A Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With Obesity

Completed · Phase 2 · Has a placebo group

Conditions studied: Obesity

In brief

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).

Key facts

Study ID

NCT04707313

Run by

Pfizer

People needed

628

Starts

2021-01-29

Expected to finish

2023-10-11

Last updated by the study team

2024-11-05

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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