NCT07654361RecruitingPhase 3
Efficacy and Safety of Aleniglipron in Participants With Obesity or Overweight With a Weight-Related Comorbidity (ACCOMPLISH-1)
A Randomized, Double-Blind, Placebo-Controlled, Pivotal Phase 3 Study to Evaluate the Long-Term Efficacy and Safety of Multiple Maintenance Doses of Once Daily Oral Aleniglipron for Chronic Weight Management in Adults With Obesity or Overweight and a Weight-Related Comorbidity
Source: ClinicalTrials.gov · Last updated 10 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 3600 (estimated)
- First submitted
- 12 Jun 2026
- Start date
- 13 Jul 2026
- Primary completion date
- Sept 2028
- Lead sponsor
- Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics
- Diseases
- Obesity
- NCT number
- NCT07654361
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 3600
- From 13 Jul 2026 to the primary completion date, Sept 2028
- 66 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previously documented diagnosis of type 1 diabetes, type 2 diabetes, or any other type of diabetes.
- Self-reported change in body weight \>5 kg within 3 months before Screening.
- Have prior or planned surgical or non-surgical treatment for obesity.
- Have or plan to have endoscopic and/or device-based therapy for obesity.
Other illness
- Have obesity induced by other endocrine disorders.
Other
- Impaired renal function at Screening
- Chronic malabsorption
Who the study is looking for
- Signed informed consent
- BMI ≥30 kg/m2 (obese) or BMI ≥27 kg/m2 (overweight) and presence of ≥1 of the obesity related comorbidities.
Age in the registry: 18 years to 79 years · Sex: All · Does not accept healthy volunteers
Sites (66)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.