A Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With Obesity
NCT ID: NCT04707313
Last Updated: 2024-11-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
628 participants
INTERVENTIONAL
2021-01-29
2023-10-11
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo (Cohorts 1 and 2)
Placebo (Cohorts 1 and 2)
4 matching placebo tablets taken twice daily
PF-06882961 40 milligrams (mg) twice daily (BID), 1-week titration (Cohort 1)
The dose will be titrated with 1 week of dosing at each step to reach the target dose of 40 mg BID.
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
PF-06882961 80 mg BID, 1-week titration (Cohort 1)
The dose will be titrated with 1 week of dosing at each step to reach the target dose of 80 mg BID.
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
PF-06882961 120 mg BID, 1-week titration (Cohort 1)
The dose will be titrated with 1 week of dosing at each step to reach the target dose of 120 mg BID.
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
PF-06882961 160 mg BID, 1-week titration (Cohort 1)
The dose will be titrated with 1 week of dosing at each step to reach the target dose of 160 mg BID.
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
PF-06882961 200 mg BID, 1-week titration (Cohort 1)
The dose will be titrated with 1 week of dosing at each step to reach the target dose of 200 mg BID.
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
PF-06882961 120 mg BID, 2-week titration (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 (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
PF-06882961 160 mg BID, 2-week titration (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 (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
PF-06882961 200 mg BID, 2-week titration (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.
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
Placebo (Cohort 3)
Placebo (Cohort 3)
2 matching placebo tablets taken twice daily
PF-06882961 80 mg BID, 4-week titration (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 (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.
PF-06882961 140 mg BID, 4-week titration (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 (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.
PF-06882961 200 mg BID, 4-week titration (Cohort 3)
The dose will be titrated with 4 weeks of dosing at each step to reach the target dose of 200 mg BID.
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.
Interventions
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Placebo (Cohorts 1 and 2)
4 matching placebo tablets taken twice daily
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
Placebo (Cohort 3)
2 matching placebo tablets taken twice daily
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.
Eligibility Criteria
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Inclusion Criteria
* Stable body weight, defined as \<5 kg change (per participant report) for 90 days before visit 1
Exclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pinnacle Research Group, LLC
Anniston, Alabama, United States
Anaheim Clinical Trials, LLC
Anaheim, California, United States
Velocity Clinical Research - Westlake
Los Angeles, California, United States
Alliance for Multispecialty Research, LLC
Coral Gables, Florida, United States
Optimus U Corporation
Miami, Florida, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States
ForCare Clinical Research
Tampa, Florida, United States
Clinical Investigation Specialists
Gurnee, Illinois, United States
MediSphere Medical Research Center, LLC
Evansville, Indiana, United States
Velocity Clinical Research, Valparaiso
Valparaiso, Indiana, United States
Cotton O'Neil Clinical Research Center
Topeka, Kansas, United States
L-MARC Research Center
Louisville, Kentucky, United States
ActivMed Practices & Research, LLC
Methuen, Massachusetts, United States
Velocity Clinical Research, Omaha
Omaha, Nebraska, United States
PMG Research of Hickory, LLC
Hickory, North Carolina, United States
PMG Research of Raleigh, LLC
Raleigh, North Carolina, United States
PMG Research of Salisbury, LLC
Salisbury, North Carolina, United States
Accellacare - Wilmington
Wilmington, North Carolina, United States
Lillestol Research LLC
Fargo, North Dakota, United States
Velocity Clinical Research, Inc.
Cleveland, Ohio, United States
Clinical Trials of South Carolina
Moncks Corner, South Carolina, United States
Coastal Carolina Research Center
North Charleston, South Carolina, United States
Palmetto Clinical Research
Summerville, South Carolina, United States
Palmetto Primary Care Physicians (Sub-I physicals only)
Summerville, South Carolina, United States
Internal Medicine and Pediatric Associates of Bristol, PC
Bristol, Tennessee, United States
PMG Research, Inc. d/b/a PMG Research of Knoxville
Knoxville, Tennessee, United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, United States
Rivergrove Medical Clinic
Winnipeg, Manitoba, Canada
Aggarwal and Associates Limited
Brampton, Ontario, Canada
Milestone Research , Inc
London, Ontario, Canada
Manna Research Toronto
Toronto, Ontario, Canada
Ecogene-21
Chicoutimi, Quebec, Canada
Alpha Recherche Clinique
Québec, Quebec, Canada
Diex Recherche Sherbrooke Inc.
Sherbrooke, Quebec, Canada
Centre de Recherche Saint-Louis
Québec, , Canada
Medical Corporation Heishinkai OCROM Clinic
Suita-shi, Osaka, Japan
Tokyo Center Clinic
Chuo-ku, Tokyo, Japan
Fukuwa Clinic
Chuo-ku, Tokyo, Japan
Medical Corporation Heishinkai ToCROM Clinic
Shinjuku-ku, Tokyo, Japan
China Medical University Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2020-001312-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C3421019
Identifier Type: -
Identifier Source: org_study_id
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