A Phase 2b, Randomized, Double-blind, Placebo-controlled, Dose-range Finding Study of the Efficacy and Safety of Multiple Doses of Aleniglipron (GSBR-1290) in Participants Living With Obesity (Body Mass Index ≥ 30 kg/m2) or Overweight (Body Mass Index ≥ 27 kg/m2) With at Least One Weight-related Comorbidity

Registration

Registration

NCT06693843

Acronym

ACCESS

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE2

Masking

TRIPLE

Status

COMPLETED

Enrollment

230

Start

2024-10-28

Primary completion

2025-10-24

Lead sponsor

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

Conditions

Obesity, Overweight, or Chronic Weight Management

Interventions

DRUG:Aleniglipron or Placebo; DRUG:Aleniglipron

Results posted

FALSE

Individual participant data sharing

YES

Registered primary outcomes

• Percent change in body weight from Baseline to Week 36 [Baseline and week 36]
• TEAEs and SAEs [Baseline and week 72]
• AESI [Baseline and week 72]
• Evaluate the safety and tolerability of participants with abnormal laboratory values, including hematology, serum chemistry, and coagulation [Baseline and week 72]
• Evaluate long-term safety and tolerability of aleniglipron as measured through electrocardiograms (including, but not limited to, the measurements of ventricular HR, PR interval, QRS duration, QT interval, and QTcF) [Baseline and week 72]
• Evaluate the safety and tolerability of participants with abnormal vital signs, including blood pressure, heart rate, and temperature [Baseline and week 72]