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 (ACCESS)

A Phase 2b, Randomized, Double-blind, Placebo-controlled, Dose-range Finding Study of the Efficacy and Safety of Multiple Doses of Aleniglipron (GSBR-1290) in Participants Living With Obesity (Body Mass Index ≥ 30 kg/m2) or Overweight (Body Mass Index ≥ 27 kg/m2) With at Least One Weight-related Comorbidity

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity, Overweight, or Chronic Weight Management
• Intervention / Treatment: Drug: Aleniglipron or Placebo; Drug: Aleniglipron

• Study Type: Interventional
• Enrollment (Estimated): 220
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85044
      • ACCESS Research Site
  • California
    • Anaheim, California, United States, 92801
      • ACCESS Research Site
    • Los Angeles, California, United States, 90057
      • ACCESS Research Site
    • Montclair, California, United States, 91763
      • ACCESS Research Site
    • Rancho Cucamonga, California, United States, 91730
      • ACCESS Research Site
    • Sacramento, California, United States, 95821
      • ACCESS Research Site
    • Spring Valley, California, United States, 91978
      • ACCESS Research Site
  • Hawaii
    • Honolulu, Hawaii, United States, 96814
      • ACCESS Research Site
  • Illinois
    • Chicago, Illinois, United States, 60602
      • ACCESS Research Site
    • Chicago, Illinois, United States, 60637
      • ACCESS Research Site
    • Evanston, Illinois, United States, 60201
      • ACCESS Research Site
  • Indiana
    • Muncie, Indiana, United States, 47304
      • ACCESS Research Site
    • Valparaiso, Indiana, United States, 46383
      • ACCESS Research Site
  • Iowa
    • West Des Moines, Iowa, United States, 50265
      • ACCESS Research Site
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • ACCESS Research Site
  • Minnesota
    • Richfield, Minnesota, United States, 55423
      • ACCESS Research Site
  • Missouri
    • City of Saint Peters, Missouri, United States, 63303
      • ACCESS Research Site
    • Hazelwood, Missouri, United States, 63042
      • ACCESS Research Site
    • Springfield, Missouri, United States, 65807
      • ACCESS Research Site
  • New York
    • Albany, New York, United States, 12203
      • ACCESS Research Site
    • Binghamton, New York, United States, 13905
      • ACCESS Research Site
    • Brooklyn, New York, United States, 10016
      • ACCESS Research Site
    • Rochester, New York, United States, 14609
      • ACCESS Research Site
  • North Carolina
    • Wilmington, North Carolina, United States, 28403
      • ACCESS Research Site
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • ACCESS Research Site
  • Oklahoma
    • Norman, Oklahoma, United States, 73069
      • ACCESS Research Site
  • Oregon
    • Medford, Oregon, United States, 97504
      • ACCESS Research Site
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15236
      • ACCESS Research Site
  • South Carolina
    • Moncks Corner, South Carolina, United States, 29461
      • ACCESS Research Site
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • ACCESS Research Site
  • Texas
    • Austin, Texas, United States, 78704
      • ACCESS Research Site
    • Austin, Texas, United States, 78731
      • ACCESS Research Site
    • Dallas, Texas, United States, 75226
      • ACCESS Research Site
    • Dallas, Texas, United States, 75243
      • ACCESS Research Site
    • Mesquite, Texas, United States, 75149
      • ACCESS Research Site
    • Shavano Park, Texas, United States, 78231
      • ACCESS Research Site
  • Utah
    • West Jordan, Utah, United States, 84088
      • ACCESS Research Site
  • Virginia
    • Winchester, Virginia, United States, 22601
      • ACCESS Research Site
  • West Virginia
    • Morgantown, West Virginia, United States, 26505
      • ACCESS Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Signed informed consent
• BMI ≥30 kg/m2 or BMI ≥27.0 kg/m2 and previous/current diagnosis of ≥ 1 obesity related comorbidity

