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RecruitingPhase 3

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

Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics · NCT07654361

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–79 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
3600
US sites recruiting
13
Study start
July 13, 2026
Record last updated
August 10, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the 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.

Being studied: Aleniglipron; Placebo

Conditions: Obesity; Overweight; Chronic Weight Management

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • ACCOMPLISH-1 Research Site

    Clearwater, FL 33756

    Site contact: Medical Director · GSBRClinicalTrials@structuretx.com

  • ACCOMPLISH-1 Research Site

    Honolulu, HI 96814-4526

    Site contact: Medical Director · GSBRClinicalTrials@structuretx.com

  • ACCOMPLISH-1 Research Site

    Silver Spring, MD 20901-4402

    Site contact: Medical Director · GSBRClinicalTrials@structuretx.com

  • ACCOMPLISH-1 Research Site

    Mankato, MN 56001

    Site contact: Medical Director · GSBRClinicalTrials@structuretx.com

  • ACCOMPLISH-1 Research Site

    Richfield, MN 55423

    Site contact: Medical Director · GSBRClinicalTrials@structuretx.com

  • ACCOMPLISH-1 Research Site

    Hazelwood, MO 63042

    Site contact: Medical Director · GSBRClinicalTrials@structuretx.com

  • ACCOMPLISH-1 Research Site

    St Louis, MO 63303-3041

    Site contact: Medical Director · GSBRClinicalTrials@structuretx.com

  • ACCOMPLISH-1 Research Site

    Charlotte, NC 28210

    Site contact: Medical Director · GSBRClinicalTrials@structuretx.com

  • ACCOMPLISH-1 Research Site

    Wilmington, NC 28401

    Site contact: Medical Director · GSBRClinicalTrials@structuretx.com

  • ACCOMPLISH-1 Research Site

    Columbus, OH 43215

    Site contact: Medical Director · GSBRClinicalTrials@structuretx.com

  • ACCOMPLISH-1 Research Site

    Portland, OR 97202

    Site contact: Medical Director · GSBRClinicalTrials@structuretx.com

  • ACCOMPLISH-1 Research Site

    Austin, TX 78731

    Site contact: Medical Director · GSBRClinicalTrials@structuretx.com

  • ACCOMPLISH-1 Research Site

    Renton, WA 98057

    Site contact: Medical Director · GSBRClinicalTrials@structuretx.com

Study contacts (from the official record)

  • Medical Director · 1-650-457-1959 · GSBRClinicalTrials@structuretx.com
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Efficacy and Safety of Aleniglipron in Participants With Obesity… (NCT07654361) | Bored Studies