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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06703021

Acronym

ACCESS II

Enrollment

Registered

2024-11-25

Start date

2024-12-20

Completion date

2026-01-12

Last updated

2026-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Weight Management, Obesity, Overweight

Keywords

ACCESS II, Obesity, Overweight, GSBR-1290, Chronic weight management, Obese, Small molecule GLP-1 receptor agonist, 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.

Interventions

DRUGaleniglipron or placebo

Drug: aleniglipron administered orally; Drug: placebo administered orally

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 79 Years

Healthy volunteers

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

Design outcomes

Primary

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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 29, 2026