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A Study of Aleniglipron in Adults With Obesity or Overweight and Type 2 Diabetes Mellitus (ACCOMPLISH-2)

A Long-Term Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Multiple Maintenance Doses of Oral Once Daily Aleniglipron for Chronic Weight Management in Adults With Obesity or Overweight and Type 2 Diabetes Mellitus (ACCOMPLISH-2)

Who can join

Ages 18 to 79 · All sexes · Healthy volunteers welcome

Inclusion Criteria:

* Signed Informed Consent
* Have a BMI ≥27.0 kg/m2 at Screening
* Have a diagnosis of T2DM according to the WHO classification or other locally applicable standards, with HbA1c ≥6.5% (≥53 mmol/mol) to ≤10% (86 mmol/mol) at Screening

Exclusion Criteria:

* Have type 1 diabetes, history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2DM.
* Have had 1 or more episode of severe hypoglycemia and/or 1 or more episode of hypoglycemia unawareness within 180 days prior to Screening.
* Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema
* Self-reported change in body weight \>5 kg (11 pounds) within 3 months before Screening.
* Have prior or planned surgical or non-surgical treatment for obesity.

About the study

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.

What is being tested

• aleniglipron (drug)
• aleniglipron (drug)
• aleniglipron (drug)
• Placebo (drug)

Sponsor: Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics · Participants: 1,100 · Started: Jul 17, 2026

Contact the study team

• Medical Director · Phone: 1-650-457-1959

Official record on ClinicalTrials.gov — NCT07654374

Locations in the U.S.

Conditions

• Obesity
• Overweight

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.