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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

Primary Purpose

Overweight, Obesity

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tirzepatide
Placebo
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cahaba Research - Pelham
  • National Research Institute - WilshireRecruiting
  • Southern California Dermatology, Inc.
  • Encompass Clinical Research
  • New Horizon Research Center
  • Oviedo Medical Research
  • Rophe Adult and Pediatric Medicine/SKYCRNGRecruiting
  • East-West Medical Research InstituteRecruiting
  • Rocky Mountain Clinical Research
  • Asha Clinical Research - Munster
  • Iowa Diabetes and Endocrinology Research CenterRecruiting
  • L-MARC Research CenterRecruiting
  • Prime Health and Wellness/SKYCRNG
  • Alliance for Multispecialty Research, LLCRecruiting
  • The University of Texas Health Science Center at HoustonRecruiting
  • Dallas Diabetes Research CenterRecruiting
  • Southern Endocrinology AssociatesRecruiting
  • Pinnacle Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Tirzepatide 5 milligram (mg)

Tirzepatide Maximum Tolerated Dose

Placebo

Arm Description

Participants will receive tirzepatide subcutaneously (SC).

Participants will receive tirzepatide SC.

Participants will receive placebo.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Percent Change from Baseline in Body Weight
Change from Randomization in Body Weight
Percent Change from Randomization in Body Weight
Change from Randomization in Waist Circumference
Percent Maintenance of BW Reduction Achieved During the 60-week Weight-Loss Period

Full Information

First Posted
September 14, 2023
Last Updated
October 19, 2023
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT06047548
Brief Title
A Study of LY3298176 (Tirzepatide) For the Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 1, 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 20, 2023 (Actual)
Primary Completion Date
May 22, 2026 (Anticipated)
Study Completion Date
May 22, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
3b
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tirzepatide 5 milligram (mg)
Arm Type
Experimental
Arm Description
Participants will receive tirzepatide subcutaneously (SC).
Arm Title
Tirzepatide Maximum Tolerated Dose
Arm Type
Experimental
Arm Description
Participants will receive tirzepatide SC.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo.
Intervention Type
Drug
Intervention Name(s)
Tirzepatide
Other Intervention Name(s)
LY3298176
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Percent Maintenance of Body Weight (BW) Reduction Achieved during the 60-Week Weight Loss Period
Description
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.
Time Frame
Week 112
Secondary Outcome Measure Information:
Title
Number of Participants with an Assessment of (yes/no) of Maintaining ≥80% of the BW Reduction Achieved During the 60-week Weight-Loss Period
Description
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.
Time Frame
Week 112
Title
Number of Participants with an Assessment of (yes/no) of Maintaining ≥ 15% BW Reduction for Participants Who Have Already Lost ≥15% BW at Randomization
Description
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.
Time Frame
Week 112
Title
Percent Change from Baseline in Body Weight
Time Frame
Baseline (Week 0), Week 112
Title
Change from Randomization in Body Weight
Time Frame
Week 60, Week 112
Title
Percent Change from Randomization in Body Weight
Time Frame
Week 60, Week 112
Title
Change from Randomization in Waist Circumference
Time Frame
Week 60, Week 112
Title
Percent Maintenance of BW Reduction Achieved During the 60-week Weight-Loss Period
Time Frame
Week 84

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Phone
1-317-615-4559
Email
ClinicalTrials.gov@lilly.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Cahaba Research - Pelham
City
Pelham
State/Province
Alabama
ZIP/Postal Code
35124
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Vaughn
Facility Name
National Research Institute - Wilshire
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
213-483-1800
First Name & Middle Initial & Last Name & Degree
David Guzman
Facility Name
Southern California Dermatology, Inc.
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wayne Ho
Facility Name
Encompass Clinical Research
City
Spring Valley
State/Province
California
ZIP/Postal Code
91978
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanid Audish
Facility Name
New Horizon Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lazaro D. Nunez
Facility Name
Oviedo Medical Research
City
Oviedo
State/Province
Florida
ZIP/Postal Code
32765
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bradley M. Block
Facility Name
Rophe Adult and Pediatric Medicine/SKYCRNG
City
Union City
State/Province
Georgia
ZIP/Postal Code
30291
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
470-317-3604
First Name & Middle Initial & Last Name & Degree
Dwight Blake
Facility Name
East-West Medical Research Institute
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
8085316886
First Name & Middle Initial & Last Name & Degree
Cindy H. T. Pau
Facility Name
Rocky Mountain Clinical Research
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin T Prier
Facility Name
Asha Clinical Research - Munster
City
Hammond
State/Province
Indiana
ZIP/Postal Code
46324
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohan K. B. Kesani
Facility Name
Iowa Diabetes and Endocrinology Research Center
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
515-329-6800
First Name & Middle Initial & Last Name & Degree
Anuj Bhargava
Facility Name
L-MARC Research Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
502-515-5672
First Name & Middle Initial & Last Name & Degree
Harold E. Bays
Facility Name
Prime Health and Wellness/SKYCRNG
City
Fayette
State/Province
Mississippi
ZIP/Postal Code
39069
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James B. Hall, MD
Facility Name
Alliance for Multispecialty Research, LLC
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73069
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
405-701-8999
First Name & Middle Initial & Last Name & Degree
Lisa Connery
Facility Name
The University of Texas Health Science Center at Houston
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
7134861350
First Name & Middle Initial & Last Name & Degree
Deborah Bade Horn
Facility Name
Dallas Diabetes Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
972-566-7799
First Name & Middle Initial & Last Name & Degree
Julio Rosenstock
Facility Name
Southern Endocrinology Associates
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75149
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
214-693-0904
First Name & Middle Initial & Last Name & Degree
Sumana Gangi
Facility Name
Pinnacle Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madhavi Rudraraju

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
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.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
http://vivli.org/
Links:
URL
https://trials.lilly.com/en-US/trial/424336
Description
A Study of LY3298176 (Tirzepatide) For the Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities

Learn more about this trial

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

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