Aleniglipron Phase 2 Body Composition Study

Last updated: October 29, 2025
Sponsor: Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics
Overall Status: Active - Not Recruiting

Phase

2

Condition

Diabetes Prevention

Obesity

Hypertriglyceridemia

Treatment

aleniglipron or placebo

Clinical Study ID

NCT07169942
GSBR-1290-16
  • Ages 18-79
  • All Genders

Study Summary

This is a randomized, double-blind, placebo-controlled study evaluating the effects of aleniglipron on body composition in participants living with obesity. Participants will be randomized to aleniglipron or placebo in a ratio of 5:1. Participants will receive multiple ascending QD doses of aleniglipron or placebo in titration steps of 4 weeks duration for a total of 40 weeks of treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Signed informed consent

  • Participants age ≥18 years and <80 years, with BMI ≥30 kg/m2

  • Screening HbA1c <6.5 %

Exclusion

Exclusion Criteria:

  • Previous documented diagnosis of diabetes mellitus

  • Self-reported change in body weight >5% within 3 months before Screening

  • Have a body weight, height, and/or width that prohibits the ability to obtainaccurate measurements according to the DXA study specific manual that allowshemi-scan

  • Have a prior or planned surgical treatment for obesity (excluding liposuction orabdominoplasty, if performed >1 year prior to screening)

  • Have obesity induced by other endocrine disorders (such as Cushing's syndrome,Prader-Willi syndrome, or melanocortin 4 receptor deficiency)

Study Design

Total Participants: 71
Treatment Group(s): 1
Primary Treatment: aleniglipron or placebo
Phase: 2
Study Start date:
August 15, 2025
Estimated Completion Date:
September 30, 2026

Connect with a study center

  • Research Site

    Phoenix 5308655, Arizona 5551752 85020
    United States

    Site Not Available

  • Research Site

    Chicago 4887398, Illinois 4896861 60602
    United States

    Site Not Available

  • Research Site

    Richfield 5043193, Minnesota 5037779 55423
    United States

    Site Not Available

  • Research Site

    City of Saint Peters 4407237, Missouri 4398678 63303
    United States

    Site Not Available

  • Research Site

    Rochester 5134086, New York 5128638 14609
    United States

    Site Not Available

  • Research Site

    Wilmington 4499379, North Carolina 4482348 28401
    United States

    Site Not Available

  • Research Site

    Norman 4543762, Oklahoma 4544379 73069
    United States

    Site Not Available

  • Research Site

    Moncks Corner 4587511, South Carolina 4597040 29461
    United States

    Site Not Available

  • Research Site

    North Charleston 4589387, South Carolina 4597040 29405
    United States

    Site Not Available

  • Research Site

    Austin 4671654, Texas 4736286 78704
    United States

    Site Not Available

  • Research Site

    San Antonio 4726206, Texas 4736286 78240
    United States

    Site Not Available

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