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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

NCT ID: NCT06693843

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-17

Study Completion Date

2026-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity, Overweight, or Chronic Weight Management

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Cohort 1

Participants will receive Aleniglipron or Placebo administered orally.

Group Type EXPERIMENTAL

Aleniglipron or Placebo

Intervention Type DRUG

Drug: Aleniglipron Administered orally Drug: Placebo Administered orally

Cohort 2

Participants will receive Aleniglipron or Placebo administered orally.

Group Type EXPERIMENTAL

Aleniglipron or Placebo

Intervention Type DRUG

Drug: Aleniglipron Administered orally Drug: Placebo Administered orally

Cohort 3

Participants will receive Aleniglipron or Placebo administered orally.

Group Type EXPERIMENTAL

Aleniglipron or Placebo

Intervention Type DRUG

Drug: Aleniglipron Administered orally Drug: Placebo Administered orally

Cohort 1 OLE

Participants will receive Aleniglipron administered orally

Group Type ACTIVE_COMPARATOR

Aleniglipron

Intervention Type DRUG

Drug: Aleniglipron Administered orally

Cohort 2 OLE

Participants will receive Aleniglipron administered orally

Group Type ACTIVE_COMPARATOR

Aleniglipron

Intervention Type DRUG

Drug: Aleniglipron Administered orally

Cohort 3 OLE

Participants will receive Aleniglipron administered orally

Group Type ACTIVE_COMPARATOR

Aleniglipron

Intervention Type DRUG

Drug: Aleniglipron Administered orally

Cohort 4 OLE

Participants will receive Aleniglipron administered orally

Group Type ACTIVE_COMPARATOR

Aleniglipron

Intervention Type DRUG

Drug: Aleniglipron Administered orally

Interventions

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Aleniglipron or Placebo

Drug: Aleniglipron Administered orally Drug: Placebo Administered orally

Intervention Type DRUG

Aleniglipron or Placebo

Drug: Aleniglipron Administered orally Drug: Placebo Administered orally

Intervention Type DRUG

Aleniglipron or Placebo

Drug: Aleniglipron Administered orally Drug: Placebo Administered orally

Intervention Type DRUG

Aleniglipron

Drug: Aleniglipron Administered orally

Intervention Type DRUG

Aleniglipron

Drug: Aleniglipron Administered orally

Intervention Type DRUG

Aleniglipron

Drug: Aleniglipron Administered orally

Intervention Type DRUG

Aleniglipron

Drug: Aleniglipron Administered orally

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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ACCESS Research Site

Phoenix, Arizona, United States

Site Status

ACCESS Research Site

Anaheim, California, United States

Site Status

ACCESS Research Site

Los Angeles, California, United States

Site Status

ACCESS Research Site

Montclair, California, United States

Site Status

ACCESS Research Site

Rancho Cucamonga, California, United States

Site Status

ACCESS Research Site

Sacramento, California, United States

Site Status

ACCESS Research Site

Spring Valley, California, United States

Site Status

ACCESS Research Site

Honolulu, Hawaii, United States

Site Status

ACCESS Research Site

Chicago, Illinois, United States

Site Status

ACCESS Research Site

Chicago, Illinois, United States

Site Status

ACCESS Research Site

Evanston, Illinois, United States

Site Status

ACCESS Research Site

Muncie, Indiana, United States

Site Status

ACCESS Research Site

Valparaiso, Indiana, United States

Site Status

ACCESS Research Site

West Des Moines, Iowa, United States

Site Status

ACCESS Research Site

Baton Rouge, Louisiana, United States

Site Status

ACCESS Research Site

Richfield, Minnesota, United States

Site Status

ACCESS Research Site

City of Saint Peters, Missouri, United States

Site Status

ACCESS Research Site

Hazelwood, Missouri, United States

Site Status

ACCESS Research Site

Springfield, Missouri, United States

Site Status

ACCESS Research Site

Albany, New York, United States

Site Status

ACCESS Research Site

Binghamton, New York, United States

Site Status

ACCESS Research Site

Brooklyn, New York, United States

Site Status

ACCESS Research Site

Rochester, New York, United States

Site Status

ACCESS Research Site

Wilmington, North Carolina, United States

Site Status

ACCESS Research Site

Cincinnati, Ohio, United States

Site Status

ACCESS Research Site

Norman, Oklahoma, United States

Site Status

ACCESS Research Site

Medford, Oregon, United States

Site Status

ACCESS Research Site

Pittsburgh, Pennsylvania, United States

Site Status

ACCESS Research Site

Moncks Corner, South Carolina, United States

Site Status

ACCESS Research Site

Chattanooga, Tennessee, United States

Site Status

ACCESS Research Site

Austin, Texas, United States

Site Status

ACCESS Research Site

Austin, Texas, United States

Site Status

ACCESS Research Site

Dallas, Texas, United States

Site Status

ACCESS Research Site

Dallas, Texas, United States

Site Status

ACCESS Research Site

Mesquite, Texas, United States

Site Status

ACCESS Research Site

Shavano Park, Texas, United States

Site Status

ACCESS Research Site

West Jordan, Utah, United States

Site Status

ACCESS Research Site

Winchester, Virginia, United States

Site Status

ACCESS Research Site

Morgantown, West Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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GSBR-1290-06

Identifier Type: -

Identifier Source: org_study_id