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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

NCT06693843 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2026-04-28

No results posted yet for this study

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

Interventions

DRUG

Aleniglipron or Placebo

Drug: Aleniglipron Administered orally Drug: Placebo Administered orally

DRUG

Aleniglipron or Placebo

Drug: Aleniglipron Administered orally Drug: Placebo Administered orally

DRUG

Aleniglipron or Placebo

Drug: Aleniglipron Administered orally Drug: Placebo Administered orally

DRUG

Aleniglipron

Drug: Aleniglipron Administered orally

DRUG

Aleniglipron

Drug: Aleniglipron Administered orally

DRUG

Aleniglipron

Drug: Aleniglipron Administered orally

DRUG

Aleniglipron

Drug: Aleniglipron Administered orally

Sponsors & Collaborators

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

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-28
Primary Completion
2025-10-24
Completion
2026-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06693843 on ClinicalTrials.gov