ObesityPhase 2NCT04707313
A Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With Obesity
A Phase 2 study testing PF-06882961 (Cohorts 1 and 2) and PF-06882961 (Cohort 3) in people with Obesity, run by Pfizer at 41 sites in 4 countries.
Trial summary
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-06882961) for the potential treatment of obesity. The study will compare the experiences of participants taking the study medicine (PF-06882961) to those of participants who take placebo (a look- alike… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity
- What is being tested?
- PF-06882961 (Cohorts 1 and 2) and PF-06882961 (Cohort 3)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 628 participants
- Where
- 41 sitesin 4 countries
- Study dates
- 29 Jan 2021to 11 Oct 2023
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with obesity, defined as a Body Mass Index greater than or equal to 30.0 kg/m2
- Stable body weight, defined as <5 kg change (per participant report) for 90 days before visit 1
Who cannot join
- Any condition possibly affecting drug absorption
- Current or prior diagnosis of Type 1 or Type 2 diabetes mellitus or secondary forms of diabetes
- History of myocardial infarction, unstable angina, arterial revascularization, stroke, heart failure, or transient ischemic attack within 6 months prior to visit 1
- Any malignancy not considered cured
- Personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 or suspected MTC
- History of acute pancreatitis within 180 days (6 months) prior to visit 1 or any history of chronic pancreatitis
Show all 16Show fewer
- Symptomatic gallbladder disease
- Medical history or characteristics suggestive of genetic or syndromic obesity or obesity induced by other endocrinological disorders
- History of major depressive disorder or other severe psychiatric disorders within the last 2 years
- Any lifetime history of a suicide attempt
- Known medical history of active liver disease, including chronic active hepatitis B or C, or primary biliary cirrhosis
- Known history of HIV
- Supine blood pressure greater than or equal to 160 mmHg (systolic) or greater than or equal to 100 mmHg (diastolic)
- Clinically relevant ECG abnormalities
- Positive urine drug screen
- Participation in a formal weight reduction program within 90 days prior to visit 1
Trial locations and contacts
41 sites in 4 countries.
41 sites in 4 countries
United States27 sites
Anaheim Clinical Trials, LLC
Anaheim, California, 92801
Pinnacle Research Group, LLC
Anniston, Alabama, 36207
Internal Medicine and Pediatric Associates of Bristol, PC
Bristol, Tennessee, 37620
Velocity Clinical Research, Inc.
Cleveland, Ohio, 44122
Alliance for Multispecialty Research, LLC
Coral Gables, Florida, 33134
MediSphere Medical Research Center, LLC
Evansville, Indiana, 47714
Lillestol Research LLC
Fargo, North Dakota, 58104
Clinical Investigation Specialists
Gurnee, Illinois, 60031
PMG Research of Hickory, LLC
Hickory, North Carolina, 28601
PMG Research, Inc. d/b/a PMG Research of Knoxville
Knoxville, Tennessee, 37938
Velocity Clinical Research - Westlake
Los Angeles, California, 90057
L-MARC Research Center
Louisville, Kentucky, 40213
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, 38119
ActivMed Practices & Research, LLC
Methuen, Massachusetts, 01844
Optimus U Corporation
Miami, Florida, 33125
Clinical Trials of South Carolina
Moncks Corner, South Carolina, 29461
Coastal Carolina Research Center
North Charleston, South Carolina, 29405
Velocity Clinical Research, Omaha
Omaha, Nebraska, 68134
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801
PMG Research of Raleigh, LLC
Raleigh, North Carolina, 27609
PMG Research of Salisbury, LLC
Salisbury, North Carolina, 28144
Palmetto Clinical Research
Summerville, South Carolina, 29485
Palmetto Primary Care Physicians (Sub-I physicals only)
Summerville, South Carolina, 29485
ForCare Clinical Research
Tampa, Florida, 33613
Cotton O'Neil Clinical Research Center
Topeka, Kansas, 66606
Velocity Clinical Research, Valparaiso
Valparaiso, Indiana, 46383
Accellacare - Wilmington
Wilmington, North Carolina, 28401
Canada8 sites
Aggarwal and Associates Limited
Brampton, Ontario, L6T 0G1
Ecogene-21
Chicoutimi, Quebec, G7H 7K9
Milestone Research , Inc
London, Ontario, N5W 6A2
Alpha Recherche Clinique
Québec, Quebec, G2J 0C4
Centre de Recherche Saint-Louis
Québec, G1W4R4
Diex Recherche Sherbrooke Inc.
