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

Phase 3RecruitingNCT07654374

Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics1,100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

1,100

Conditions

Obesity Overweight Chronic Weight Management Type2 Diabetes Mellitus

Interventions

Drug: aleniglipron administered orally

aleniglipronDRUG

Drug: aleniglipron administered orally

aleniglipronDRUG

Drug: aleniglipron administered orally

PlaceboDRUG

Drug: placebo administered orally

Eligibility

Sex: ALLMin age: 18 YearsMax age: 79 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (74)

ACCOMPLISH-2 Research Site

Birmingham, Alabama, United States

RECRUITING

ACCOMPLISH-2 Research Site

Chandler, Arizona, United States

RECRUITING

ACCOMPLISH-2 Research Site

Phoenix, Arizona, United States

NOT_YET_RECRUITING

ACCOMPLISH-2 Research Site

Sun City West, Arizona, United States