NCT07654361 Efficacy and Safety of Aleniglipron in Participants With Obesity or Overweight With a Weight-Related Comorbidity (ACCOMPLISH-1)
| NCT ID | NCT07654361 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 3,600 participants |
| Start Date | 2026-07-13 |
| Primary Completion | 2028-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 3,600 participants in total. It began in 2026-07-13 with a primary completion date of 2028-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Signed informed consent * BMI ≥30 kg/m2 (obese) or BMI ≥27 kg/m2 (overweight) and presence of ≥1 of the obesity related comorbidities. Exclusion Criteria: * 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. * Have obesity induced by other endocrine disorders. * Impaired renal function at Screening * Chronic malabsorption
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07654361 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 79 Years, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07654361 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 3,600 participants.
Is NCT07654361 currently recruiting?
Yes, NCT07654361 is actively recruiting participants. Contact the research team at GSBRClinicalTrials@structuretx.com for enrollment information.
Where is the NCT07654361 trial being conducted?
This trial is being conducted at Birmingham, United States, Birmingham, United States, Phoenix, United States, Sun City West, United States and 11 additional locations.
Who is sponsoring the NCT07654361 clinical trial?
NCT07654361 is sponsored by Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics. The trial plans to enroll 3,600 participants.
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