Clincosm LogoSign in Get a demo

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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06047548
Collaborator
(none)
400
Enrollment
20
Locations
3
Arms
31.7
Anticipated Duration (Months)
20
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
3b3b
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
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)
Anticipated Study Start Date :
Sep 29, 2023
Anticipated Primary Completion Date :
May 22, 2026
Anticipated Study Completion Date :
May 22, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tirzepatide 5 milligram (mg)

Participants will receive tirzepatide subcutaneously (SC).

Drug: Tirzepatide
Administered SC
Other Names:
  • LY3298176

    		•
    Experimental: Tirzepatide Maximum Tolerated Dose

    Participants will receive tirzepatide SC.

    Drug: Tirzepatide
    Administered SC
    Other Names:
  • LY3298176

    		•
    Placebo Comparator: Placebo

    Participants will receive placebo.

    Drug: Placebo
    Administered SC

    Outcome Measures

    Primary Outcome Measures

    1. Percent Maintenance of Body Weight (BW) Reduction Achieved during the 60-Week Weight Loss Period [Week 112]

      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.

    Secondary Outcome Measures

    1. Number of Participants with an Assessment of (yes/no) of Maintaining ≥80% of the BW Reduction Achieved During the 60-week Weight-Loss Period [Week 112]

      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.

    2. Number of Participants with an Assessment of (yes/no) of Maintaining ≥ 15% BW Reduction for Participants Who Have Already Lost ≥15% BW at Randomization [Week 112]

      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.

    3. Percent Change from Baseline in Body Weight [Baseline (Week 0), Week 112]

    4. Change from Randomization in Body Weight [Week 60, Week 112]

    5. Percent Change from Randomization in Body Weight [Week 60, Week 112]

    6. Change from Randomization in Waist Circumference [Week 60, Week 112]

    7. Percent Maintenance of BW Reduction Achieved During the 60-week Weight-Loss Period [Week 84]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cahaba Research - Pelham Pelham Alabama United States 35124
    2 National Research Institute - Wilshire Los Angeles California United States 90057
    3 Southern California Dermatology, Inc. Santa Ana California United States 92701
    4 Encompass Clinical Research Spring Valley California United States 91978
    5 New Horizon Research Center Miami Florida United States 33165
    6 Oviedo Medical Research Oviedo Florida United States 32765
    7 Rophe Adult and Pediatric Medicine/SKYCRNG Union City Georgia United States 30291
    8 East-West Medical Research Institute Honolulu Hawaii United States 96814
    9 Rocky Mountain Clinical Research Idaho Falls Idaho United States 83404
    10 Asha Clinical Research - Munster Hammond Indiana United States 46324
    11 Iowa Diabetes and Endocrinology Research Center West Des Moines Iowa United States 50265
    12 L-MARC Research Center Louisville Kentucky United States 40213
    13 Prime Health and Wellness/SKYCRNG Fayette Mississippi United States 39069
    14 Alliance for Multispecialty Research, LLC Norman Oklahoma United States 73069
    15 WR-Clinsearch, LLC Chattanooga Tennessee United States 37421
    16 Velocity Clinical Research, Dallas Dallas Texas United States 75230
    17 The University of Texas Health Science Center at Houston Houston Texas United States 77030
    18 Southern Endocrinology Associates Mesquite Texas United States 75149
    19 Pinnacle Clinical Research San Antonio Texas United States 78229
    20 Consano Clinical Research, LLC Shavano Park Texas United States 78231

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • Study Director: 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT06047548
    Other Study ID Numbers:
    • 18720
    • I8F-MC-GPIQ
    First Posted:
    Sep 21, 2023
    Last Update Posted:
    Sep 21, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Obesity
    Overweight
    Body Weight
    Weight Loss
    Tirzepatide

    Study Results

    No Results Posted as of Sep 21, 2023