PF-06882961 for Adults with Obesity: Safety and Efficacy
This phase 2 study aims to evaluate the safety and effectiveness of PF-06882961 in adults with obesity, specifically measuring the percent change in body weight from the start of the treatment to the end, at week 26 for cohorts 1 and 2, and week 32 for cohort 3.
Placebo (Cohorts 1 and 2)
+ PF-06882961 (Cohorts 1 and 2)
+ Placebo (Cohort 3)
Body Weight+7
+ Body Weight Changes
+ Nutrition Disorders
Treatment Study
Summary
Study start date: January 29, 2021
Actual date on which the first participant was enrolled.This clinical trial aims to understand the safety and effectiveness of a potential obesity treatment called PF-06882961. The study compares the experiences of participants who take the actual medicine with those who take a placebo, a look-alike substance with no active ingredients. The goal is to observe the body's response to the medicine, including changes in body weight, waist and hip measurements, and how well participants tolerate it. The study also measures the levels of the medicine in participants' blood. This study is designed for adults with obesity who do not have diabetes and have maintained a stable body weight without participating in a formal weight loss program in the 90 days before the study. Participants will take the study medicine or placebo as tablets, twice a day - once in the morning and once in the evening. The study has three groups of participants, known as cohorts. For those in Cohorts 1 and 2, participation will last about 9 months with 15 planned study visits, including 14 visits to the study clinic and 1 telephone call. For participants in Cohort 3, participation will last about 10 months with 21 planned study visits, including 12 visits to the study clinic and 9 telephone calls. The primary outcomes measured are the percent change from baseline in body weight at the end of treatment, which is at Week 26 for Cohorts 1 and 2, and at Week 32 for Cohort 3.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.628 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.13 intervention groups are designated in this study
15.385% chance of being blinded to the placebo group
Treatment Groups
Group I
PlaceboGroup II
ExperimentalGroup III
ExperimentalGroup IV
ExperimentalGroup 5
ExperimentalGroup 6
ExperimentalGroup 7
ExperimentalGroup 8
ExperimentalGroup 9
ExperimentalGroup 10
PlaceboGroup 11
ExperimentalGroup 12
ExperimentalGroup 13
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 41 locations
Anaheim Clinical Trials, LLC
Anaheim, United StatesVelocity Clinical Research - Westlake
Los Angeles, United StatesAlliance for Multispecialty Research, LLC
Coral Gables, United States