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

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 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).

Timeline

Start

2021-01-29

Primary completion

2023-09-13

Completion

2023-10-11

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.

Drugs

Indications