Aleniglipron Phase 2 Body Composition Study

NCT ID: NCT07169942

Last Updated: 2025-10-31

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

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-15

Study Completion Date

2026-09-30

Brief Summary

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This is a randomized, double-blind, placebo-controlled study evaluating the effects of aleniglipron on body composition in participants living with obesity. Participants will be randomized to aleniglipron or placebo in a ratio of 5:1. Participants will receive multiple ascending QD doses of aleniglipron or placebo in titration steps of 4 weeks duration for a total of 40 weeks of treatment.

Detailed Description

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Conditions

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Obesity, Overweight, or Chronic Weight Management

Keywords

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obesity, overweight, GSBR-1290, aleniglipron, chronic weight management, obese, small molecule, GLP-1 receptor agonist, body composition, 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

Interventions

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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
* Participants age ≥18 years and \<80 years, with BMI ≥30 kg/m2
* Screening HbA1c \<6.5 %

Exclusion Criteria

* Previous documented diagnosis of diabetes mellitus
* Self-reported change in body weight \>5% within 3 months before Screening
* Have a body weight, height, and/or width that prohibits the ability to obtain accurate measurements according to the DXA study specific manual that allows hemi-scan
* Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty, if performed \>1 year prior to screening)
* Have obesity induced by other endocrine disorders (such as Cushing's syndrome, Prader-Willi syndrome, or melanocortin 4 receptor deficiency)
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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Research Site

Phoenix, Arizona, United States

Site Status

Research Site

Chicago, Illinois, United States

Site Status

Research Site

Richfield, Minnesota, United States

Site Status

Research Site

City of Saint Peters, Missouri, United States

Site Status

Research Site

Rochester, New York, United States

Site Status

Research Site

Wilmington, North Carolina, United States

Site Status

Research Site

Norman, Oklahoma, United States

Site Status

Research Site

Moncks Corner, South Carolina, United States

Site Status

Research Site

North Charleston, South Carolina, United States

Site Status

Research Site

Austin, Texas, United States

Site Status

Research Site

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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GSBR-1290-16

Identifier Type: -

Identifier Source: org_study_id