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A Study of Aleniglipron in Adults With Obesity or Overweight and Type 2 Diabetes Mellitus (ACCOMPLISH-2)
NCT07654374 · Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics
In plain English
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Official title
A Long-Term Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Multiple Maintenance Doses of Oral Once Daily Aleniglipron for Chronic Weight Management in Adults With Obesity or Overweight and Type 2 Diabetes Mellitus (ACCOMPLISH-2)
About this study
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 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.
Study design
Enrollment target: 1100 participants
Allocation: randomized
Masking: triple
Age groups: adult, older_adult
Timeline
Starts: 2026-07-17
Estimated completion: 2028-11
Last updated: 2026-09-11
Interventions
Drug: aleniglipronDrug: aleniglipronDrug: aleniglipronDrug: Placebo
Primary outcomes
- • Percent change in body weight from Baseline (Baseline and week 76)
Sponsor
Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics · industry
Contacts & investigators
ContactMedical Director · contact · GSBRClinicalTrials@structuretx.com · 1-650-457-1959
All locations (74)
ACCOMPLISH-2 Research SiteRecruiting
Birmingham, Alabama, United States
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Chandler, Arizona, United States
ACCOMPLISH-2 Research SiteNot Yet Recruiting
Phoenix, Arizona, United States
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Sun City West, Arizona, United States
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Tucson, Arizona, United States
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Little Rock, Arkansas, United States
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Escondido, California, United States
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Fountain Valley, California, United States
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La Jolla, California, United States
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Lake Forest, California, United States
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Rolling Hills Estates, California, United States
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San Diego, California, United States
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Tustin, California, United States
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Waterbury, Connecticut, United States
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Clearwater, Florida, United States
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Fort Myers, Florida, United States
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Jacksonville, Florida, United States
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Leesburg, Florida, United States
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Miami, Florida, United States
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Ocala, Florida, United States
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Ocoee, Florida, United States
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Pembroke Pines, Florida, United States
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Atlanta, Georgia, United States
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Columbus, Georgia, United States
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Lawrenceville, Georgia, United States
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Union City, Georgia, United States
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Woodstock, Georgia, United States
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Meridian, Idaho, United States
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Des Moines, Iowa, United States
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Iowa City, Iowa, United States
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Wichita, Kansas, United States
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Silver Spring, Maryland, United States
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Methuen, Massachusetts, United States
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Mankato, Minnesota, United States
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Minneapolis, Minnesota, United States
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Gulfport, Mississippi, United States
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Ridgeland, Mississippi, United States
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Chesterfield, Missouri, United States
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City of Saint Peters, Missouri, United States
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Hazelwood, Missouri, United States
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Springfield, Missouri, United States
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St Louis, Missouri, United States
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Missoula, Montana, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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Albany, New York, United States
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Albany, New York, United States
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Brooklyn, New York, United States
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The Bronx, New York, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Fayetteville, North Carolina, United States
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Morehead City, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Columbus, Ohio, United States
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Moore, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Yukon, Oklahoma, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Greer, South Carolina, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Farmers Branch, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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Wylie, Texas, United States
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Salt Lake City, Utah, United States
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Burke, Virginia, United States
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Manassas, Virginia, United States
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Suffolk, Virginia, United States
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Renton, Washington, United States