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

Phase 2

Active, not recruiting

• Conditions: Obesity; Overweight; Chronic Weight Management
• Interventions: Drug: aleniglipron or placebo

• Registration Number: NCT06703021
• Lead Sponsor: Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2024-11-15
• Study First Submitted QC: 2024-11-20
• Study First Posted: 2024-11-25
• Study Start: 2024-12-20
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-09
• Last Update Posted: 2025-09-15
• Primary Completion: 2025-11
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 82

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sentinel	aleniglipron or placebo	Participants will receive aleniglipron or placebo administered orally.
Cohort 1a	aleniglipron or placebo	Participants will receive aleniglipron or placebo administered orally.
Cohort 1b	aleniglipron or placebo	Participants will receive aleniglipron or placebo administered orally.
Cohort 1c	aleniglipron or placebo	Participants will receive aleniglipron or placebo administered orally.

Primary Outcome Measures

Name	Time	Method
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)	Baseline and week 44
Adverse events of special interest	Baseline and week 44
Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters, including hematology, plasma chemistry, coagulation, and urinalysis	Baseline and week 44
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameters: Common ECG-related variables will be assessed, including but not limited to : heart rate and QRS duration	Baseline and week 44
Number of Participants With Clinically Significant Change From Baseline in Vital Signs, including systolic and diastolic Blood Pressure, Heart Rate, Respiratory Rate, and temperature	Baseline and week 44

Secondary Outcome Measures

Name	Time	Method
Area Under the Plasma Concentration-time Curve From Time 0 to Tau (AUC0-tau)	Baseline and week 44
Maximum Observed Plasma Concentration (Cmax) of aleniglipron	Baseline and week 44
Trough Concentrations (Ctrough) of aleniglipron	Baseline and week 44
Time of Maximum Observed Plasma Concentration (Tmax) of aleniglipron	Baseline and week 44
Terminal Elimination Half-life (t1/2) for aleniglipron	Baseline and week 44

Trial Locations

Locations (1)

ACCESS II Research Site; 🇺🇸 West Jordan, Utah, United States