A Phase 2, Randomized, Double-blind, Placebo-controlled, Study of the Safety, Tolerability, and Efficacy of Increasing Optimal 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 (ACCESS II)

Registration

Registration

NCT06703021

Acronym

ACCESS II

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE2

Masking

TRIPLE

Status

COMPLETED

Enrollment

85

Start

2024-12-20

Primary completion

2026-01-12

Lead sponsor

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

Conditions

Obesity; Overweight; Chronic Weight Management

Interventions

DRUG:aleniglipron or placebo

Results posted

FALSE

Individual participant data sharing

YES

Registered primary outcomes

• 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]