Sherbrooke, Quebec, J1L 0H8
Manna Research Toronto
Toronto, Ontario, M9W 4L6
Rivergrove Medical Clinic
Winnipeg, Manitoba, R2V 4W3
Japan4 sites
Tokyo Center Clinic
Chuo-ku, Tokyo, 103-0028
Fukuwa Clinic
Chuo-ku, Tokyo, 104-0031
Medical Corporation Heishinkai ToCROM Clinic
Shinjuku-ku, Tokyo, 160-0008
Medical Corporation Heishinkai OCROM Clinic
Suita-shi, Osaka, 565-0853
Taiwan2 sites
China Medical University Hospital
Taichung, 40447
National Cheng Kung University Hospital
Tainan, 704
About this study
Official title: A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-06882961 ADMINISTRATION IN ADULTS WITH OBESITY
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-06882961) for the potential treatment of obesity. The study will compare the experiences of participants taking the study medicine (PF-06882961) to those of participants who take placebo (a look- alike substance that contains no active study medicine). The aim is to measure the body's response to the study medicine, including any changes in participants' body weight, waist and hip measurements, how well they tolerate the study medicine, and to measure levels of the study medicine in participants' blood.
This study is seeking participants who have obesity, who do not have diabetes and who have had a stable body weight and not participated in a formal weight loss program in the 90 days before the study. The study medicine or placebo will be taken as tablets by mouth 2 times a day (1 time in the morning and 1 time in the evening).
There are 3 groups of participants (called cohorts) in this study. For participants in Cohorts 1 and 2, total study participation will be about 9 months, with 15 planned study visits (14 visits to the study clinic and 1 telephone call). For participants in Cohort 3, total study participation will be about 10 months, with 21 planned study visits (12 visits to the study clinic and 9 telephone calls).
- Conditions
- Obesity
- Being tested
- Placebo (Cohorts 1 and 2), PF-06882961 (Cohorts 1 and 2), Placebo (Cohort 3), PF-06882961 (Cohort 3)
- Keywords
- Weight loss
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo (Cohorts 1 and 2)Drug
4 matching placebo tablets taken twice daily
PF-06882961 (Cohorts 1 and 2)Drug
Participants will be randomized to one of 5 active target dose levels (40, 80, 120, 160 or 200 mg BID) achieved through 1-week titration steps, or 3 active target dose levels (120, 160 or 200 mg BID) achieved through 2-week titration steps, taking 4 tablets twice daily
Placebo (Cohort 3)Drug
2 matching placebo tablets taken twice daily
PF-06882961 (Cohort 3)Drug
Participants will be randomized to one of 3 active target dose levels (80, 140 or 200 mg BID) achieved through 4-week titration steps, taking 2 tablets twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Placebo (Cohorts 1 and 2) | Placebo comparator | Not described Receives: Drug: Placebo (Cohorts 1 and 2) |
| PF-06882961 40 milligrams (mg) twice daily (BID), 1-week titration (Cohort 1) | Experimental | The dose will be titrated with 1 week of dosing at each step to reach the target dose of 40 mg BID. Receives: Drug: PF-06882961 (Cohorts 1 and 2) |
| PF-06882961 80 mg BID, 1-week titration (Cohort 1) | Experimental | The dose will be titrated with 1 week of dosing at each step to reach the target dose of 80 mg BID. Receives: Drug: PF-06882961 (Cohorts 1 and 2) |
| PF-06882961 120 mg BID, 1-week titration (Cohort 1) | Experimental | The dose will be titrated with 1 week of dosing at each step to reach the target dose of 120 mg BID. Receives: Drug: PF-06882961 (Cohorts 1 and 2) |
| PF-06882961 160 mg BID, 1-week titration (Cohort 1) | Experimental | The dose will be titrated with 1 week of dosing at each step to reach the target dose of 160 mg BID. Receives: Drug: PF-06882961 (Cohorts 1 and 2) |
| PF-06882961 200 mg BID, 1-week titration (Cohort 1) | Experimental | The dose will be titrated with 1 week of dosing at each step to reach the target dose of 200 mg BID. Receives: Drug: PF-06882961 (Cohorts 1 and 2) |
| PF-06882961 120 mg BID, 2-week titration (Cohorts 1 and 2) | Experimental | The dose will be titrated with 2 weeks of dosing at each step to reach the target dose of 120 mg BID. Receives: Drug: PF-06882961 (Cohorts 1 and 2) |
| PF-06882961 160 mg BID, 2-week titration (Cohorts 1 and 2) | Experimental | The dose will be titrated with 2 weeks of dosing at each step to reach the target dose of 160 mg BID. Receives: Drug: PF-06882961 (Cohorts 1 and 2) |
| PF-06882961 200 mg BID, 2-week titration (Cohorts 1 and 2) | Experimental | The dose will be titrated with 2 weeks of dosing at each step to reach the target dose of 200 mg BID. Receives: Drug: PF-06882961 (Cohorts 1 and 2) |
