NCT07654374 A Study of Aleniglipron in Adults With Obesity or Overweight and Type 2 Diabetes Mellitus (ACCOMPLISH-2)
| NCT ID | NCT07654374 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,100 participants |
| Start Date | 2026-07-17 |
| 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 1,100 participants in total. It began in 2026-07-17 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
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07654374 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 NCT07654374 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 1,100 participants.
Is NCT07654374 currently recruiting?
Yes, NCT07654374 is actively recruiting participants. Contact the research team at GSBRClinicalTrials@structuretx.com for enrollment information.
Where is the NCT07654374 trial being conducted?
This trial is being conducted at Birmingham, United States, Chandler, United States, Phoenix, United States, Sun City West, United States and 11 additional locations.
Who is sponsoring the NCT07654374 clinical trial?
NCT07654374 is sponsored by Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics. The trial plans to enroll 1,100 participants.
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