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

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-20

Study Completion Date

2026-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Overweight Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

3b
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Tirzepatide 5 milligram (mg)

Participants will receive tirzepatide subcutaneously (SC).

Group Type EXPERIMENTAL

Tirzepatide

Intervention Type DRUG

Administered SC

Tirzepatide Maximum Tolerated Dose

Participants will receive tirzepatide SC.

Group Type EXPERIMENTAL

Tirzepatide

Intervention Type DRUG

Administered SC

Placebo

Participants will receive placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered SC

Interventions

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Tirzepatide

Administered SC

Intervention Type DRUG

Placebo

Administered SC

Intervention Type DRUG

Other Intervention Names

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LY3298176

Eligibility Criteria

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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:

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Velocity Clinical Research, Westlake

Los Angeles, California, United States

Site Status

Southern California Dermatology, Inc.

Santa Ana, California, United States

Site Status

Encompass Clinical Research

Spring Valley, California, United States

Site Status

New Horizon Research Center

Miami, Florida, United States

Site Status

Oviedo Medical Research

Oviedo, Florida, United States

Site Status

Rophe Adult and Pediatric Medicine/SKYCRNG

Union City, Georgia, United States

Site Status

East-West Medical Research Institute

Honolulu, Hawaii, United States

Site Status

Rocky Mountain Clinical Research

Idaho Falls, Idaho, United States

Site Status

Asha Clinical Research - Munster

Hammond, Indiana, United States

Site Status

Iowa Diabetes and Endocrinology Research Center

West Des Moines, Iowa, United States

Site Status

L-MARC Research Center

Louisville, Kentucky, United States

Site Status

Prime Health and Wellness/SKYCRNG

Fayette, Mississippi, United States

Site Status

Alliance for Multispecialty Research, LLC

Norman, Oklahoma, United States

Site Status

WR-Clinsearch, LLC

Chattanooga, Tennessee, United States

Site Status

The University of Texas Health Science Center at Houston

Bellaire, Texas, United States

Site Status

Velocity Clinical Research, Dallas

Dallas, Texas, United States

Site Status

Southern Endocrinology Associates

Mesquite, Texas, United States

Site Status

Pinnacle Clinical Research

San Antonio, Texas, United States

Site Status

Consano Clinical Research, LLC

Shavano Park, Texas, United States

Site Status

Countries

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United States

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.

Reference Type DERIVED
PMID: 40916045 (View on PubMed)

Related Links

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https://trials.lilly.com/en-US/trial/424336

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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