| Placebo (Cohort 3) | Placebo comparator | Not described Receives: Drug: Placebo (Cohort 3) |
| PF-06882961 80 mg BID, 4-week titration (Cohort 3) | Experimental | The dose will be titrated with 4 weeks of dosing at each step to reach the target dose of 80 mg BID. Receives: Drug: PF-06882961 (Cohort 3) |
| PF-06882961 140 mg BID, 4-week titration (Cohort 3) | Experimental | The dose will be titrated with 4 weeks of dosing at each step to reach the target dose of 140 mg BID. Receives: Drug: PF-06882961 (Cohort 3) |
| PF-06882961 200 mg BID, 4-week titration (Cohort 3) | Experimental | The dose will be titrated with 4 weeks of dosing at each step to reach the target dose of 200 mg BID. Receives: Drug: PF-06882961 (Cohort 3) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohorts 1 and 2: Percent Change From Baseline in Body Weight at End of Treatment at Week 26
Percent change from baseline in body weight at end of treatment was reported in this outcome measure. Analysis was performed using MMRM with treatment, time, strata (females versus males) and treatment-by-time interaction as fixed effects, natural log-transformed baseline as a covariate and the (natural log-transformed baseline)-by-time interaction with time fitted as a repeated effect and participant as a random effect. Values were back-transformed from the log scale. Percent change = 100 multiply by [*](back-transformed LS Mean minus [-] 1). Baseline was defined as the average of the duplicate measurements collected closest prior to dosing at Day 1.
Measured: Baseline, Week 26
Cohort 3: Percent Change From Baseline in Body Weight at End of Treatment at Week 32
Percent change from baseline in body weight at end of treatment was reported in this outcome measure. Analysis was performed using MMRM with treatment, time, strata (females versus males) and treatment-by-time interaction as fixed effects, natural log-transformed baseline as a covariate and the (natural log-transformed baseline)-by-time interaction with time fitted as a repeated effect and participant as a random effect. Values were back-transformed from the log scale. Percent change = 100*(back-transformed LS Mean - 1). Baseline was defined as the average of the duplicate measurements collected closest prior to dosing at Day 1.
Measured: Baseline, Week 32
Secondary outcomes (24)
Cohorts 1 and 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious AEs (TESAEs)
An adverse event (AE) was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose met one or more of the criteria such as resulted in death; life threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent disability or incapacity, congenital anomaly or birth defect; suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. An adverse event is considered treatment-emergent relative to given treatment if the event starts during the effective duration of the treatment (i.e. starting on or after the first dose but before the last dose plus follow-up period).
Measured: From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to 31 weeks)
Cohort 3: Number of Participants With TEAEs and TESAEs
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose met one or more of the criteria such as resulted in death; life threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent disability or incapacity, congenital anomaly or birth defect; suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. An adverse event is considered treatment-emergent relative to given treatment if the event starts during the effective duration of the treatment (i.e. starting on or after the first dose but before the last dose plus lag time).
Measured: From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to 37 weeks)
Cohorts 1 and 2: Number of Participants With Laboratory Abnormalities, Without Regard to Baseline Abnormality
Laboratory parameters:a)hematology:hemoglobin(Hg),hematocrit,erythrocytes(ery),neutrophils,ery mean corpuscular volume,platelets,leukocytes(leu),lymphocytes,basophils,eosinophils,monocytes activated partial thromboplastin time, prothrombin time,prothrombin initial normalised ratio b)chemistry:direct bilirubin(bil),indirect bil, gamma glutamyl transferase,urea nitrogen,urate,sodium,potassium,calcium(cal),cal corrected,bicarbonate,Hg a1c,creatine kinase,bile acid,calcitonin,insulin-fasting,glucose fasting,amylase,lipase,thyrotropin,thyroxine,free,cholesterol,high density lipoprotein (hdl) cholesterol,triglycerides,alanine aminotransferase c)urinalysis:urine:pH,ketone,protein, Hg, urobilinogen,nitrite,leu esterase,ery,leu,tubular epithelial cells,squamous epithelial cells,granular casts,hyaline casts,uric acid crystals,calcium oxalate crystals,amorphous crystals,mucus,microscopic exam,spermatozoa,yeast budding,transitional epithelial cells,leu cell clumps;yeast hyphae.
