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CompletedPhase 3

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)

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

NCT IDNCT06047548
Org study ID18720
Secondary IDI8F-MC-GPIQEli Lilly and Company

Timeline

Milestones

Study start2023-09-20actual
Study first posted2023-09-21actual
Primary completion2026-01-20actual
Study completion2026-01-20actual
Last update posted2026-03-25actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

Have a Body Mass Index (BMI) of ≥30 kilogram/square meter (kg/m²) or ≥27 kg/m² and previously diagnosed with at least 1 of the following weight related comorbidities:
Hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease
Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight (BW)

Exclusion criteria

Have Type 1 Diabetes (T1D) or Type 2 Diabetes (T2D), a history of ketoacidosis, or hyperosmolar state or coma.
Have a self-reported change in BW>5 kilogram (kg) within 3 months prior to screening
Have a prior or planned surgical treatment for obesity, excluding liposuction or abdominoplasty if performed >1 year prior to screening.
Have a history of chronic or acute pancreatitis
Have any of the following cardiovascular conditions within 3 months prior to week 0.
Acute myocardial infarction, cerebrovascular accident (stroke), unstable angina, and hospitalization due to congestive heart failure (CHF)
family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder within the last 2 years
Any lifetime history of a suicide attempt

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 endpoints
Primary/protocol endpoint

Percent 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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

Percent Change from Baseline in Body Weight

Time frame:Baseline (Week 0), Week 112

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change from Randomization in Body Weight

Time frame:Week 60, Week 112

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Percent Change from Randomization in Body Weight

Time frame:Week 60, Week 112

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change from Randomization in Waist Circumference

Time frame:Week 60, Week 112

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

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

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.