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

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)

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight; Chronic Weight Management
• Intervention / Treatment: Drug: aleniglipron or placebo

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Glendale, California, United States, 91206
      • ACCESS II Research Site
    • Montclair, California, United States, 91763
      • ACCESS II Research Site
  • Indiana
    • Valparaiso, Indiana, United States, 46383
      • ACCESS II Research Site
  • Iowa
    • West Des Moines, Iowa, United States, 50265
      • ACCESS II Research Site
  • Oregon
    • Medford, Oregon, United States, 97504
      • ACCESS II Research Site
  • Rhode Island
    • East Greenwich, Rhode Island, United States, 02818
      • ACCESS II Research Site
  • South Carolina
    • North Charleston, South Carolina, United States, 29405
      • ACCESS II Research Site
  • Texas
    • Dallas, Texas, United States, 75042
      • ACCESS II Research Site
    • San Antonio, Texas, United States, 78240
      • ACCESS II Research Site
  • Utah
    • West Jordan, Utah, United States, 84088
      • ACCESS II Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sentinel; Participants will receive aleniglipron or placebo administered orally.	Drug: aleniglipron or placebo; Drug: aleniglipron administered orally; Drug: placebo administered orally
Experimental: Cohort 1a; Participants will receive aleniglipron or placebo administered orally.	Drug: aleniglipron or placebo; Drug: aleniglipron administered orally; Drug: placebo administered orally
Experimental: Cohort 1b; Participants will receive aleniglipron or placebo administered orally.	Drug: aleniglipron or placebo; Drug: aleniglipron administered orally; Drug: placebo administered orally
Experimental: Cohort 1c; Participants will receive aleniglipron or placebo administered orally.	Drug: aleniglipron or placebo; Drug: aleniglipron administered orally; Drug: placebo administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Other Outcome Measures

Outcome Measure	Time Frame
Percent change in body weight	Baseline and week 44
Change in body weight (absolute)	Baseline and week 44
Percentage of participants who achieve ≥5% reduction in body weight at Week 44	Baseline and week 44
Percentage of participants who achieve ≥10% reduction in body weight at Week 44	Baseline and week 44
Percentage of participants who achieve ≥15% reduction in body weight at Week 44	Baseline and week 44
Change in waist circumference	Baseline and week 44
Change in body mass index	Baseline and week 44
Change in patient-reported outcomes (hunger and satiety questionnaire)	Baseline and week 44
Change in HDL and LDL cholesterol	Baseline and week 44

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2024
• Primary Completion (Actual): January 12, 2026
• Study Completion (Actual): January 12, 2026

Study Registration Dates

• First Submitted: November 15, 2024
• First Submitted That Met QC Criteria: November 20, 2024
• First Posted (Actual): November 25, 2024

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Obesity; Overweight; Obese; Chronic weight management; ACCESS II; GSBR-1290; Small molecule GLP-1 receptor agonist; Structure Therapeutics
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: GSBR-1290-09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual patient data for variables necessary to address a specific research question in an approved data sharing request
• IPD Sharing Time Frame: Data sharing requests will be considered beginning 36 months after the study publication (manuscript accepted for publication) and either 1) the product has been granted marketing authorization in at least two regulatory jurisdictions, or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.

IPD Sharing Access Criteria

Researchers will submit a request containing the research objectives, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). Structure Therapeutics does not grant external requests for individual de-identified patient data for the following purposes:

• Re-evaluating safety and efficacy end points already addressed in the product labelling,
• Assessing safety or efficacy for an indication in current development Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a panel of external advisors. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No