A Dose-Range Study of Aleniglipron (GSBR-1290) in Participants Living With Obesity or Overweight With at Least One Weight-related Comorbidity

NCT ID: NCT06703021

Last Updated: 2025-09-15

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

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-20

Study Completion Date

2025-12-31

Brief Summary

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Phase 2 clinical study will evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of various aleniglipron (GSBR-1290) dose regimens compared with placebo in participants living with obesity or overweight with ≥ 1 weight-related comorbidity, in addition to diet and exercise, over a 44-week period.

Detailed Description

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Conditions

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Obesity Overweight Chronic Weight Management

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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Sentinel

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 1a

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 1b

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 1c

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

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 or placebo

Drug: aleniglipron administered orally; Drug: placebo 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
* Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty, if performed \>1 year prior to screening)
* Use of medications intended to promote weight loss, within 6 months 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 II Research Site

Glendale, California, United States

Site Status

ACCESS II Research Site

Montclair, California, United States

Site Status

ACCESS II Research Site

Valparaiso, Indiana, United States

Site Status

ACCESS II Research Site

West Des Moines, Iowa, United States

Site Status

ACCESS II Research Site

Medford, Oregon, United States

Site Status

ACCESS II Research Site

East Greenwich, Rhode Island, United States

Site Status

ACCESS II Research Site

North Charleston, South Carolina, United States

Site Status

ACCESS II Research Site

Dallas, Texas, United States

Site Status

ACCESS II Research Site

San Antonio, Texas, United States

Site Status

ACCESS II Research Site

West Jordan, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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GSBR-1290-09

Identifier Type: -

Identifier Source: org_study_id

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