Phase 3 Study to Evaluate Monthly Berobenatide Injections for Adults With Overweight or Obesity, Including Those With Type 2 Diabetes

What this Trial Is About

Researchers are studying the effects and safety of berobenatide PF-08653944 in adults with overweight or obesity, including some who may also have type 2 diabetes. The main goal is to compare how people receiving berobenatide fare compared to those receiving a placebo, assessing if the study medicine helps with weight loss and is safe to use. This is a Phase 3 interventional clinical trial sponsored by Pfizer. Participants will receive berobenatide or a matching placebo by injection under the skin in the belly area. The trial uses a randomized, double-blind, placebo-controlled design with multiple treatment arms. Treatment is given once monthly, and the study will last about 20 months, during which participants will attend approximately 15 in-person visits and 2 phone visits. During the study, participants will be monitored through regular visits that include assessments of body weight, waist circumference, blood pressure, blood tests, and questionnaires about quality of life and eating behavior. Researchers will track safety outcomes such as adverse events and changes in metabolic and inflammatory markers. The primary outcome is the percent change in body weight from the start of the study to week 72, with ongoing follow-up to assess the treatments effects and safety.

A Study to Learn About the Study Medicine Called Berobenatide (PF-08653944) in People With Overweight or Obesity