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| ID | Type | Description | Link |
|---|---|---|---|
| I8F-MC-GPIQ | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to evaluate the efficacy and safety of tirzepatide for the maintenance of body weight reduction.
All enrolled participants will complete a 60-week open-label Weight-Loss Period on tirzepatide maximum tolerated dose (MTD) and upon meeting randomization criteria will enter a 52-week double-blinded Weight Maintenance Period to be assigned to either tirzepatide 5 mg, tirzepatide MTD or placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tirzepatide 5 milligram (mg) | Experimental | Participants will receive tirzepatide subcutaneously (SC). |
|
| Tirzepatide Maximum Tolerated Dose | Experimental | Participants will receive tirzepatide SC. |
|
| Placebo | Placebo Comparator | Participants will receive placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tirzepatide | Drug | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Maintenance of Body Weight (BW) Reduction Achieved during the 60-Week Weight Loss Period | Mean percent maintenance of BW reduction achieved during the 60-Week weight loss period will be measured in participants who have reached a BW plateau. | Week 112 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with an Assessment of (yes/no) of Maintaining ≥80% of the BW Reduction Achieved During the 60-week Weight-Loss Period | Assessment of (yes/no) of maintaining ≥80% of the BW reduction achieved during the 60-week weight loss period will be measured in participants who have reached a BW plateau. | Week 112 |
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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:
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.
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
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cahaba Research - Pelham | Pelham | Alabama | 35124 | United States | ||
| Velocity Clinical Research, Westlake |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42119587 | Derived | Horn DB, Aronne LJ, Wharton S, Bays HE, le Roux CW, Srinath R, Gomez-Valderas E, Arad AD, Das S, Dunn JP, Ribeiro A, Glass LC, Lee CJ. Tirzepatide for maintenance of bodyweight reduction in people with obesity in the USA (SURMOUNT-MAINTAIN): a multicentre, double-blind, randomised, placebo-controlled trial. Lancet. 2026 Jun 6;407(10545):2305-2318. doi: 10.1016/S0140-6736(26)00656-2. Epub 2026 May 12. | |
| 40916045 |
| Label | URL |
|---|---|
| A Study of LY3298176 (Tirzepatide) For the Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities | View source |
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Anonymized individual participant level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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3b
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| Placebo | Drug | Administered SC |
|
| Number of Participants with an Assessment of (yes/no) of Maintaining ≥ 15% BW Reduction for Participants Who Have Already Lost ≥15% BW at Randomization |
Assessment of (yes/no) of maintaining ≥15% BW reduction for participants who have already lost ≥15% BW at randomization will be measured in participants who have reached a BW plateau. |
| Week 112 |
| Percent Change from Baseline in Body Weight | Baseline (Week 0), Week 112 |
| Change from Randomization in Body Weight | Week 60, Week 112 |
| Percent Change from Randomization in Body Weight | Week 60, Week 112 |
| Change from Randomization in Waist Circumference | Week 60, Week 112 |
| Percent Maintenance of BW Reduction Achieved During the 60-week Weight-Loss Period | Week 84 |
| Los Angeles |
| California |
| 90057 |
| United States |
| Southern California Dermatology, Inc. | Santa Ana | California | 92701 | United States |
| Encompass Clinical Research | Spring Valley | California | 91978 | United States |
| New Horizon Research Center | Miami | Florida | 33165 | United States |
| Oviedo Medical Research | Oviedo | Florida | 32765 | United States |
| Rophe Adult and Pediatric Medicine/SKYCRNG | Union City | Georgia | 30291 | United States |
| East-West Medical Research Institute | Honolulu | Hawaii | 96814 | United States |
| Rocky Mountain Clinical Research | Idaho Falls | Idaho | 83404 | United States |
| Asha Clinical Research - Munster | Hammond | Indiana | 46324 | United States |
| Iowa Diabetes and Endocrinology Research Center | West Des Moines | Iowa | 50265 | United States |
| L-MARC Research Center | Louisville | Kentucky | 40213 | United States |
| Prime Health and Wellness/SKYCRNG | Fayette | Mississippi | 39069 | United States |
| Alliance for Multispecialty Research, LLC | Norman | Oklahoma | 73069 | United States |
| WR-Clinsearch, LLC | Chattanooga | Tennessee | 37397 | United States |
| The University of Texas Health Science Center at Houston | Bellaire | Texas | 77401 | United States |
| Velocity Clinical Research, Dallas | Dallas | Texas | 75230 | United States |
| Southern Endocrinology Associates | Mesquite | Texas | 75149 | United States |
| Pinnacle Clinical Research | San Antonio | Texas | 78229 | United States |
| Consano Clinical Research, LLC | Shavano Park | Texas | 78231 | United States |
| Derived |
| Horn DB, Aronne LJ, Wharton S, Bays HE, Gomez-Valderas E, Arad AD, Sharma P, Dunn JP, Senyucel C, Lee CJ. Tirzepatide for the Maintenance of Body Weight Reduction: Rationale, Design, and Baseline Characteristics of SURMOUNT-MAINTAIN. Obesity (Silver Spring). 2025 Oct;33(10):1873-1885. doi: 10.1002/oby.70014. Epub 2025 Sep 7. |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000098860 | Tirzepatide |
| ID | Term |
|---|---|
| D000067757 | Glucagon-Like Peptide-1 Receptor |
| D000067756 | Glucagon-Like Peptide Receptors |
| D043562 | Receptors, G-Protein-Coupled |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011964 | Receptors, Gastrointestinal Hormone |
| D018000 | Receptors, Peptide |
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