Day 25
Time frame: Baseline, Day 25
Percent Change From Baseline in Serum N-terminal Propeptides of Type 1 Collagen (PINP) and C-Telopeptide Cross-Linking of Type 1 Collagen (CTX) Levels at Day 39
Time frame: Baseline, Day 39
Percent Change From Baseline Serum N-terminal Propeptides of Type 1 Collagen (PINP) and C-Telopeptide Cross-Linking of Type 1 Collagen (CTX) Levels at Day 49
Time frame: Baseline, Day 49
Blood Osteocalcin and Bone-Specific Alkaline Phosphatase Levels at Baseline
Time frame: Baseline
Percent Change From Baseline in Blood Osteocalcin and Bone-Specific Alkaline Phosphatase Levels at Day 25
Time frame: Baseline, Day 25
Percent Change From Baseline in Blood Osteocalcin and Bone-Specific Alkaline Phosphatase Levels at Day 39
Time frame: Baseline, Day 39
Percent Change From Baseline in Blood Osteocalcin and Bone-Specific Alkaline Phosphatase Levels at Day 49
Time frame: Baseline, Day 49
Tartrate-resistant Acid Phosphatase Isoform 5b (TRAP 5b) Levels at Baseline
Time frame: Baseline
Percent Change From Baseline in Tartrate-resistant Acid Phosphatase Isoform 5b (TRAP 5b) Levels at Day 25
Time frame: Baseline, Day 25
Percent Change From Baseline in Tartrate-resistant Acid Phosphatase Isoform 5b (TRAP 5b) Levels at Day 39
Time frame: Baseline, Day 39
Percent Change From Baseline in Tartrate-resistant Acid Phosphatase Isoform 5b (TRAP 5b) Levels at Day 49
Time frame: Day 49
Average Urinary Calcium and Phosphate Levels Over 24 Hours at Baseline
Time frame: Baseline
Change From Baseline in Average Urinary Calcium and Phosphate Levels Over 24 Hours at Day 24
Time frame: Day 24
Number of Participants With Anti-PF-05231023 Antibodies and Neutralizing Antibodies at Day 1
Time frame: Day 1
Anti-PF-05231023 antibodies and neutralizing antibodies were analyzed only for participants who received PF-05231023 as per planned analysis. One sample at Day 1 was inadvertently tested for neutralizing antibody even though the corresponding anti-PF-05231023 antibody was negative.
Number of Participants With Anti-PF-05231023 Antibodies and Neutralizing Antibodies at Day 39
Time frame: Day 39
Anti-PF-05231023 antibodies and neutralizing antibodies were analyzed only for participants who received PF-05231023 as per planned analysis. One sample at Day 39 was inadvertently tested for neutralizing antibody even though the corresponding anti-PF-05231023 antibody was negative.
Number of Participants With Anti-PF-05231023 Antibodies and Neutralizing Antibodies at Day 49
Time frame: Day 49
12 secondary outcomes
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-05231023 After Single Dose
Time frame: 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1, Day 4, 0 hours (pre-dose) on Day 8
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05231023 After Single Dose
Time frame: 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1, Day 4, 0 hour (pre-dose) on Day 8
Maximum Observed Plasma Concentration (Cmax) of PF-05231023 After Single Dose
Time frame: 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1, Day 4, 0 hour (pre-dose) on Day 8
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-05231023 After Last Dose
Time frame: 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05231023 After Last Dose
Time frame: 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49
Maximum Observed Plasma Concentration (Cmax) of PF-05231023 After Last Dose
Time frame: 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49
Accumulation Ratio for Area Under the Curve From Time Zero to End of Dosing Interval (Rac) of PF-05231023
Time frame: 0 (pre-dose), 0.5 (end of infusion ), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1; Day 4, 0 hour (pre-dose) on Day 8; 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22; Day 24, 25, 29
Accumulation Ratio for Maximum Observed Plasma Concentration (Rac,Cmax) of PF-05231023
Time frame: 0 (pre-dose),0.5(end of infusion), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1; Day 4, 0 hour (pre-dose) on Day 8; 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22; Day 24,25,29,39,49
Minimum Observed Plasma Trough Concentration (Cmin) of PF-05231023 After Last Dose
Time frame: 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49
Average Plasma Concentration (Cav ) of PF-05231023 After the Last Dose
Time frame: 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49
Plasma Decay Half-Life (t1/2) of PF-05231023
Time frame: 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49
Apparent Clearance (CL) of PF-05231023
Time frame: 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28573777Kim AM, Somayaji VR, Dong JQ, Rolph TP, Weng Y, Chabot JR, Gropp KE, Talukdar S, Calle RA. Once-weekly administration of a long-acting fibroblast growth factor 21 analogue modulates lipids, bone turnover markers, blood pressure and body weight differently in obese people with hypertriglyceridaemia and in non-human primates. Diabetes Obes Metab. 2017 Dec;19(12):1762-1772. doi: 10.1111/dom.13023. Epub 2017 Jul 21.
- 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
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 25 mg PF-05231023, 50 mg PF-05231023 and 100 mg PF-05231023 in people with Diabetes Melliuts, Type 2, run by Pfizer at 17 sites in United States.
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 3 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 16 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 14 Jan 2015). 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 Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Baseline up to 28 days after last dose). The study lists 37 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 NCT01673178, which also lists 1 linked publication.
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 16 Feb 2015.