Clinical trial
A Study of Aleniglipron in Adults With Obesity or Overweight and Type 2 Diabetes Mellitus (ACCOMPLISH-2)
Recruiting now · Phase 3 · 1 countries · Registry ID NCT07654374
Recruiting nowPhase 3Interventional
What this study is about
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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 79 Years
SexAll
Healthy volunteersAccepted
ConditionObesity, Overweight, Chronic Weight Management, Type2 Diabetes Mellitus
Full registry 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.
Treatments and study arms
aleniglipron
Drug
Drug: aleniglipron administered orally
aleniglipron
Drug
Drug: aleniglipron administered orally
aleniglipron
Drug
Drug: aleniglipron administered orally
Placebo
Drug
Drug: placebo administered orally
Primary outcomes
Percent change in body weight from BaselineBaseline and week 76
Study locations
74 locations were listed when this page was built. The first 40 are shown.
ACCOMPLISH-2 Research Site🇺🇸 Charlotte, North Carolina, United States
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ACCOMPLISH-2 Research Site🇺🇸 Chesterfield, Missouri, United States
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ACCOMPLISH-2 Research Site🇺🇸 City of Saint Peters, Missouri, United States
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ACCOMPLISH-2 Research Site🇺🇸 Durham, North Carolina, United States
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ACCOMPLISH-2 Research Site🇺🇸 Escondido, California, United States
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ACCOMPLISH-2 Research Site🇺🇸 Farmers Branch, Texas, United States
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ACCOMPLISH-2 Research Site🇺🇸 Fayetteville, North Carolina, United States
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ACCOMPLISH-2 Research Site🇺🇸 Fountain Valley, California, United States
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ACCOMPLISH-2 Research Site🇺🇸 Greer, South Carolina, United States
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ACCOMPLISH-2 Research Site🇺🇸 Gulfport, Mississippi, United States
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ACCOMPLISH-2 Research Site🇺🇸 Jacksonville, Florida, United States
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ACCOMPLISH-2 Research Site🇺🇸 La Jolla, California, United States
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ACCOMPLISH-2 Research Site🇺🇸 Lake Forest, California, United States
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ACCOMPLISH-2 Research Site🇺🇸 Lawrenceville, Georgia, United States
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ACCOMPLISH-2 Research Site🇺🇸 Little Rock, Arkansas, United States
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ACCOMPLISH-2 Research Site🇺🇸 Methuen, Massachusetts, United States
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