Efficacy and Safety of Aleniglipron in Participants With Obesity or Overweight With a Weight-Related Comorbidity (ACCOMPLISH-1)
Recruiting
Phase 3
Interventional Study
Obesity
Overweight
Chronic Weight Management
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 79
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 3,600 (estimated)
- Sponsor
- Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics · Industry
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About This Trial
Study GSBR-1290-12 is a Phase 3 pivotal, multicenter, global, randomized, placebo-controlled, double-blind study to investigate the long-term efficacy, safety, and tolerability of 3 maintenance doses of aleniglipron once daily (QD) compared with placebo, when used in combination with a reduced-calorie diet and increased physical activity. All participants will be randomized to at least 76 weeks of…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Signed informed consent
* BMI ≥30 kg/m2 (obese) or BMI ≥27 kg/m2 (overweight) and presence of ≥1 of the obesity related comorbidities.
Exclusion Criteria:
* Previously documented diagnosis of type 1 diabetes, type 2 diabetes, or any other type of diabetes.
* Self-reported ch…
Contacts