ACCESS II

CompletedPhase 2

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

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)

Lead sponsor

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

Asset

Aleniglipron / GSBR-1290

Oral · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥30

Primary endpoints

•Treatment-emergent AEs (any)•Adverse events of special interest•Laboratory Parameters

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06703021

Org study IDGSBR-1290-09

Timeline

Milestones

Study first posted2024-11-25actual

Study start2024-12-20actual

Primary completion2026-01-12actual

Study completion2026-01-12actual

Last update posted2026-04-28actual

Assets

Investigational agents

Aleniglipron / GSBR-1290

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age79 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (19)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Weight & body composition

Cardiometabolic biomarkers

Patient-reported / QoL

Weight & body composition

7 endpoints

Other/protocol endpoint

Percent change in body weight

Time frame:Baseline and week 44

Body weight, % change

percent change from baseline, improvement

Other/protocol endpoint

Change in body weight (absolute)

Time frame:Baseline and week 44

Body weight, absolute change (kg)

change from baseline, improvement

Other/protocol endpoint

Percentage of participants who achieve ≥5% reduction in body weight at Week 44

Time frame:Baseline and week 44

≥5% weight-loss responders

threshold achievement, improvement

Other/protocol endpoint

Percentage of participants who achieve ≥10% reduction in body weight at Week 44

Time frame:Baseline and week 44

≥10% weight-loss responders

threshold achievement, improvement

Other/protocol endpoint

Percentage of participants who achieve ≥15% reduction in body weight at Week 44

Time frame:Baseline and week 44

≥15% weight-loss responders

threshold achievement, improvement

Other/protocol endpoint

Change in waist circumference

Time frame:Baseline and week 44

Waist circumference, change

change from baseline, improvement

Other/protocol endpoint

Change in body mass index

Time frame:Baseline and week 44

BMI, change

change from baseline, improvement

Cardiometabolic biomarkers

1 endpoint

Other/protocol endpoint

Change in HDL and LDL cholesterol

Time frame:Baseline and week 44

change from baseline, improvement

Patient-reported / QoL

1 endpoint

Other/protocol endpoint

Change in patient-reported outcomes (hunger and satiety questionnaire)

Time frame:Baseline and week 44

change from baseline, improvement

Safety / tolerability / PK

10 endpoints

Primary/protocol endpoint

Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)

Time frame:Baseline and week 44

Treatment-emergent AEs (any)

descriptive

Primary/protocol endpoint

Adverse events of special interest

Time frame:Baseline and week 44

descriptive, event

Primary/protocol endpoint

Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters, including hematology, plasma chemistry, coagulation, and urinalysis

Time frame:Baseline and week 44

descriptive

Primary/protocol endpoint

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

Time frame:Baseline and week 44

threshold achievement, event

Primary/protocol endpoint

Number of Participants With Clinically Significant Change From Baseline in Vital Signs, including systolic and diastolic Blood Pressure, Heart Rate, Respiratory Rate, and temperature

Time frame:Baseline and week 44

change from baseline, descriptive

Secondary/protocol endpoint

Area Under the Plasma Concentration-time Curve From Time 0 to Tau (AUC0-tau)

Time frame:Baseline and week 44

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Maximum Observed Plasma Concentration (Cmax) of aleniglipron

Time frame:Baseline and week 44

Cmax

concentration, descriptive

Secondary/protocol endpoint

Trough Concentrations (Ctrough) of aleniglipron

Time frame:Baseline and week 44

Plasma concentration (steady state)

concentration, descriptive

Secondary/protocol endpoint

Time of Maximum Observed Plasma Concentration (Tmax) of aleniglipron

Time frame:Baseline and week 44

Tmax

descriptive

Secondary/protocol endpoint

Terminal Elimination Half-life (t1/2) for aleniglipron

Time frame:Baseline and week 44

Half-life

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.