A Study of Aleniglipron in Adults With Obesity or Overweight and Type 2 Diabetes Mellitus (ACCOMPLISH-2)
NCT07654374 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1100
Last updated 2026-08-10
Summary
This is randomized, double-blind, placebo-controlled study of the long-term efficacy, safety, and tolerability of multiple doses of aleniglipron in participants living with overweight or obesity and T2DM. Participants will be randomized to aleniglipron or placebo for a total of 76 weeks of treatment.
Conditions
- Obesity
- Overweight
- Chronic Weight Management
- Type2 Diabetes Mellitus
Interventions
- DRUG
-
Drug: aleniglipron administered orally
- DRUG
-
Drug: aleniglipron administered orally
- DRUG
-
Drug: aleniglipron administered orally
- DRUG
-
Drug: placebo administered orally
Sponsors & Collaborators
-
Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 79 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-07-17
- Primary Completion
- 2028-09-30
- Completion
- 2028-11-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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