Aleniglipron for weight management in obesity or overweight with a related condition

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, multicenter, global, randomized, double-blind, placebo-controlled trial evaluating three maintenance doses of aleniglipron once daily for up to at least 76 weeks in adults with obesity or overweight and a weight-related comorbidity. Participants will follow a reduced-calorie diet and increased physical activity while receiving either aleniglipron or placebo to assess long-term changes in body weight, tolerability, and safety. The study will also examine effects on blood pressure, lipid parameters, and patient-reported outcomes. Eligible participants must have BMI ≥30 kg/m2 (or ≥27 kg/m2 with a comorbidity) and meet specific inclusion/exclusion criteria related to other illnesses and prior obesity treatments.

Why it matters

Who can join: the full rules

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

Where it's running

• ACCOMPLISH-1 Research Site
  Clearwater, Florida, United States Recruiting
• ACCOMPLISH-1 Research Site
  Honolulu, Hawaii, United States Recruiting
• ACCOMPLISH-1 Research Site
  Silver Spring, Maryland, United States Recruiting
• ACCOMPLISH-1 Research Site
  Mankato, Minnesota, United States Recruiting
• ACCOMPLISH-1 Research Site
  Richfield, Minnesota, United States Recruiting
• ACCOMPLISH-1 Research Site
  Hazelwood, Missouri, United States Recruiting

+21 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.