Measured: From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (up to 31 weeks)
Cohort 3: Number of Participants With Laboratory Abnormalities, Without Regard to Baseline Abnormality
Laboratory parameters:a)hematology:hemoglobin(Hg),hematocrit,erythrocytes(ery),neutrophils,ery mean corpuscular volume,platelets,leukocytes(leu),lymphocytes,basophils,eosinophils,monocytes activated partial thromboplastin time, prothrombin time,prothrombin initial normalised ratio b)chemistry:direct bilirubin(bil),indirect bil, gamma glutamyl transferase,urea nitrogen,urate,sodium,potassium,calcium(cal),cal corrected,bicarbonate,Hg a1c,creatine kinase,bile acid,calcitonin,insulin-fasting,glucose fasting,amylase,lipase,thyrotropin,thyroxine,free,cholesterol,high density lipoprotein (hdl) cholesterol,triglycerides,alanine aminotransferase c)urinalysis:urine:pH,ketone,protein, Hg, urobilinogen,nitrite,leu esterase,ery,leu,tubular epithelial cells,squamous epithelial cells,granular casts,hyaline casts,uric acid crystals,calcium oxalate crystals,amorphous crystals,mucus,microscopic exam,spermatozoa,yeast budding,transitional epithelial cells,leu cell clumps;yeast hyphae.
Measured: From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (up to 37 weeks)
Cohorts 1 and 2: Number of Participants According to Categorization of Vital Signs Data
Vital signs of systolic blood pressure, diastolic blood pressure and pulse rate and were measured using an automated device with the participant in a supine position after five minutes of rest. This reports the number of participants that met the following pre-specified criteria: systolic blood pressure (SBP) <90 millimetres of mercury (mmHg), diastolic blood pressure (DBP) <50 mmHg, pulse rate (PR) <40 beats per minute, >120 beats per minute.
Measured: From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (up to 31 weeks)
Cohort 3: Number of Participants According to Categorization of Vital Signs Data
Vital signs of systolic blood pressure, diastolic blood pressure and pulse rate and were measured using an automated device with the participant in a supine position after five minutes of rest. This reports the number of participants that met the following pre-specified criteria: systolic blood pressure (SBP) <90 millimetres of mercury (mmHg), diastolic blood pressure (DBP) <50 mmHg, pulse rate (PR) <40 beats per minute, >120 beats per minute.
Measured: From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (up to 37 weeks)
Cohorts 1 and 2: Number of Participants According to Categorization of Electrocardiogram (ECG) Parameters
Standard 12-lead ECGs were measured with the participant in a supine position after at least five minutes of rest. This reports the number of participants that met the following pre-specified criteria for ECG: QRS interval >=140; PR interval >=300; QTCF interval >500.
Measured: From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (up to 31 weeks)
Cohort 3: Number of Participants According to Categorization of ECG Parameters
Standard 12-lead ECGs were measured with the participant in a supine position after at least five minutes of rest. This reports the number of participants that met the following pre-specified criteria for ECG: QRS interval >=140; PR interval >=300; QTCF interval >500.
Measured: From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (up to 37 weeks)
Cohorts 1 and 2: Number of Participants With Categorical Scores on Columbia-Suicide Severity Rating Scale (C-SSRS) Leading to Study Discontinuation
C-SSRS is an interview-based rating scale to assess suicidal ideation and behavior. Per protocol, any participant with a pre-specified score was required to be evaluated by a mental health professional and, if meeting pre-defined criteria, discontinued from the study.
Measured: Week 0 (Baseline), 2, 4, 6, 8, 10, 12, 16, 18, 22, 26, Follow-up (Week 31)
Cohort 3: Number of Participants With Categorical Scores on C-SSRS Leading to Study Discontinuation
C-SSRS is an interview-based rating scale to assess suicidal ideation and behavior. Per protocol, any participant with a pre-specified score was required to be evaluated by a mental health professional and, if meeting pre-defined criteria, discontinued from the study.
Measured: Week 0 (Baseline), 4, 8, 12, 16, 20, 24, 28, 32, Follow-up (Week 37)
Cohort 1 and 2: Number of Participants With Scores on the Patient Health Questionnaire-9 (PHQ-9) Leading to Study Discontinuation
PHQ-9 is a self-reported, nine-item scale for the assessment of depressive disorder. Per protocol, any participant with a pre-specified score was required to be evaluated by a mental health professional and, if meeting pre-defined criteria, discontinued from the study.
Measured: Week 0 (Baseline) , 2, 4, 6, 8, 10, 12, 16, 18, 22, 26, Follow-up (Week 31)
Cohort 3: Number of Participants With Scores on the PHQ-9 Leading to Study Discontinuation
PHQ-9 is a self-reported, nine-item scale for the assessment of depressive disorder. Per protocol, any participant with a pre-specified score was required to be evaluated by a mental health professional and, if meeting pre-defined criteria, discontinued from the study.
Measured: Week 0 (Baseline), 4, 8, 12, 16, 20, 24, 28, 32, Follow-up (Week 37)
Cohorts 1 and 2: Number of Participants With >= 5% Body Weight Loss at End of Treatment
Number of participants with >= 5% body weight loss at end of treatment were reported.
