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Active not recruitingPhase 2

A Phase 2b, Dose-range Finding Study of the Efficacy and Safety of Multiple Doses of Aleniglipron (GSBR-1290) in Participants Living With Obesity or Overweight With at Least One Weight-related Comorbidity

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

Asset

Aleniglipron / GSBR-1290

Oral · GLP-1 agonist

Listed sites

39

Recruiting sites

—

Enrollment

220

estimated

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥30

Primary endpoints

•Body weight, % change•Treatment-emergent AEs (any) (Treatment-emergent AEs (any), Serious AEs (any))•AESI

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 IDNCT06693843
Org study IDGSBR-1290-06

Timeline

Milestones

Study start2024-10-28actual
Study first posted2024-11-18actual
Primary completion2025-10-24actual
Last update posted2026-04-28actual
Study completion2026-08estimated (month precision)

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
•Body weight ≤80 kg at Screening
•Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty, if performed >1 year 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

Weight & body composition
14
Safety / tolerability / PK
5

Weight & body composition

14 endpoints
Primary/protocol endpoint

Percent change in body weight from Baseline to Week 36

Time frame:Baseline and week 36

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Percentage of participants who achieve ≥5% reduction in body weight at Week 36

Time frame:Baseline and week 36

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of participants who achieve ≥10% reduction in body weight at Week 36

Time frame:Baseline and week 36

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of participants who achieve ≥15% reduction in body weight at Week 36

Time frame:Baseline and week 36

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change in body weight (absolute) from Baseline to Week 36

Time frame:Baseline and week 36

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in waist circumference from Baseline to Week 36

Time frame:Baseline and week 36

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change in body mass index from Baseline to Week 36

Time frame:Baseline and week 36

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Percent change in body weight

Time frame:Baseline to week 72 & Week 36-72

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline to week 72 & Week 36-72

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

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

Time frame:Baseline to week 72 & Week 36-72

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

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

Time frame:Baseline to week 72 & Week 36-72

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change in body weight

Time frame:Baseline to week 72 & Week 36-72

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in body mass

Time frame:Baseline to week 72 & Week 36-72

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in waist circumference

Time frame:Baseline to week 72 & Week 36-72

Waist circumference, change

change from baseline, improvement

Safety / tolerability / PK

5 endpoints
Primary/protocol endpoint

TEAEs and SAEs

Time frame:Baseline and week 72

Treatment-emergent AEs (any)

descriptive

componentsTreatment-emergent AEs (any), Serious AEs (any)

Primary/protocol endpoint

AESI

Time frame:Baseline and week 72

descriptive

Primary/protocol endpoint

Evaluate the safety and tolerability of participants with abnormal laboratory values, including hematology, serum chemistry, and coagulation

Time frame:Baseline and week 72

descriptive

Primary/protocol endpoint

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)

Time frame:Baseline and week 72

descriptive

Primary/protocol endpoint

Evaluate the safety and tolerability of participants with abnormal vital signs, including blood pressure, heart rate, and temperature

Time frame:Baseline and week 72

descriptive

componentsSystolic BP, change, Diastolic BP, change, Heart rate, change

Publications (10)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.