A Study of LY3298176 (Tirzepatide) For the Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities

Last updated: April 17, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Not Recruiting

Phase

3

Condition

Weight Loss

Obesity

Diabetes Prevention

Treatment

Placebo

Tirzepatide

Clinical Study ID

NCT06047548
18720
I8F-MC-GPIQ
  • Ages > 18
  • All Genders

Study Summary

The main purpose of this study is to evaluate the efficacy and safety of tirzepatide for the maintenance of body weight reduction.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have a Body Mass Index (BMI) of ≥30 kilogram/square meter (kg/m²) or ≥27 kg/m² andpreviously 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 bodyweight (BW)

Exclusion

Exclusion Criteria:

  • Have Type 1 Diabetes (T1D) or Type 2 Diabetes (T2D), a history of ketoacidosis, orhyperosmolar 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 orabdominoplasty 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), unstableangina, and hospitalization due to congestive heart failure (CHF)

  • family or personal history of medullary thyroid carcinoma (MTC) or multipleendocrine neoplasia syndrome type 2 (MEN-2)

  • History of significant active or unstable major depressive disorder (MDD) or othersevere psychiatric disorder within the last 2 years

  • Any lifetime history of a suicide attempt

Study Design

Total Participants: 400
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
September 20, 2023
Estimated Completion Date:
May 31, 2026

Study Description

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.

Connect with a study center

  • Cahaba Research - Pelham

    Pelham, Alabama 35124
    United States

    Site Not Available

  • National Research Institute - Wilshire

    Los Angeles, California 90057
    United States

    Site Not Available

  • Velocity Clinical Research, Westlake

    Los Angeles, California 90057
    United States

    Site Not Available

  • Southern California Dermatology, Inc.

    Santa Ana, California 92701
    United States

    Site Not Available

  • Encompass Clinical Research

    Spring Valley, California 91978
    United States

    Site Not Available

  • New Horizon Research Center

    Miami, Florida 33165
    United States

    Site Not Available

  • Oviedo Medical Research

    Oviedo, Florida 32765
    United States

    Site Not Available

  • Rophe Adult and Pediatric Medicine/SKYCRNG

    Union City, Georgia 30291
    United States

    Site Not Available

  • East-West Medical Research Institute

    Honolulu, Hawaii 96814
    United States

    Site Not Available

  • Rocky Mountain Clinical Research

    Idaho Falls, Idaho 83404
    United States

    Site Not Available

  • Asha Clinical Research - Munster

    Hammond, Indiana 46324
    United States

    Site Not Available

  • Iowa Diabetes and Endocrinology Research Center

    West Des Moines, Iowa 50265
    United States

    Site Not Available

  • L-MARC Research Center

    Louisville, Kentucky 40213
    United States

    Site Not Available

  • Prime Health and Wellness/SKYCRNG

    Fayette, Mississippi 39069
    United States

    Site Not Available

  • SKY Clinical Research Network Group - Hall

    Fayette, Mississippi 39069
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC

    Norman, Oklahoma 73069
    United States

    Site Not Available

  • Intend Research, LLC

    Norman, Oklahoma 73069
    United States

    Site Not Available

  • WR-Clinsearch, LLC

    Chattanooga, Tennessee 37397
    United States

    Site Not Available

  • The University of Texas Health Science Center at Houston

    Bellaire, Texas 77401
    United States

    Site Not Available

  • Dallas Diabetes Research Center

    Dallas, Texas 75230
    United States

    Site Not Available

  • Velocity Clinical Research, Dallas

    Dallas, Texas 75230
    United States

    Site Not Available

  • The University of Texas Health Science Center at Houston

    Houston, Texas 77030
    United States

    Site Not Available

  • Southern Endocrinology Associates

    Mesquite, Texas 75149
    United States

    Site Not Available

  • Pinnacle Clinical Research

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Consano Clinical Research, LLC

    Shavano Park, Texas 78231
    United States

    Site Not Available

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