Measured: Week 26
Cohort 3: Number of Participants With >=5% Body Weight Loss at End of Treatment
Number of participants with >= 5% body weight loss at end of treatment were reported.
Measured: Week 32
Cohorts 1 and 2: Percent Change From Baseline in Body Weight at Weeks 2, 4, 6, 8, 10, 12,16, 18, 22
Percent change from baseline in body weight at end of treatment was reported in this outcome measure. Analysis was performed using MMRM with treatment, time, strata (females versus males) and treatment-by-time interaction as fixed effects, natural log-transformed baseline as a covariate and the (natural log-transformed baseline)-by-time interaction with time fitted as a repeated effect and participant as a random effect. Values were back-transformed from the log scale. Percent change = 100*(back-transformed LS Mean - 1). Baseline was defined as the average of the duplicate measurements collected closest prior to dosing at Day 1.
Measured: Baseline, Weeks 2, 4, 6, 8, 10, 12,16, 18, 22
Cohort 3: Percent Change From Baseline in Body Weight at Weeks 4, 8, 12, 16, 20, 24 and 28
Percent change from baseline in body weight at end of treatment was reported in this outcome measure. Analysis was performed using MMRM with treatment, time, strata (females versus males) and treatment-by-time interaction as fixed effects, natural log-transformed baseline as a covariate and the (natural log-transformed baseline)-by-time interaction with time fitted as a repeated effect and participant as a random effect. Values were back-transformed from the log scale. Percent change = 100*(back-transformed LS Mean - 1). Baseline was defined as the average of the duplicate measurements collected closest prior to dosing at Day 1.
Measured: Baseline, Weeks 4, 8, 12, 16, 20, 24 and 28
Cohorts 1 and 2: Absolute Change From Baseline in Waist Circumference at End of Treatment at Week 26
Absolute change from baseline in waist circumference were reported. Analysis was performed using MMRM model with treatment, time, strata (females versus males) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. Baseline was defined as the average of the duplicate measurements collected closest prior to dosing at Day 1.
Measured: Baseline, Week 26
Cohort 3: Absolute Change From Baseline in Waist Circumference at End of Treatment at Week 32
Absolute change from baseline in waist circumference were reported. Analysis was performed using MMRM model with treatment, time, strata (females versus males) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. Baseline was defined as the average of the duplicate measurements collected closest prior to dosing at Day 1.
Measured: Baseline, Week 32
Cohorts 1 and 2: Absolute Change From Baseline in Waist-to-hip Ratio at End of Treatment at Week 26
Absolute change from baseline in waist-to-hip ratio at end of treatment were reported. Analysis was performed using MMRM model with treatment, time, strata (females versus males) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. Baseline was defined as the average of the duplicate measurements collected closest prior to dosing at Day 1.
Measured: Baseline, Week 26
Cohort 3: Absolute Change From Baseline in Waist-to-hip Ratio at End of Treatment at Week 32
Absolute change from baseline in waist-to-hip ratio at end of treatment were reported. Analysis was performed using MMRM model with treatment, time, strata (females versus males) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. Baseline was defined as the average of the duplicate measurements collected closest prior to dosing at Day 1.
Measured: Baseline, Week 32
Cohorts 1 and 2: Absolute Change From Baseline in Percentage Hemoglobin A1c (HbA1c) at Weeks 16 and 26
Absolute change from baseline in HbA1c were reported. Analysis was performed using MMRM model with treatment, time, strata (females versus males) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. Baseline was defined as the average of the duplicate measurements collected closest prior to dosing at Day 1.
Measured: Baseline, Weeks 16 and 26
Cohort 3: Absolute Change From Baseline in Percentage HbA1c at Weeks 16, 24 and 32
Absolute change from baseline in HbA1c were reported. Analysis was performed using MMRM model with treatment, time, strata (females versus males) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. Baseline was defined as the average of the duplicate measurements collected closest prior to dosing at Day 1.
Measured: Baseline, Weeks 16, 24 and 32
Cohorts 1 and 2: Absolute Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 2, 4, 6, 8, 10, 12, 16, 18, 22, 26
Absolute change from baseline in FPG were reported. Analysis was performed using MMRM model with treatment, time, strata (females versus males) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. Baseline was defined as the average of the duplicate measurements collected closest prior to dosing at Day 1.
Measured: Baseline, Weeks 2, 4, 6, 8, 10, 12, 16, 18, 22, 26
Cohort 3: Absolute Change From Baseline in FPG at Weeks 4, 8, 12, 16, 20, 24, 28, 32
Absolute change from baseline in FPG were reported. Analysis was performed using MMRM model with treatment, time, strata (females versus males) and treatment-by-time interaction as fixed effects, baseline as a covariate and the baseline-by-time interaction with time fitted as a repeated effect and participant as a random effect. Baseline was defined as the average of the duplicate measurements collected closest prior to dosing at Day 1.
