Trial to Learn About the Study Medicine (PF-07081532) and Rybelsus in People With Type 2 Diabetes and Separately PF-07081532 in People With Obesity

Summary

The purpose of this study is to find out if PF-07081532 ("the active study drug"), is safe and helps treat people with obesity without diabetes to lose weight, and people with diabetes to keep their blood sugar in good control. Individuals diagnosed with diabetes that are on metformin or individuals with obesity without diabetes will be included in the study. Those participating in the diabetes part of the study, will receive either active study drug, placebo, or an approved treatment called Rybelsus. Those in the obesity part of the study, will receive either active study drug or placebo. The study will last for about 36 weeks except for the first 25% of the participants that enter in which case the study will last for approximately 48 weeks. during this time there will be visits every 4 weeks with phone calls in between.

Timeline

Start

2022-10-27

Primary completion

2023-07-14

Completion

2023-09-22

Publications

• Kokkorakis M, Chakhtoura M, Rhayem C, Al Rifai J, Ghezzawi M, Valenzuela-Vallejo L, Mantzoros CS. Emerging pharmacotherapies for obesity: A systematic review. Pharmacol Rev. 2025 Jan;77(1):100002. doi: 10.1124/pharmrev.123.001045. Epub 2024 Nov 22.
• Amin NB, Frederich R, Tsamandouras N, Haggag AZ, Schuster T, Zmuda W, Palmer A, Vasas S, Buckley G, Smith TR, DuBrava SJ, Zhu Q, Johnson M. Evaluation of an oral small-molecule glucagon-like peptide-1 receptor agonist, lotiglipron, for type 2 diabetes and obesity: A dose-ranging, phase 2, randomized, placebo-controlled study. Diabetes Obes Metab. 2025 Jan;27(1):215-227. doi: 10.1111/dom.16005. Epub 2024 Oct 16.

Drugs

Indications