A Study of LY3298176 (Tirzepatide) For the Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities
NCT ID: NCT06047548
Last Updated: 2025-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
400 participants
INTERVENTIONAL
2023-09-20
2026-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Tirzepatide 5 milligram (mg)
Participants will receive tirzepatide subcutaneously (SC).
Tirzepatide
Administered SC
Tirzepatide Maximum Tolerated Dose
Participants will receive tirzepatide SC.
Tirzepatide
Administered SC
Placebo
Participants will receive placebo.
Placebo
Administered SC
Interventions
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Tirzepatide
Administered SC
Placebo
Administered SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Cahaba Research - Pelham
Pelham, Alabama, United States
Velocity Clinical Research, Westlake
Los Angeles, California, United States
Southern California Dermatology, Inc.
Santa Ana, California, United States
Encompass Clinical Research
Spring Valley, California, United States
New Horizon Research Center
Miami, Florida, United States
Oviedo Medical Research
Oviedo, Florida, United States
Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, Georgia, United States
East-West Medical Research Institute
Honolulu, Hawaii, United States
Rocky Mountain Clinical Research
Idaho Falls, Idaho, United States
Asha Clinical Research - Munster
Hammond, Indiana, United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, United States
L-MARC Research Center
Louisville, Kentucky, United States
Prime Health and Wellness/SKYCRNG
Fayette, Mississippi, United States
Alliance for Multispecialty Research, LLC
Norman, Oklahoma, United States
WR-Clinsearch, LLC
Chattanooga, Tennessee, United States
The University of Texas Health Science Center at Houston
Bellaire, Texas, United States
Velocity Clinical Research, Dallas
Dallas, Texas, United States
Southern Endocrinology Associates
Mesquite, Texas, United States
Pinnacle Clinical Research
San Antonio, Texas, United States
Consano Clinical Research, LLC
Shavano Park, Texas, United States
Countries
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References
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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.
Related Links
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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
Other Identifiers
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I8F-MC-GPIQ
Identifier Type: OTHER
Identifier Source: secondary_id
18720
Identifier Type: -
Identifier Source: org_study_id
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