Clinical trial

Efficacy and Safety of Aleniglipron in Participants With Obesity or Overweight With a Weight-Related Comorbidity (ACCOMPLISH-1)

Recruiting now · Phase 3 · 1 countries · Registry ID NCT07654361

Recruiting nowPhase 3Interventional

What this study is about

Study GSBR-1290-12 is a Phase 3 pivotal, multicenter, global, randomized, placebo-controlled, double-blind study to investigate the long-term efficacy, safety, and tolerability of 3 maintenance doses of aleniglipron once daily (QD) compared with placebo, when used in combination with a reduced-calorie diet and increased physical activity. All participants will be randomized to at least 76 weeks of treatment to evaluate the effects on long term body weight changes, tolerability, and safety. In addition, the study will compare the effects between aleniglipron and placebo on blood pressure (BP), lipid parameters, patient-reported outcomes.

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 volunteersNot accepted
ConditionObesity, Overweight, Chronic Weight Management

Full registry criteria

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

Treatments and study arms

Aleniglipron

Drug

Drug: aleniglipron administered orally Drug

Placebo

Drug

Drug: placebo administered orally

Primary outcomes

Percent change in body weight from BaselineBaseline and Week 76

Study locations

71 locations were listed when this page was built. The first 40 are shown.

ACCOMPLISH-1 Research Site🇺🇸 Albany, New York, United States
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ACCOMPLISH-1 Research Site🇺🇸 Ann Arbor, Michigan, United States
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ACCOMPLISH-1 Research Site🇺🇸 Austin, Texas, United States
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ACCOMPLISH-1 Research Site🇺🇸 Austin, Texas, United States
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ACCOMPLISH-1 Research Site🇺🇸 Baton Rouge, Louisiana, United States
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ACCOMPLISH-1 Research Site🇺🇸 Birmingham, Alabama, United States
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ACCOMPLISH-1 Research Site🇺🇸 Birmingham, Alabama, United States
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ACCOMPLISH-1 Research Site🇺🇸 Brooklyn, New York, United States
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ACCOMPLISH-1 Research Site🇺🇸 Buford, Georgia, United States
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ACCOMPLISH-1 Research Site🇺🇸 Butte, Montana, United States
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ACCOMPLISH-1 Research Site🇺🇸 Charlotte, North Carolina, United States
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ACCOMPLISH-1 Research Site🇺🇸 Chesterfield, Missouri, United States
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ACCOMPLISH-1 Research Site🇺🇸 Chicago, Illinois, United States
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ACCOMPLISH-1 Research Site🇺🇸 Clearwater, Florida, United States
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ACCOMPLISH-1 Research Site🇺🇸 Columbus, Georgia, United States
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ACCOMPLISH-1 Research Site🇺🇸 Columbus, Ohio, United States
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ACCOMPLISH-1 Research Site🇺🇸 Columbus, Ohio, United States
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ACCOMPLISH-1 Research Site🇺🇸 Denison, Texas, United States
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ACCOMPLISH-1 Research Site🇺🇸 Durham, North Carolina, United States
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ACCOMPLISH-1 Research Site🇺🇸 Escondido, California, United States
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ACCOMPLISH-1 Research Site🇺🇸 Fayetteville, North Carolina, United States
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ACCOMPLISH-1 Research Site🇺🇸 Gardena, California, United States
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ACCOMPLISH-1 Research Site🇺🇸 Greer, South Carolina, United States
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ACCOMPLISH-1 Research Site🇺🇸 Gulfport, Mississippi, United States
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ACCOMPLISH-1 Research Site🇺🇸 Hazelwood, Missouri, United States
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ACCOMPLISH-1 Research Site🇺🇸 Honolulu, Hawaii, United States
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ACCOMPLISH-1 Research Site🇺🇸 Houston, Texas, United States
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ACCOMPLISH-1 Research Site🇺🇸 Houston, Texas, United States
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ACCOMPLISH-1 Research Site🇺🇸 Iowa City, Iowa, United States
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ACCOMPLISH-1 Research Site🇺🇸 Knoxville, Tennessee, United States
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ACCOMPLISH-1 Research Site🇺🇸 La Jolla, California, United States
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ACCOMPLISH-1 Research Site🇺🇸 Las Vegas, Nevada, United States
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ACCOMPLISH-1 Research Site🇺🇸 Lawrenceville, Georgia, United States
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ACCOMPLISH-1 Research Site🇺🇸 Leesburg, Florida, United States
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ACCOMPLISH-1 Research Site🇺🇸 Louisville, Kentucky, United States
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ACCOMPLISH-1 Research Site🇺🇸 Mankato, Minnesota, United States
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ACCOMPLISH-1 Research Site🇺🇸 Meridian, Idaho, United States
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ACCOMPLISH-1 Research Site🇺🇸 Methuen, Massachusetts, United States
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ACCOMPLISH-1 Research Site🇺🇸 Miami, Florida, United States
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ACCOMPLISH-1 Research Site🇺🇸 Missoula, Montana, United States
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