Measured: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start29 Jan 2021
- Primary completion13 Sep 2023
- Study completion11 Oct 2023
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 ObesityStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 628 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
- NCT04707313
- Sponsor's protocol ID
- C3421019
- Other IDs
- 2020-001312-19
- Status last verified
- Oct 2024
- First submitted
- 11 Jan 2021
- Last updated
- 5 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Publications
Buckeridge C, Cobain S, Bays HE, Matsuoka O, Fukushima Y, Halstead P, Tsamandouras N, Sherry N, Gorman DN, Saxena AR. Efficacy and safety of danuglipron (PF-06882961) in adults with obesity: A randomized, placebo-controlled, dose-ranging phase 2b study. Diabetes Obes Metab. 2025 Sep;27(9):4915-4926. doi: 10.1111/dom.16534. Epub 2025 Jun 20.
PubMed 40539310
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-06882961 ADMINISTRATION IN ADULTS WITH OBESITY
- ClinicalTrials.gov ID
- NCT04707313
- Acronym / sponsor ID
- C3421019
- Conditions
- Obesity
- Keywords
- Weight loss
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 628 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 29 Jan 2021 (actual)
- Primary completion
- 13 Sep 2023 (actual)
- Study completion
- 11 Oct 2023 (actual)
- First posted
- 13 Jan 2021 (actual)
- Results
- Posted 9 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-06882961) for the potential treatment of obesity. The study will compare the experiences of participants taking the study medicine (PF-06882961) to those of participants who take placebo (a look- alike substance that contains no active study medicine). The aim is to measure the body's response to the study medicine, including any changes in participants' body weight, waist and hip measurements, how well they tolerate the study medicine, and to measure levels of the study medicine in participants' blood.
This study is seeking participants who have obesity, who do not have diabetes and who have had a stable body weight and not participated in a formal weight loss program in the 90 days before the study. The study medicine or placebo will be taken as tablets by mouth 2 times a day (1 time in the morning and 1 time in the evening).
There are 3 groups of participants (called cohorts) in this study. For participants in Cohorts 1 and 2, total study participation will be about 9 months, with 15 planned study visits (14 visits to the study clinic and 1 telephone call). For participants in Cohort 3, total study participation will be about 10 months, with 21 planned study visits (12 visits to the study clinic and 9 telephone calls).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 13
| Arm | Type | Receives |
|---|---|---|
| Placebo (Cohorts 1 and 2) | Placebo comparator | Drug: Placebo (Cohorts 1 and 2) |
| PF-06882961 40 milligrams (mg) twice daily (BID), 1-week titration (Cohort 1) | Experimental | Drug: PF-06882961 (Cohorts 1 and 2)The dose will be titrated with 1 week of dosing at each step to reach the target dose of 40 mg BID. |
| PF-06882961 80 mg BID, 1-week titration (Cohort 1) | Experimental | Drug: PF-06882961 (Cohorts 1 and 2)The dose will be titrated with 1 week of dosing at each step to reach the target dose of 80 mg BID. |
| PF-06882961 120 mg BID, 1-week titration (Cohort 1) | Experimental | Drug: PF-06882961 (Cohorts 1 and 2)The dose will be titrated with 1 week of dosing at each step to reach the target dose of 120 mg BID. |
| PF-06882961 160 mg BID, 1-week titration (Cohort 1) | Experimental | Drug: PF-06882961 (Cohorts 1 and 2)The dose will be titrated with 1 week of dosing at each step to reach the target dose of 160 mg BID. |
| PF-06882961 200 mg BID, 1-week titration (Cohort 1) | Experimental | Drug: PF-06882961 (Cohorts 1 and 2)The dose will be titrated with 1 week of dosing at each step to reach the target dose of 200 mg BID. |
| PF-06882961 120 mg BID, 2-week titration (Cohorts 1 and 2) | Experimental | Drug: PF-06882961 (Cohorts 1 and 2)The dose will be titrated with 2 weeks of dosing at each step to reach the target dose of 120 mg BID. |
| PF-06882961 160 mg BID, 2-week titration (Cohorts 1 and 2) | Experimental | Drug: PF-06882961 (Cohorts 1 and 2)The dose will be titrated with 2 weeks of dosing at each step to reach the target dose of 160 mg BID. |
