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A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight With Weight Related Comorbidities (SURMOUNT-5)

Primary Purpose

Obesity, Overweight

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tirzepatide
Semaglutide
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Metabolism and Nutrition, Disorder, Prediabetes, Diet, Exercise

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 per square meter (kg/m²) or ≥27 kg/m² and previously diagnosed with at least one of the following weight related comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease Have a history of at least 1 unsuccessful dietary effort to lose body weight Exclusion Criteria: Diabetes mellitus Change in body weight greater than 5 kg within 3 months prior to starting study Obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity History of pancreatitis 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

Sites / Locations

  • Cahaba Research
  • Cahaba Research - Pelham
  • Southern California Dermatology, Inc.
  • Encompass Clinical Research
  • University Clinical Investigators, Inc.
  • MD Clinical
  • New Horizon Research Center
  • ForCare Clinical Research
  • Rophe Adult and Pediatric Medicine/SKYCRNG
  • Rocky Mountain Clinical Research
  • Iowa Diabetes and Endocrinology Research Center
  • L-MARC Research Center
  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
  • SKY Clinical Research Network Group - Hall
  • StudyMetrix Research
  • Palm Research Center Tenaya
  • Palm Research Center Sunset
  • Weill Cornell Medical College
  • PharmQuest
  • Lillestol Research
  • Intend Research, LLC
  • Tribe Clinical Research, LLC
  • WR-Clinsearch, LLC
  • The University of Texas Health Science Center at Houston
  • Dallas Diabetes Research Center
  • North Texas Endocrine Center
  • Biopharma Informatic, LLC
  • Endocrine Ips, Pllc
  • Southern Endocrinology Associates
  • Pinnacle Clinical Research
  • Puerto Rico Medical Research
  • Wellness clinical Research Vega Baja

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tirzepatide

Semaglutide

Arm Description

Participants will receive tirzepatide subcutaneously (SC).

Participants will receive semaglutide SC.

Outcomes

Primary Outcome Measures

Percent Change from Baseline in Body Weight

Secondary Outcome Measures

Percentage of Participants Who Achieve ≥10% Body Weight Reduction
Percentage of Participants Who Achieve ≥15% Body Weight Reduction
Percentage of Participants Who Achieve ≥20% Body Weight Reduction
Percentage of Participants Who Achieve ≥25% Body Weight Reduction
Change from Baseline in Waist Circumference in Centimeter (cm)
Percentage of Participants Who Achieve ≥30% Body Weight Reduction
Change from Baseline in Body Mass Index (BMI)
Percent Change from Baseline in Body Weight comparing tirzepatide 15 mg and semaglutide 2.4 mg

Full Information

First Posted
September 16, 2022
Last Updated
October 23, 2023
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT05822830
Brief Title
A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight With Weight Related Comorbidities
Acronym
SURMOUNT-5
Official Title
A Phase 3b, Randomized Controlled Study to Evaluate the Efficacy and Safety of Tirzepatide Compared to Semaglutide in Adults Who Have Obesity or Overweight With Weight Related Comorbidities
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 21, 2023 (Actual)
Primary Completion Date
November 6, 2024 (Anticipated)
Study Completion Date
November 6, 2024 (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 phase 3b study is to evaluate the efficacy and safety of tirzepatide compared with semaglutide in adult participants who have obesity or overweight with weight related comorbidities without Type 2 Diabetes. The study will last around 74 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight
Keywords
Metabolism and Nutrition, Disorder, Prediabetes, Diet, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Phase 3b
Masking
None (Open Label)
Allocation
Randomized
Enrollment
700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tirzepatide
Arm Type
Experimental
Arm Description
Participants will receive tirzepatide subcutaneously (SC).
Arm Title
Semaglutide
Arm Type
Active Comparator
Arm Description
Participants will receive semaglutide SC.
Intervention Type
Drug
Intervention Name(s)
Tirzepatide
Other Intervention Name(s)
LY3298176
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Semaglutide
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Percent Change from Baseline in Body Weight
Time Frame
Baseline, Week 72
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Achieve ≥10% Body Weight Reduction
Time Frame
Week 72
Title
Percentage of Participants Who Achieve ≥15% Body Weight Reduction
Time Frame
Week 72
Title
Percentage of Participants Who Achieve ≥20% Body Weight Reduction
Time Frame
Week 72
Title
Percentage of Participants Who Achieve ≥25% Body Weight Reduction
Time Frame
Week 72
Title
Change from Baseline in Waist Circumference in Centimeter (cm)
Time Frame
Baseline, Week 72
Title
Percentage of Participants Who Achieve ≥30% Body Weight Reduction
Time Frame
Week 72
Title
Change from Baseline in Body Mass Index (BMI)
Time Frame
Baseline, Week 72
Title
Percent Change from Baseline in Body Weight comparing tirzepatide 15 mg and semaglutide 2.4 mg
Time Frame
Baseline, Week 72

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 per square meter (kg/m²) or ≥27 kg/m² and previously diagnosed with at least one of the following weight related comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease Have a history of at least 1 unsuccessful dietary effort to lose body weight Exclusion Criteria: Diabetes mellitus Change in body weight greater than 5 kg within 3 months prior to starting study Obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity History of pancreatitis 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
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
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35242
Country
United States
Facility Name
Cahaba Research - Pelham
City
Pelham
State/Province
Alabama
ZIP/Postal Code
35124
Country
United States
Facility Name
Southern California Dermatology, Inc.
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
Facility Name
Encompass Clinical Research
City
Spring Valley
State/Province
California
ZIP/Postal Code
91978
Country
United States
Facility Name
University Clinical Investigators, Inc.
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
MD Clinical
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
New Horizon Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
ForCare Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613-1244
Country
United States
Facility Name
Rophe Adult and Pediatric Medicine/SKYCRNG
City
Union City
State/Province
Georgia
ZIP/Postal Code
30291
Country
United States
Facility Name
Rocky Mountain Clinical Research
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Iowa Diabetes and Endocrinology Research Center
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Facility Name
L-MARC Research Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Facility Name
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
SKY Clinical Research Network Group - Hall
City
Fayette
State/Province
Mississippi
ZIP/Postal Code
39069
Country
United States
Facility Name
StudyMetrix Research
City
Saint Peters
State/Province
Missouri
ZIP/Postal Code
63303
Country
United States
Facility Name
Palm Research Center Tenaya
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Palm Research Center Sunset
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
PharmQuest
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Lillestol Research
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Facility Name
Intend Research, LLC
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73069
Country
United States
Facility Name
Tribe Clinical Research, LLC
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
WR-Clinsearch, LLC
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37397
Country
United States
Facility Name
The University of Texas Health Science Center at Houston
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
Dallas Diabetes Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
North Texas Endocrine Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Biopharma Informatic, LLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77043
Country
United States
Facility Name
Endocrine Ips, Pllc
City
Houston
State/Province
Texas
ZIP/Postal Code
77079
Country
United States
Facility Name
Southern Endocrinology Associates
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75149
Country
United States
Facility Name
Pinnacle Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Puerto Rico Medical Research
City
Ponce
ZIP/Postal Code
00717
Country
Puerto Rico
Facility Name
Wellness clinical Research Vega Baja
City
Vega Baja
ZIP/Postal Code
00694
Country
Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized individual patient 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/399775
Description
A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight With Weight Related Comorbidities (SURMOUNT-5)

Learn more about this trial

A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight With Weight Related Comorbidities

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