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🇺🇸 Albany, New York, United States
Medical DirectorContact
ACCOMPLISH-2 Research Site🇺🇸 Albany, New York, United States
Medical DirectorContact
ACCOMPLISH-2 Research Site🇺🇸 Atlanta, Georgia, United States
Medical DirectorContact
ACCOMPLISH-2 Research Site🇺🇸 Austin, Texas, United States
Medical DirectorContact
ACCOMPLISH-2 Research Site🇺🇸 Birmingham, Alabama, United States
Medical DirectorContact
ACCOMPLISH-2 Research Site🇺🇸 Brooklyn, New York, United States
Medical DirectorContact
ACCOMPLISH-2 Research Site🇺🇸 Burke, Virginia, United States
Medical DirectorContact
ACCOMPLISH-2 Research Site🇺🇸 Chandler, Arizona, United States
Medical DirectorContact
ACCOMPLISH-2 Research Site🇺🇸 Charlotte, North Carolina, United States
Medical DirectorContact
ACCOMPLISH-2 Research Site🇺🇸 Chesterfield, Missouri, United States
Medical DirectorContact
ACCOMPLISH-2 Research Site🇺🇸 City of Saint Peters, Missouri, United States
Medical DirectorContact
ACCOMPLISH-2 Research Site🇺🇸 Clearwater, Florida, United States
Medical DirectorContact
ACCOMPLISH-2 Research Site🇺🇸 Columbus, Georgia, United States
Medical DirectorContact
ACCOMPLISH-2 Research Site🇺🇸 Columbus, Ohio, United States
Medical DirectorContact
ACCOMPLISH-2 Research Site🇺🇸 Des Moines, Iowa, United States
Medical DirectorContact
ACCOMPLISH-2 Research Site🇺🇸 Durham, North Carolina, United States
Medical DirectorContact
ACCOMPLISH-2 Research Site🇺🇸 Escondido, California, United States
Medical DirectorContact
ACCOMPLISH-2 Research Site🇺🇸 Farmers Branch, Texas, United States
Medical DirectorContact
ACCOMPLISH-2 Research Site🇺🇸 Fayetteville, North Carolina, United States
Medical DirectorContact
ACCOMPLISH-2 Research Site🇺🇸 Fort Myers, Florida, United States
Medical DirectorContact
ACCOMPLISH-2 Research Site🇺🇸 Fountain Valley, California, United States
Medical DirectorContact
ACCOMPLISH-2 Research Site🇺🇸 Greer, South Carolina, United States
Medical DirectorContact
ACCOMPLISH-2 Research Site🇺🇸 Gulfport, Mississippi, United States
Medical DirectorContact
ACCOMPLISH-2 Research Site🇺🇸 Hazelwood, Missouri, United States
Medical DirectorContact
ACCOMPLISH-2 Research Site🇺🇸 Houston, Texas, United States
Medical DirectorContact
ACCOMPLISH-2 Research Site🇺🇸 Houston, Texas, United States
Medical DirectorContact
ACCOMPLISH-2 Research Site🇺🇸 Iowa City, Iowa, United States
Medical DirectorContact
ACCOMPLISH-2 Research Site🇺🇸 Jacksonville, Florida, United States
Medical DirectorContact
ACCOMPLISH-2 Research Site🇺🇸 La Jolla, California, United States
Medical DirectorContact
ACCOMPLISH-2 Research Site🇺🇸 Lake Forest, California, United States
Medical DirectorContact
ACCOMPLISH-2 Research Site🇺🇸 Las Vegas, Nevada, United States
Medical DirectorContact
ACCOMPLISH-2 Research Site🇺🇸 Lawrenceville, Georgia, United States
Medical DirectorContact
ACCOMPLISH-2 Research Site🇺🇸 Leesburg, Florida, United States
Medical DirectorContact
ACCOMPLISH-2 Research Site🇺🇸 Little Rock, Arkansas, United States
Medical DirectorContact
ACCOMPLISH-2 Research Site🇺🇸 Manassas, Virginia, United States
Medical DirectorContact
ACCOMPLISH-2 Research Site🇺🇸 Mankato, Minnesota, United States
Medical DirectorContact
ACCOMPLISH-2 Research Site🇺🇸 Meridian, Idaho, United States
Medical DirectorContact
ACCOMPLISH-2 Research Site🇺🇸 Methuen, Massachusetts, United States
Medical DirectorContact
ACCOMPLISH-2 Research Site🇺🇸 Miami, Florida, United States
Medical DirectorContact
ACCOMPLISH-2 Research Site🇺🇸 Minneapolis, Minnesota, United States
Medical DirectorContact