| PF-06882961 200 mg BID, 2-week titration (Cohorts 1 and 2) | Experimental | Drug: PF-06882961 (Cohorts 1 and 2)The dose will be titrated with 2 weeks of dosing at each step to reach the target dose of 200 mg BID. |
| Placebo (Cohort 3) | Placebo comparator | Drug: Placebo (Cohort 3) |
| PF-06882961 80 mg BID, 4-week titration (Cohort 3) | Experimental | Drug: PF-06882961 (Cohort 3)The dose will be titrated with 4 weeks of dosing at each step to reach the target dose of 80 mg BID. |
| PF-06882961 140 mg BID, 4-week titration (Cohort 3) | Experimental | Drug: PF-06882961 (Cohort 3)The dose will be titrated with 4 weeks of dosing at each step to reach the target dose of 140 mg BID. |
| PF-06882961 200 mg BID, 4-week titration (Cohort 3) | Experimental | Drug: PF-06882961 (Cohort 3)The dose will be titrated with 4 weeks of dosing at each step to reach the target dose of 200 mg BID. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants with obesity, defined as a Body Mass Index greater than or equal to 30.0 kg/m2
- Stable body weight, defined as <5 kg change (per participant report) for 90 days before visit 1
Key exclusion criteria (16 listed)
- Any condition possibly affecting drug absorption
- Current or prior diagnosis of Type 1 or Type 2 diabetes mellitus or secondary forms of diabetes
- History of myocardial infarction, unstable angina, arterial revascularization, stroke, heart failure, or transient ischemic attack within 6 months prior to visit 1
- Any malignancy not considered cured
- Personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 or suspected MTC
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 |
|---|---|---|
| Placebo (Cohorts 1 and 2)4 matching placebo tablets taken twice daily | Drug | Placebo (Cohorts 1 and 2) |
| PF-06882961 (Cohorts 1 and 2)Participants will be randomized to one of 5 active target dose levels (40, 80, 120, 160 or 200 mg BID) achieved through 1-week titration steps, or 3 active target dose levels (120, 160 or 200 mg BID) achieved through 2-week titration steps, taking 4 tablets twice daily | Drug | PF-06882961 120 mg BID, 1-week titration (Cohort 1), PF-06882961 120 mg BID, 2-week titration (Cohorts 1 and 2), PF-06882961 160 mg BID, 1-week titration (Cohort 1), PF-06882961 160 mg BID, 2-week titration (Cohorts 1 and 2), PF-06882961 200 mg BID, 1-week titration (Cohort 1), PF-06882961 200 mg BID, 2-week titration (Cohorts 1 and 2), PF-06882961 40 milligrams (mg) twice daily (BID), 1-week titration (Cohort 1), PF-06882961 80 mg BID, 1-week titration (Cohort 1) |
| Placebo (Cohort 3)2 matching placebo tablets taken twice daily | Drug | Placebo (Cohort 3) |
| PF-06882961 (Cohort 3)Participants will be randomized to one of 3 active target dose levels (80, 140 or 200 mg BID) achieved through 4-week titration steps, taking 2 tablets twice daily. | Drug | PF-06882961 140 mg BID, 4-week titration (Cohort 3), PF-06882961 200 mg BID, 4-week titration (Cohort 3), PF-06882961 80 mg BID, 4-week titration (Cohort 3) |
Primary outcome
Cohorts 1 and 2: Percent Change From Baseline in Body Weight at End of Treatment at Week 26
Time frame: Baseline, Week 26
Percent change from baseline in body weight at end of treatment was reported in this outcome measure. Analysis was performed using MMRM with treatment, time, strata (females versus males) and treatment-by-time interaction as fixed effects, natural log-transformed baseline as a covariate and the (natural log-transformed baseline)-by-time interaction with time fitted as a repeated effect and participant as a random effect. Values were back-transformed from the log scale. Percent change = 100 multiply by [*](back-transformed LS Mean minus [-] 1). Baseline was defined as the average of the duplicate measurements collected closest prior to dosing at Day 1.
Cohort 3: Percent Change From Baseline in Body Weight at End of Treatment at Week 32
Time frame: Baseline, Week 32
Percent change from baseline in body weight at end of treatment was reported in this outcome measure. Analysis was performed using MMRM with treatment, time, strata (females versus males) and treatment-by-time interaction as fixed effects, natural log-transformed baseline as a covariate and the (natural log-transformed baseline)-by-time interaction with time fitted as a repeated effect and participant as a random effect. Values were back-transformed from the log scale. Percent change = 100*(back-transformed LS Mean - 1). Baseline was defined as the average of the duplicate measurements collected closest prior to dosing at Day 1.
