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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Obesity, Overweight, or Chronic Weight Management

In brief

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.

Key facts

Study ID

NCT06693843

Run by

Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics

People needed

220

Starts

2024-10-28

Expected to finish

2026-08-01

Last updated by the study team

2026-04-28

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent
• BMI ≥30 kg/m2 or BMI ≥27.0 kg/m2 and previous/current diagnosis of ≥ 1 obesity related comorbidity

You may not qualify if…

• Previous documented diagnosis of diabetes mellitus.
• Self-reported change in body weight >5% within 3 months before Screening
• Body weight ≤80 kg at Screening
• Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty, if performed >1 year prior to screening)

Where it is running

• ACCESS Research Site — Phoenix, Arizona, United States
• ACCESS Research Site — Anaheim, California, United States
• ACCESS Research Site — Los Angeles, California, United States
• ACCESS Research Site — Montclair, California, United States
• ACCESS Research Site — Rancho Cucamonga, California, United States
• ACCESS Research Site — Sacramento, California, United States
• ACCESS Research Site — Spring Valley, California, United States
• ACCESS Research Site — Honolulu, Hawaii, United States
• ACCESS Research Site — Chicago, Illinois, United States
• ACCESS Research Site — Chicago, Illinois, United States
• ACCESS Research Site — Evanston, Illinois, United States
• ACCESS Research Site — Muncie, Indiana, United States
• ACCESS Research Site — Valparaiso, Indiana, United States
• ACCESS Research Site — West Des Moines, Iowa, United States
• ACCESS Research Site — Baton Rouge, Louisiana, United States
• ACCESS Research Site — Richfield, Minnesota, United States
• ACCESS Research Site — City of Saint Peters, Missouri, United States
• ACCESS Research Site — Hazelwood, Missouri, United States
• ACCESS Research Site — Springfield, Missouri, United States
• ACCESS Research Site — Albany, New York, United States
• ACCESS Research Site — Binghamton, New York, United States
• ACCESS Research Site — Brooklyn, New York, United States
• ACCESS Research Site — Rochester, New York, United States
• ACCESS Research Site — Wilmington, North Carolina, United States
• ACCESS Research Site — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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