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 or abdominoplasty, if performed >1 year prior to screening)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; Participants will receive Aleniglipron or Placebo administered orally.	Drug: Aleniglipron or Placebo; Drug: Aleniglipron Administered orally Drug: Placebo Administered orally
Experimental: Cohort 2; Participants will receive Aleniglipron or Placebo administered orally.	Drug: Aleniglipron or Placebo; Drug: Aleniglipron Administered orally Drug: Placebo Administered orally
Experimental: Cohort 3; Participants will receive Aleniglipron or Placebo administered orally.	Drug: Aleniglipron or Placebo; Drug: Aleniglipron Administered orally Drug: Placebo Administered orally
Active Comparator: Cohort 1 OLE; Participants will receive Aleniglipron administered orally	Drug: Aleniglipron; Drug: Aleniglipron Administered orally
Active Comparator: Cohort 2 OLE; Participants will receive Aleniglipron administered orally	Drug: Aleniglipron; Drug: Aleniglipron Administered orally
Active Comparator: Cohort 3 OLE; Participants will receive Aleniglipron administered orally	Drug: Aleniglipron; Drug: Aleniglipron Administered orally
Active Comparator: Cohort 4 OLE; Participants will receive Aleniglipron administered orally	Drug: Aleniglipron; Drug: Aleniglipron Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent change in body weight from Baseline to Week 36	Double Blind Period	Baseline and week 36
TEAEs and SAEs	Open -Label Extension	Baseline and week 72
AESI	Open -Label Extension	Baseline and week 72
Evaluate the safety and tolerability of participants with abnormal laboratory values, including hematology, serum chemistry, and coagulation	Open -Label Extension	Baseline and week 72
Evaluate long-term safety and tolerability of aleniglipron as measured through electrocardiograms (including, but not limited to, the measurements of ventricular HR, PR interval, QRS duration, QT interval, and QTcF)	Open -Label Extension	Baseline and week 72
Evaluate the safety and tolerability of participants with abnormal vital signs, including blood pressure, heart rate, and temperature	Open -Label Extension	Baseline and week 72

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants who achieve ≥5% reduction in body weight at Week 36	Double Blind Period	Baseline and week 36
Percentage of participants who achieve ≥10% reduction in body weight at Week 36	Double Blind Period	Baseline and week 36
Percentage of participants who achieve ≥15% reduction in body weight at Week 36	Double Blind Period	Baseline and week 36
Change in body weight (absolute) from Baseline to Week 36	Double Blind Period	Baseline and week 36
Change in waist circumference from Baseline to Week 36	Double Blind Period	Baseline and week 36
Change in body mass index from Baseline to Week 36	Double Blind Period	Baseline and week 36
Percent change in body weight	Open -Label Extension	Baseline to week 72 & Week 36-72
Percentage of participants who achieve ≥5% reduction in body weight	Open -Label Extension	Baseline to week 72 & Week 36-72
Percentage of participants who achieve ≥10% reduction in body weight	Open -Label Extension	Baseline to week 72 & Week 36-72
Percentage of participants who achieve ≥15% reduction in body weight	Open -Label Extension	Baseline to week 72 & Week 36-72
Change in body weight	Open -Label Extension	Baseline to week 72 & Week 36-72
Change in body mass	Open -Label Extension	Baseline to week 72 & Week 36-72
Change in waist circumference	Open -Label Extension	Baseline to week 72 & Week 36-72

Other Outcome Measures

Outcome Measure	Time Frame
Open-label extension: Percent weight loss from Baseline up to 72 weeks	Baseline and week 72

Collaborators and Investigators

• Sponsor: Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2024
• Primary Completion (Actual): October 24, 2025
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: November 15, 2024
• First Submitted That Met QC Criteria: November 15, 2024
• First Posted (Actual): November 18, 2024

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: ACCESS, obesity, overweight, GSBR-1290, aleniglipron, chronic weight management, obese, small molecule, GLP-1 receptor agonist, Structure Therapeutics
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: GSBR-1290-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual patient data for variables necessary to address a specific research question in an approved data sharing request
• IPD Sharing Time Frame: Data sharing requests will be considered beginning 36 months after the study publication (manuscript accepted for publication) and either 1) the product has been granted marketing authorization in at least two regulatory jurisdictions, or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.

IPD Sharing Access Criteria

Researchers will submit a request containing the research objectives, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). Gasherbrum Bio, Inc. does not grant external requests for individual de-identified patient data for the following purposes:

• re-evaluating safety and efficacy end points already addressed in the product labelling,
• assessing safety or efficacy for an indication in current development

Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a panel of external advisors. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No