A Study of Aleniglipron in Adults With Obesity or Overweight and Type 2 Diabetes Mellitus (ACCOMPLISH-2)

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

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.

Conditions5

Interventions1

Locations74 sites

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