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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics • ClinicalTrials.gov ID: NCT07654374

Registry updated: 2026-10-20
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Description

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.

Interventions

  • aleniglipron (Drug)
    Drug: aleniglipron administered orally
  • aleniglipron (Drug)
    Drug: aleniglipron administered orally
  • aleniglipron (Drug)
    Drug: aleniglipron administered orally
  • Placebo (Drug)
    Drug: placebo administered orally

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.

Conditions

Obesity Overweight Chronic Weight Management Type2 Diabetes Mellitus

Locations

  • ACCOMPLISH-2 Research Site — Birmingham, Alabama, United States
  • ACCOMPLISH-2 Research Site — Chandler, Arizona, United States
  • ACCOMPLISH-2 Research Site — Phoenix, Arizona, United States
  • ACCOMPLISH-2 Research Site — Sun City West, Arizona, United States
  • ACCOMPLISH-2 Research Site — Tucson, Arizona, United States
  • ACCOMPLISH-2 Research Site — Little Rock, Arkansas, United States
  • ACCOMPLISH-2 Research Site — Escondido, California, United States
  • ACCOMPLISH-2 Research Site — Fountain Valley, California, United States
  • ACCOMPLISH-2 Research Site — La Jolla, California, United States
  • ACCOMPLISH-2 Research Site — Lake Forest, California, United States
  • ACCOMPLISH-2 Research Site — Rolling Hills Estates, California, United States
  • ACCOMPLISH-2 Research Site — San Diego, California, United States
  • ACCOMPLISH-2 Research Site — Tustin, California, United States
  • ACCOMPLISH-2 Research Site — Waterbury, Connecticut, United States
  • ACCOMPLISH-2 Research Site — Clearwater, Florida, United States
  • ACCOMPLISH-2 Research Site — Fort Myers, Florida, United States
  • ACCOMPLISH-2 Research Site — Jacksonville, Florida, United States
  • ACCOMPLISH-2 Research Site — Leesburg, Florida, United States
  • ACCOMPLISH-2 Research Site — Miami, Florida, United States
  • ACCOMPLISH-2 Research Site — Ocala, Florida, United States
  • ACCOMPLISH-2 Research Site — Ocoee, Florida, United States
  • ACCOMPLISH-2 Research Site — Pembroke Pines, Florida, United States
  • ACCOMPLISH-2 Research Site — Atlanta, Georgia, United States
  • ACCOMPLISH-2 Research Site — Columbus, Georgia, United States
  • ACCOMPLISH-2 Research Site — Lawrenceville, Georgia, United States
  • ACCOMPLISH-2 Research Site — Union City, Georgia, United States
  • ACCOMPLISH-2 Research Site — Woodstock, Georgia, United States
  • ACCOMPLISH-2 Research Site — Meridian, Idaho, United States
  • ACCOMPLISH-2 Research Site — Des Moines, Iowa, United States
  • ACCOMPLISH-2 Research Site — Iowa City, Iowa, United States
  • ACCOMPLISH-2 Research Site — Wichita, Kansas, United States
  • ACCOMPLISH-2 Research Site — Silver Spring, Maryland, United States
  • ACCOMPLISH-2 Research Site — Methuen, Massachusetts, United States
  • ACCOMPLISH-2 Research Site — Mankato, Minnesota, United States
  • ACCOMPLISH-2 Research Site — Minneapolis, Minnesota, United States
  • ACCOMPLISH-2 Research Site — Gulfport, Mississippi, United States
  • ACCOMPLISH-2 Research Site — Ridgeland, Mississippi, United States
  • ACCOMPLISH-2 Research Site — Chesterfield, Missouri, United States
  • ACCOMPLISH-2 Research Site — City of Saint Peters, Missouri, United States
  • ACCOMPLISH-2 Research Site — Hazelwood, Missouri, United States
  • ACCOMPLISH-2 Research Site — Springfield, Missouri, United States
  • ACCOMPLISH-2 Research Site — St Louis, Missouri, United States
  • ACCOMPLISH-2 Research Site — Missoula, Montana, United States
  • ACCOMPLISH-2 Research Site — Omaha, Nebraska, United States
  • ACCOMPLISH-2 Research Site — Las Vegas, Nevada, United States
  • ACCOMPLISH-2 Research Site — Albany, New York, United States
  • ACCOMPLISH-2 Research Site — Albany, New York, United States
  • ACCOMPLISH-2 Research Site — Brooklyn, New York, United States
  • ACCOMPLISH-2 Research Site — The Bronx, New York, United States
  • ACCOMPLISH-2 Research Site — Charlotte, North Carolina, United States
  • ACCOMPLISH-2 Research Site — Durham, North Carolina, United States
  • ACCOMPLISH-2 Research Site — Fayetteville, North Carolina, United States
  • ACCOMPLISH-2 Research Site — Morehead City, North Carolina, United States
  • ACCOMPLISH-2 Research Site — Winston-Salem, North Carolina, United States
  • ACCOMPLISH-2 Research Site — Columbus, Ohio, United States
  • ACCOMPLISH-2 Research Site — Moore, Oklahoma, United States
  • ACCOMPLISH-2 Research Site — Tulsa, Oklahoma, United States
  • ACCOMPLISH-2 Research Site — Yukon, Oklahoma, United States
  • ACCOMPLISH-2 Research Site — Portland, Oregon, United States
  • ACCOMPLISH-2 Research Site — Philadelphia, Pennsylvania, United States
  • ACCOMPLISH-2 Research Site — Greer, South Carolina, United States
  • ACCOMPLISH-2 Research Site — Nashville, Tennessee, United States
  • ACCOMPLISH-2 Research Site — Austin, Texas, United States
  • ACCOMPLISH-2 Research Site — Farmers Branch, Texas, United States
  • ACCOMPLISH-2 Research Site — Houston, Texas, United States
  • ACCOMPLISH-2 Research Site — Houston, Texas, United States
  • ACCOMPLISH-2 Research Site — San Antonio, Texas, United States
  • ACCOMPLISH-2 Research Site — San Antonio, Texas, United States
  • ACCOMPLISH-2 Research Site — Wylie, Texas, United States
  • ACCOMPLISH-2 Research Site — Salt Lake City, Utah, United States
  • ACCOMPLISH-2 Research Site — Burke, Virginia, United States
  • ACCOMPLISH-2 Research Site — Manassas, Virginia, United States
  • ACCOMPLISH-2 Research Site — Suffolk, Virginia, United States
  • ACCOMPLISH-2 Research Site — Renton, Washington, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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