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

Registered clinical trial record on ClinicalTrials.gov (NCT07654374). This describes a planned, ongoing, or completed study — it is NOT peer-reviewed results. Status: not yet recruiting. Study type: interventional. Phase: Phase 3. Sponsor: Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics. Conditions: Obesity, Overweight, or Chronic Weight Management, T2DM. Interventions: aleniglipron, aleniglipron, aleniglipron, Placebo. 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. Primary outcome measures: Percent change in body weight from Baseline. Eligibility: 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.