A Phase 2b, Dose-range Finding Study of the Efficacy and Safety of Multiple Doses of Aleniglipron (GSBR-1290) in Participants Living With Obesity or Overweight With at Least One Weight-related Comorbidity

Last updated: August 20, 2025
Sponsor: Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics
Overall Status: Active - Not Recruiting

Phase

2

Condition

Obesity

Diabetes Prevention

Hypertriglyceridemia

Treatment

Aleniglipron or Placebo

Aleniglipron

GSBR-1290 or Placebo

Clinical Study ID

NCT06693843
GSBR-1290-06
  • Ages 18-79
  • All Genders

Study Summary

This study is a randomized, double-blind, placebo-controlled, dose-range finding study of the efficacy, safety, tolerability, PK, and PD of multiple doses of aleniglipron in participants living with overweight or obesity with at least one weight-related comorbidity. Participants will be randomized to aleniglipron or placebo in a ratio of 3:1 within each Cohort receiving multiple-ascending, QD doses of aleniglipron or placebo in titration steps of 4 weeks duration for a total of 36 weeks of treatment. At the end of the study (after completing 36 weeks of treatment), participants will be offered to continue with an open-label extension (OLE) where they will receive aleniglipron for an additional 36 weeks.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Signed informed consent

  • BMI ≥30 kg/m2 or BMI ≥27.0 kg/m2 and previous/current diagnosis of ≥ 1 obesityrelated comorbidity

Exclusion

Exclusion Criteria:

  • Previous documented diagnosis of diabetes mellitus.

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

  • Body weight ≤80 kg at Screening

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

Study Design

Total Participants: 220
Treatment Group(s): 3
Primary Treatment: Aleniglipron or Placebo
Phase: 2
Study Start date:
October 17, 2024
Estimated Completion Date:
August 31, 2026