24 secondary outcomes
Cohorts 1 and 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious AEs (TESAEs)
Time frame: From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to 31 weeks)
Cohort 3: Number of Participants With TEAEs and TESAEs
Time frame: From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (maximum up to 37 weeks)
Cohorts 1 and 2: Number of Participants With Laboratory Abnormalities, Without Regard to Baseline Abnormality
Time frame: From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (up to 31 weeks)
Cohort 3: Number of Participants With Laboratory Abnormalities, Without Regard to Baseline Abnormality
Time frame: From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (up to 37 weeks)
Cohorts 1 and 2: Number of Participants According to Categorization of Vital Signs Data
Time frame: From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (up to 31 weeks)
Cohort 3: Number of Participants According to Categorization of Vital Signs Data
Time frame: From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (up to 37 weeks)
Cohorts 1 and 2: Number of Participants According to Categorization of Electrocardiogram (ECG) Parameters
Time frame: From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (up to 31 weeks)
Cohort 3: Number of Participants According to Categorization of ECG Parameters
Time frame: From first dose of study intervention on Day 1 up to 28-35 days after last dose of study treatment (up to 37 weeks)
Cohorts 1 and 2: Number of Participants With Categorical Scores on Columbia-Suicide Severity Rating Scale (C-SSRS) Leading to Study Discontinuation
Time frame: Week 0 (Baseline), 2, 4, 6, 8, 10, 12, 16, 18, 22, 26, Follow-up (Week 31)
Cohort 3: Number of Participants With Categorical Scores on C-SSRS Leading to Study Discontinuation
Time frame: Week 0 (Baseline), 4, 8, 12, 16, 20, 24, 28, 32, Follow-up (Week 37)
Cohort 1 and 2: Number of Participants With Scores on the Patient Health Questionnaire-9 (PHQ-9) Leading to Study Discontinuation
Time frame: Week 0 (Baseline) , 2, 4, 6, 8, 10, 12, 16, 18, 22, 26, Follow-up (Week 31)
Cohort 3: Number of Participants With Scores on the PHQ-9 Leading to Study Discontinuation
Time frame: Week 0 (Baseline), 4, 8, 12, 16, 20, 24, 28, 32, Follow-up (Week 37)
Cohorts 1 and 2: Number of Participants With >= 5% Body Weight Loss at End of Treatment
Time frame: Week 26
Cohort 3: Number of Participants With >=5% Body Weight Loss at End of Treatment
Time frame: Week 32
Cohorts 1 and 2: Percent Change From Baseline in Body Weight at Weeks 2, 4, 6, 8, 10, 12,16, 18, 22
Time frame: Baseline, Weeks 2, 4, 6, 8, 10, 12,16, 18, 22
Cohort 3: Percent Change From Baseline in Body Weight at Weeks 4, 8, 12, 16, 20, 24 and 28
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24 and 28
Cohorts 1 and 2: Absolute Change From Baseline in Waist Circumference at End of Treatment at Week 26
Time frame: Baseline, Week 26
Cohort 3: Absolute Change From Baseline in Waist Circumference at End of Treatment at Week 32
Time frame: Baseline, Week 32
Cohorts 1 and 2: Absolute Change From Baseline in Waist-to-hip Ratio at End of Treatment at Week 26
Time frame: Baseline, Week 26
Cohort 3: Absolute Change From Baseline in Waist-to-hip Ratio at End of Treatment at Week 32
Time frame: Baseline, Week 32
Cohorts 1 and 2: Absolute Change From Baseline in Percentage Hemoglobin A1c (HbA1c) at Weeks 16 and 26
Time frame: Baseline, Weeks 16 and 26
Cohort 3: Absolute Change From Baseline in Percentage HbA1c at Weeks 16, 24 and 32
Time frame: Baseline, Weeks 16, 24 and 32
Cohorts 1 and 2: Absolute Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 2, 4, 6, 8, 10, 12, 16, 18, 22, 26
Time frame: Baseline, Weeks 2, 4, 6, 8, 10, 12, 16, 18, 22, 26
Cohort 3: Absolute Change From Baseline in FPG at Weeks 4, 8, 12, 16, 20, 24, 28, 32
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40539310Buckeridge C, Cobain S, Bays HE, Matsuoka O, Fukushima Y, Halstead P, Tsamandouras N, Sherry N, Gorman DN, Saxena AR. Efficacy and safety of danuglipron (PF-06882961) in adults with obesity: A randomized, placebo-controlled, dose-ranging phase 2b study. Diabetes Obes Metab. 2025 Sep;27(9):4915-4926. doi: 10.1111/dom.16534. Epub 2025 Jun 20.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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
41 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PF-06882961 (Cohorts 1 and 2) and PF-06882961 (Cohort 3) in people with Obesity, run by Pfizer at 41 sites in 4 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 2 inclusion and 16 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 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States, Canada, Japan, Taiwan. 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 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 9 Oct 2024). 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?
Cohorts 1 and 2: Percent Change From Baseline in Body Weight at End of Treatment at Week 26 (time frame: Baseline, Week 26). 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 NCT04707313, 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 5 Nov 2024.