MedTrace Logo

Efficacy and Safety of Aleniglipron in Participants With Obesity or Overweight With a Weight-Related Comorbidity (ACCOMPLISH-1)

NCT07654361 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3600

Last updated 2026-08-10

No results posted yet for this study

Summary

Study GSBR-1290-12 is a Phase 3 pivotal, multicenter, global, randomized, placebo-controlled, double-blind study to investigate the long-term efficacy, safety, and tolerability of 3 maintenance doses of aleniglipron once daily (QD) compared with placebo, when used in combination with a reduced-calorie diet and increased physical activity. All participants will be randomized to at least 76 weeks of treatment to evaluate the effects on long term body weight changes, tolerability, and safety. In addition, the study will compare the effects between aleniglipron and placebo on blood pressure (BP), lipid parameters, patient-reported outcomes.

Conditions

Interventions

DRUG

Aleniglipron

Drug: aleniglipron administered orally Drug

DRUG

Placebo

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
No

Timeline & Regulatory

Start
2026-07-13
Primary Completion
2028-09-30
Completion
2028-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07654361 on ClinicalTrials.gov