Aleniglipron for adults with overweight/obesity and type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 3, randomized, double-blind, placebo-controlled study. Participants with overweight or obesity and type 2 diabetes will be assigned to aleniglipron or placebo for 76 weeks. The trial will evaluate multiple dosing regimens for safety, tolerability, and efficacy, comparing outcomes to placebo over the treatment period. Key eligibility includes BMI 27 or higher and HbA1c between 6.5% and 10%.

Why it matters

Who can join: the full rules

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.

Where it's running

• ACCOMPLISH-2 Research Site
  Birmingham, Alabama, United States Recruiting
• ACCOMPLISH-2 Research Site
  Chandler, Arizona, United States Recruiting
• ACCOMPLISH-2 Research Site
  Phoenix, Arizona, United States Recruiting
• ACCOMPLISH-2 Research Site
  Sun City West, Arizona, United States Recruiting
• ACCOMPLISH-2 Research Site
  Tucson, Arizona, United States Recruiting
• ACCOMPLISH-2 Research Site
  Fountain Valley, California, United States Recruiting

+24 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Medical Director
• Email: GSBRClinicalTrials@structuretx.com
• Phone: 1-650-457-1959

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.