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A Study of LY3298176 (Tirzepatide) For the Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities
A Phase 3b, Randomized Controlled Study to Evaluate the Efficacy and Safety of Tirzepatide Once Weekly 5 mg and/or Maximum Tolerated Dose Versus Placebo for Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities (SURMOUNT-MAINTAIN)
Lead sponsor
Asset
Tirzepatide
Subcutaneous · GLP-1 / GIP dual
Listed sites
20
Recruiting sites
—
Enrollment
441
actual
Study population
Obesity / overweight
Key I/E criterion
•BMI ≥30
Primary endpoint
•Body weight, % change
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 (8)
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.
Weight & body composition
8 endpointsPercent Maintenance of Body Weight (BW) Reduction Achieved during the 60-Week Weight Loss Period
Time frame:Week 112
Body weight, % change
percent change from baseline, improvement
Number of Participants with an Assessment of (yes/no) of Maintaining ≥80% of the BW Reduction Achieved During the 60-week Weight-Loss Period
Time frame:Week 112
threshold achievement, improvement
Number of Participants with an Assessment of (yes/no) of Maintaining ≥ 15% BW Reduction for Participants Who Have Already Lost ≥15% BW at Randomization
Time frame:Week 112
≥15% weight-loss responders
threshold achievement, improvement
Percent Change from Baseline in Body Weight
Time frame:Baseline (Week 0), Week 112
Body weight, % change
percent change from baseline, improvement
Change from Randomization in Body Weight
Time frame:Week 60, Week 112
Body weight, absolute change (kg)
change from baseline, improvement
Percent Change from Randomization in Body Weight
Time frame:Week 60, Week 112
Body weight, % change
percent change from baseline, improvement
Change from Randomization in Waist Circumference
Time frame:Week 60, Week 112
Waist circumference, change
change from baseline, improvement
Percent Maintenance of BW Reduction Achieved During the 60-week Weight-Loss Period
Time frame:Week 84
Body weight, % change
percent change from baseline, improvement
Publications (1)
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
- Obesity (Silver Spring, Md.)2025 Oct (month)PMID40916045doi:10.1002/oby.70014via clinicaltrials gov reference derived + pubmed nct search
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.