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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 ≥30•HbA1c ≤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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
Exclusion criteria
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 endpointsPercent change in total body fat mass by DXA
Time frame:Baseline and week 44
Total fat mass
percent change from baseline, improvement
Percent change in visceral adipose tissue [VAT] by DXA
Time frame:Baseline and week 44
Visceral fat, change
percent change from baseline, improvement
Percent change in lean body mass by DXA
Time frame:Baseline and week 44
Lean mass
percent change from baseline, improvement
Percent change in body weight by DXA
Time frame:Baseline and week 44
Body weight, % change
percent change from baseline, improvement
Percent change in waist circumference
Time frame:Baseline and week 44
Waist circumference, change
percent change from baseline, improvement
Cardiometabolic biomarkers
1 endpointChange 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 endpointsChange in patient-reported outcome SF-36 acute version
Time frame:Baseline and week 44
SF-36 total
change from baseline, improvement
Change in patient-reported outcome IWQOL-Lite CT
Time frame:Baseline and week 44
IWQOL-Lite total
change from baseline, improvement
Change in patient-reported outcome hunger/satiety evaluation checklist
Time frame:Baseline and week 44
change from baseline, improvement
Provenance
Sources
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.