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Active not recruitingPhase 2

Aleniglipron Phase 2 Body Composition Study

A Phase 2, Randomized, Double-blind, Placebo-controlled, Study Evaluating the Effects of Aleniglipron (GSBR-1290) on Body Composition in Participants Living With Obesity (Body Mass Index ≥ 30 kg/m2)

Asset

Aleniglipron / GSBR-1290

Oral · GLP-1 agonist

Listed sites

11

Recruiting sites

Enrollment

71

actual

Study population

Obesity / overweight

Key I/E criteria

BMI ≥30HbA1c ≤6.5%

Primary endpoint

Total fat mass

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 IDNCT07169942
Org study IDGSBR-1290-16

Timeline

Milestones

Study start2025-08-15actual
Study first posted2025-09-12actual
Last update posted2026-03-03actual
Primary completion2026-08estimated (month precision)
Study completion2026-10estimated (month precision)

Assets

Investigational agents

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
Participants age ≥18 years and <80 years, with BMI ≥30 kg/m2
Screening HbA1c <6.5 %

Exclusion criteria

Previous documented diagnosis of diabetes mellitus
Self-reported change in body weight >5% within 3 months before Screening
Have a body weight, height, and/or width that prohibits the ability to obtain accurate measurements according to the DXA study specific manual that allows hemi-scan
Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty, if performed >1 year prior to screening)
Have obesity induced by other endocrine disorders (such as Cushing's syndrome, Prader-Willi syndrome, or melanocortin 4 receptor deficiency)

Endpoints (9)

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
5
Patient-reported / QoL
3
Cardiometabolic biomarkers
1

Weight & body composition

5 endpoints
Primary/protocol endpoint

Percent change in total body fat mass by DXA

Time frame:Baseline and week 44

Total fat mass

percent change from baseline, improvement

Secondary/protocol endpoint

Percent change in visceral adipose tissue [VAT] by DXA

Time frame:Baseline and week 44

Visceral fat, change

percent change from baseline, improvement

Secondary/protocol endpoint

Percent change in lean body mass by DXA

Time frame:Baseline and week 44

Lean mass

percent change from baseline, improvement

Secondary/protocol endpoint

Percent change in body weight by DXA

Time frame:Baseline and week 44

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Percent change in waist circumference

Time frame:Baseline and week 44

Waist circumference, change

percent change from baseline, improvement

Cardiometabolic biomarkers

1 endpoint
Other/protocol endpoint

Change in high-density lipoprotein and low-density lipoprotein cholesterol

Time frame:Baseline and week 44

change from baseline, improvement

componentsHDL-C, change, LDL-C, change

Patient-reported / QoL

3 endpoints
Other/protocol endpoint

Change in patient-reported outcome SF-36 acute version

Time frame:Baseline and week 44

SF-36 total

change from baseline, improvement

Other/protocol endpoint

Change in patient-reported outcome IWQOL-Lite CT

Time frame:Baseline and week 44

IWQOL-Lite total

change from baseline, improvement

Other/protocol endpoint

Change in patient-reported outcome hunger/satiety evaluation checklist

Time frame:Baseline and week 44

change from baseline, improvement

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.