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

NCT06693843 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: GSBR-1290-06
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 39

Brief 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.

Conditions

Obesity, Overweight, or Chronic Weight Management

Keywords

ACCESS, obesity, overweight, GSBR-1290, aleniglipron, chronic weight management, obese, small molecule, GLP-1 receptor agonist, Structure Therapeutics

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (13)

• Percentage of participants who achieve ≥5% reduction in body weight at Week 36

  Baseline and week 36

• Percentage of participants who achieve ≥10% reduction in body weight at Week 36

  Baseline and week 36

• Percentage of participants who achieve ≥15% reduction in body weight at Week 36

  Baseline and week 36

• Change in body weight (absolute) from Baseline to Week 36

  Baseline and week 36

• Change in waist circumference from Baseline to Week 36

  Baseline and week 36

Study Arms (7)

Cohort 1

EXPERIMENTAL

Participants will receive Aleniglipron or Placebo administered orally.

Drug: Aleniglipron or Placebo

Cohort 2

EXPERIMENTAL

Participants will receive Aleniglipron or Placebo administered orally.

Drug: Aleniglipron or Placebo

Cohort 3

EXPERIMENTAL

Participants will receive Aleniglipron or Placebo administered orally.

Drug: Aleniglipron or Placebo

Cohort 1 OLE

ACTIVE COMPARATOR

Participants will receive Aleniglipron administered orally

Drug: Aleniglipron

Cohort 2 OLE

ACTIVE COMPARATOR

Participants will receive Aleniglipron administered orally

Drug: Aleniglipron

Cohort 3 OLE

ACTIVE COMPARATOR

Participants will receive Aleniglipron administered orally

Drug: Aleniglipron

Cohort 4 OLE

ACTIVE COMPARATOR

Participants will receive Aleniglipron administered orally

Drug: Aleniglipron

Interventions

Aleniglipron or Placebo DRUG

Drug: Aleniglipron Administered orally Drug: Placebo Administered orally

Cohort 1

Aleniglipron DRUG

Drug: Aleniglipron Administered orally

Cohort 1 OLE

Eligibility Criteria

• Age: 18 Years - 79 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (39)

ACCESS Research Site

Phoenix, Arizona, 85044, United States

Location

ACCESS Research Site

Anaheim, California, 92801, United States

Location

ACCESS Research Site

Los Angeles, California, 90057, United States

Location

ACCESS Research Site

Montclair, California, 91763, United States

Location

ACCESS Research Site

Rancho Cucamonga, California, 91730, United States

Location

ACCESS Research Site

Sacramento, California, 95821, United States

Location

ACCESS Research Site

Spring Valley, California, 91978, United States

Location

ACCESS Research Site

Honolulu, Hawaii, 96814, United States

Location

ACCESS Research Site

Chicago, Illinois, 60602, United States

Location

ACCESS Research Site

Chicago, Illinois, 60637, United States

Location

ACCESS Research Site

Evanston, Illinois, 60201, United States

Location

ACCESS Research Site

Muncie, Indiana, 47304, United States

Location

ACCESS Research Site

Valparaiso, Indiana, 46383, United States

Location

ACCESS Research Site

West Des Moines, Iowa, 50265, United States

Location

ACCESS Research Site

Baton Rouge, Louisiana, 70808, United States

Location

ACCESS Research Site

Richfield, Minnesota, 55423, United States

Location

ACCESS Research Site

City of Saint Peters, Missouri, 63303, United States

Location

ACCESS Research Site

Hazelwood, Missouri, 63042, United States

Location

ACCESS Research Site

Springfield, Missouri, 65807, United States

Location

ACCESS Research Site

Albany, New York, 12203, United States

Location

ACCESS Research Site

Binghamton, New York, 13905, United States

Location

ACCESS Research Site

Brooklyn, New York, 10016, United States

Location

ACCESS Research Site

Rochester, New York, 14609, United States

Location

ACCESS Research Site

Wilmington, North Carolina, 28403, United States

Location

ACCESS Research Site

Cincinnati, Ohio, 45219, United States

Location

ACCESS Research Site

Norman, Oklahoma, 73069, United States

Location

ACCESS Research Site

Medford, Oregon, 97504, United States

Location

ACCESS Research Site

Pittsburgh, Pennsylvania, 15236, United States

Location

ACCESS Research Site

Moncks Corner, South Carolina, 29461, United States

Location

ACCESS Research Site

Chattanooga, Tennessee, 37421, United States

Location

ACCESS Research Site

Austin, Texas, 78704, United States

Location

ACCESS Research Site

Austin, Texas, 78731, United States

Location

ACCESS Research Site

Dallas, Texas, 75226, United States

Location

ACCESS Research Site

Dallas, Texas, 75243, United States

Location

ACCESS Research Site

Mesquite, Texas, 75149, United States

Location

ACCESS Research Site

Shavano Park, Texas, 78231, United States

Location

ACCESS Research Site

West Jordan, Utah, 84088, United States

Location

ACCESS Research Site

Winchester, Virginia, 22601, United States

Location

ACCESS Research Site

Morgantown, West Virginia, 26505, United States

Location

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 18, 2024
• Study Start: October 28, 2024
• Primary Completion: October 24, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 28, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• 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.
• 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.

Locations

US (39)