A Phase 2b, Dose-range Finding Study of the Efficacy and Safety of Multiple Doses of Aleniglipron (GSBR-1290) in Participants Living With Obesity or Overweight With at Least One Weight-related Comorbidity

Summary

This study is a randomized, double-blind, placebo-controlled, dose-range finding study of the efficacy, safety, tolerability, PK, and PD of multiple doses of aleniglipron in participants living with overweight or obesity with at least one weight-related comorbidity. Participants will be randomized to aleniglipron or placebo in a ratio of 3:1 within each Cohort receiving multiple-ascending, QD doses of aleniglipron or placebo in titration steps of 4 weeks duration for a total of 36 weeks of treatment. At the end of the study (after completing 36 weeks of treatment), participants will be offered to continue with an open-label extension (OLE) where they will receive aleniglipron for an additional 36 weeks.

Timeline

Start

2024-10-28

Primary completion

2025-10-24

Completion

2026-08

Outcome

Met primary endpoint

paper At week 36, the trial met its primary endpoint PMID 42249138 ↗

Publications

• Rosenstock J, Lingvay I, Ryan D, Jastreboff AM, Kushner R, Acosta A, Blevins TC, Choi M, Holmes FL, Smith T, Connery L, Li Y, Liu MK, Barth A, Butcher J, Civitarese A, Yue H, Coll B; ACCESS Trial Investigators. Oral small molecule GLP-1 receptor agonist aleniglipron in people with overweight or obesity: a randomized, double-blind, placebo-controlled phase 2b trial. Nat Med. 2026 Jun 5. doi: 10.1038/s41591-026-04476-6. Online ahead of print.

Drugs

Indications