Connect with a study center

  • ACCESS Research Site

    Phoenix, Arizona 85044
    United States

    Site Not Available

  • ACCESS Research Site

    Phoenix 5308655, Arizona 5551752 85044
    United States

    Site Not Available

  • ACCESS Research Site

    Anaheim, California 92801
    United States

    Site Not Available

  • ACCESS Research Site

    Los Angeles, California 90057
    United States

    Site Not Available

  • ACCESS Research Site

    Montclair, California 91763
    United States

    Site Not Available

  • ACCESS Research Site

    Rancho Cucamonga, California 91730
    United States

    Site Not Available

  • ACCESS Research Site

    Sacramento, California 95821
    United States

    Site Not Available

  • ACCESS Research Site

    Spring Valley, California 91978
    United States

    Site Not Available

  • ACCESS Research Site

    Anaheim 5323810, California 5332921 92801
    United States

    Site Not Available

  • ACCESS Research Site

    Los Angeles 5368361, California 5332921 90057
    United States

    Site Not Available

  • ACCESS Research Site

    Montclair 5374232, California 5332921 91763
    United States

    Site Not Available

  • ACCESS Research Site

    Rancho Cucamonga 5385955, California 5332921 91730
    United States

    Site Not Available

  • ACCESS Research Site

    Sacramento 5389489, California 5332921 95821
    United States

    Site Not Available

  • ACCESS Research Site

    Spring Valley 5398277, California 5332921 91978
    United States

    Site Not Available

  • ACCESS Research Site

    Honolulu, Hawaii 96814
    United States

    Site Not Available

  • ACCESS Research Site

    Honolulu 5856195, Hawaii 5855797 96814
    United States

    Site Not Available

  • ACCESS Research Site

    Chicago, Illinois 60602
    United States

    Site Not Available

  • ACCESS Research Site

    Evanston, Illinois 60201
    United States

    Site Not Available

  • ACCESS Research Site

    Chicago 4887398, Illinois 4896861 60637
    United States

    Site Not Available

  • ACCESS Research Site

    Evanston 4891382, Illinois 4896861 60201
    United States

    Site Not Available

  • ACCESS Research Site

    Muncie, Indiana 47304
    United States

    Site Not Available

  • ACCESS Research Site

    Valparaiso, Indiana 46383
    United States

    Site Not Available

  • ACCESS Research Site

    Muncie 4924006, Indiana 4921868 47304
    United States

    Site Not Available

  • ACCESS Research Site

    Valparaiso 4927537, Indiana 4921868 46383
    United States

    Site Not Available

  • ACCESS Research Site

    West Des Moines, Iowa 50265
    United States

    Site Not Available

  • ACCESS Research Site

    West Des Moines 4881346, Iowa 4862182 50265
    United States

    Site Not Available

  • ACCESS Research Site

    Baton Rouge, Louisiana 70808
    United States

    Site Not Available

  • GSBRClinicalTrials@structuretx.com

    Baton Rouge, Louisiana 70808
    United States

    Site Not Available

  • ACCESS Research Site

    Baton Rouge 4315588, Louisiana 4331987 70808
    United States

    Site Not Available

  • ACCESS Research Site

    Richfield, Minnesota 55423
    United States

    Site Not Available

  • ACCESS Research Site

    Richfield 5043193, Minnesota 5037779 55423
    United States

    Site Not Available

  • ACCESS Research Site

    Hazelwood, Missouri 63042
    United States

    Site Not Available

  • ACCESS Research Site

    Saint Peters, Missouri 63303
    United States

    Site Not Available

  • ACCESS Research Site

    Springfield, Missouri 65807
    United States

    Site Not Available

  • ACCESS Research Site

    City of Saint Peters 4407237, Missouri 4398678 63303
    United States

    Site Not Available

  • ACCESS Research Site

    Hazelwood 4389967, Missouri 4398678 63042
    United States

    Site Not Available

  • ACCESS Research Site

    Springfield 4409896, Missouri 4398678 65807
    United States

    Site Not Available

  • ACCESS Research Site

    Albany, New York 12203
    United States

    Site Not Available

  • ACCESS Research Site

    Binghamton, New York 13905
    United States

    Site Not Available

  • ACCESS Research Site

    Brooklyn, New York 10016
    United States

    Site Not Available

  • ACCESS Research Site

    Hartsdale, New York 10530
    United States

    Site Not Available

  • ACCESS Research Site

    Rochester, New York 14609
    United States

    Site Not Available

  • ACCESS Research Site

    Albany 5106834, New York 5128638 12203
    United States

    Site Not Available

  • ACCESS Research Site

    Binghamton 5109177, New York 5128638 13905
    United States

    Site Not Available

  • ACCESS Research Site

    Brooklyn 5110302, New York 5128638 10016
    United States

    Site Not Available

  • ACCESS Research Site

    Rochester 5134086, New York 5128638 14609
    United States

    Site Not Available

  • ACCESS Research Site

    Wilmington, North Carolina 28403
    United States

    Site Not Available

  • ACCESS Research Site

    Wilmington 4499379, North Carolina 4482348 28403
    United States

    Site Not Available

  • ACCESS Research Site

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • ACCESS Research Site

    Cincinnati 4508722, Ohio 5165418 45219
    United States

    Site Not Available

  • ACCESS Research Site

    Norman, Oklahoma 73069
    United States

    Site Not Available

  • ACCESS Research Site

    Norman 4543762, Oklahoma 4544379 73069
    United States

    Site Not Available

  • ACCESS Research Site

    Medford, Oregon 97504
    United States

    Site Not Available

  • ACCESS Research Site

    Medford 5740099, Oregon 5744337 97504
    United States

    Site Not Available

  • ACCESS Research Site

    Pittsburgh, Pennsylvania 15236
    United States

    Site Not Available

  • ACCESS Research Site

    Pittsburgh 5206379, Pennsylvania 6254927 15236
    United States

    Site Not Available

  • ACCESS Research Site

    Moncks Corner, South Carolina 29461
    United States

    Site Not Available

  • ACCESS Research Site

    Moncks Corner 4587511, South Carolina 4597040 29461
    United States

    Site Not Available

  • ACCESS Research Site

    Chattanooga, Tennessee 37421
    United States

    Site Not Available

  • ACCESS Research Site

    Chattanooga 4612862, Tennessee 4662168 37421
    United States

    Site Not Available

  • ACCESS Research Site

    Austin, Texas 78704
    United States

    Site Not Available

  • ACCESS Research Site

    Dallas, Texas 75226
    United States

    Site Not Available

  • ACCESS Research Site

    Mesquite, Texas 75149
    United States

    Site Not Available

  • ACCESS Research Site

    Shavano Park, Texas 78231
    United States

    Site Not Available

  • ACCESS Research Site

    Austin 4671654, Texas 4736286 78704
    United States

    Site Not Available

  • ACCESS Research Site

    Dallas 4684888, Texas 4736286 75243
    United States

    Site Not Available

  • ACCESS Research Site

    Mesquite 4710826, Texas 4736286 75149
    United States

    Site Not Available

  • ACCESS Research Site

    Shavano Park 4728147, Texas 4736286 78231
    United States

    Site Not Available

  • ACCESS Research Site

    West Jordan, Utah 84088
    United States

    Site Not Available

  • ACCESS Research Site

    West Jordan 5784549, Utah 5549030 84088
    United States

    Site Not Available

  • ACCESS Research Site

    Winchester, Virginia 22601
    United States

    Site Not Available

  • ACCESS Research Site

    Winchester 4794120, Virginia 6254928 22601
    United States

    Site Not Available

  • ACCESS Research Site

    Morgantown, West Virginia 26505
    United States

    Site Not Available

  • ACCESS Research Site

    Morgantown 4815352, West Virginia 4826850 26505
    United States

    Site Not Available

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