Recruiting

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

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.

ClinicalTrials.gov IDNCT07654374

PhasePHASE3

Enrollment1100

SponsorGasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics

Age18 Years – 79 Years

SexALL

I'm interested View official listing

Conditions studied

Obesity, Overweight, Chronic Weight Management, Type2 Diabetes Mellitus

About this study

Interventions

Drug: aleniglipron — Drug: aleniglipron administered orally
Drug: aleniglipron — Drug: aleniglipron administered orally
Drug: aleniglipron — Drug: aleniglipron administered orally
Drug: Placebo — Drug: placebo administered orally

Primary outcomes

Percent change in body weight from Baseline (Baseline and week 76)

Eligibility information

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.

Study locations

ACCOMPLISH-2 Research Site, Birmingham, Alabama 35242 United States
ACCOMPLISH-2 Research Site, Chandler, Arizona 85225 United States
ACCOMPLISH-2 Research Site, Phoenix, Arizona 85028 United States
ACCOMPLISH-2 Research Site, Sun City West, Arizona 85375 United States
ACCOMPLISH-2 Research Site, Tucson, Arizona 85741 United States
ACCOMPLISH-2 Research Site, Little Rock, Arkansas 72211 United States
ACCOMPLISH-2 Research Site, Escondido, California 92025 United States
ACCOMPLISH-2 Research Site, Fountain Valley, California 92708 United States
ACCOMPLISH-2 Research Site, La Jolla, California 92123 United States
ACCOMPLISH-2 Research Site, Lake Forest, California 92630 United States

Showing 10 of 74 reported sites. See the official listing for all locations.

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-14.