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ACTIVE NOT RECRUITING
NCT06703021
PHASE2

A Dose-Range Study of Aleniglipron (GSBR-1290) in Participants Living With Obesity or Overweight With at Least One Weight-related Comorbidity

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

View on ClinicalTrials.gov

Summary

Phase 2 clinical study will evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of various aleniglipron (GSBR-1290) dose regimens compared with placebo in participants living with obesity or overweight with ≥ 1 weight-related comorbidity, in addition to diet and exercise, over a 44-week period.

Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Study of the Safety, Tolerability, and Efficacy of Increasing Optimal Doses of Aleniglipron (GSBR-1290) in Participants Living With Obesity (Body Mass Index ≥ 30 kg/m2) or Overweight (Body Mass Index ≥ 27 kg/m2) With at Least One Weight-related Comorbidity (ACCESS II)

Key Details

Gender

All

Age Range

18 Years - 79 Years

Study Type

INTERVENTIONAL

Enrollment

82

Start Date

2024-12-20

Completion Date

2025-12

Last Updated

2025-09-15

Healthy Volunteers

No

Interventions

DRUG

aleniglipron or placebo

Drug: aleniglipron administered orally; Drug: placebo administered orally

DRUG

aleniglipron or placebo

Drug: aleniglipron administered orally; Drug: placebo administered orally

DRUG

aleniglipron or placebo

Drug: aleniglipron administered orally; Drug: placebo administered orally

DRUG

aleniglipron or placebo

Drug: aleniglipron administered orally; Drug: placebo administered orally

Locations (10)

ACCESS II Research Site

Glendale, California, United States

ACCESS II Research Site

Montclair, California, United States

ACCESS II Research Site

Valparaiso, Indiana, United States

ACCESS II Research Site

West Des Moines, Iowa, United States

ACCESS II Research Site

Medford, Oregon, United States

ACCESS II Research Site

East Greenwich, Rhode Island, United States

ACCESS II Research Site

North Charleston, South Carolina, United States

ACCESS II Research Site

Dallas, Texas, United States

ACCESS II Research Site

San Antonio, Texas, United States

ACCESS II Research Site

West Jordan, Utah, United States