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

March 6, 2024 updated by: Eli Lilly and Company

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

700

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Ponce, Puerto Rico, 00717
        • Puerto Rico Medical Research
      • Vega Baja, Puerto Rico, 00694
        • Wellness clinical Research Vega Baja
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35242
        • Cahaba Research
      • Pelham, Alabama, United States, 35124
        • Cahaba Research - Pelham
    • California
      • Santa Ana, California, United States, 92701
        • Southern California Dermatology, Inc.
      • Spring Valley, California, United States, 91978
        • Encompass Clinical Research
      • Tustin, California, United States, 92780
        • University Clinical Investigators, Inc.
    • Florida
      • Hallandale Beach, Florida, United States, 33009
        • MD Clinical
      • Miami, Florida, United States, 33165
        • New Horizon Research Center
      • Tampa, Florida, United States, 33613-1244
        • Forcare Clinical Research
    • Georgia
      • Union City, Georgia, United States, 30291
        • Rophe Adult and Pediatric Medicine/SKYCRNG
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Rocky Mountain Clinical Research
    • Iowa
      • West Des Moines, Iowa, United States, 50265
        • Iowa Diabetes and Endocrinology Research Center
    • Kentucky
      • Louisville, Kentucky, United States, 40213
        • L-MARC Research Center
    • Michigan
      • Troy, Michigan, United States, 48098
        • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
    • Mississippi
      • Fayette, Mississippi, United States, 39069
        • SKY Clinical Research Network Group - Hall
    • Missouri
      • Saint Peters, Missouri, United States, 63303
        • StudyMetrix Research
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • Palm Research Center Sunset
      • Las Vegas, Nevada, United States, 89128
        • Palm Research Center Tenaya
    • New York
      • New York, New York, United States, 10021
        • Weill Cornell Medical College
    • North Carolina
      • Greensboro, North Carolina, United States, 27408
        • PharmQuest
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Lillestol Research
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Intend Research, LLC
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Tribe Clinical Research, LLC
    • Tennessee
      • Chattanooga, Tennessee, United States, 37397
        • WR-ClinSearch, LLC
    • Texas
      • Bellaire, Texas, United States, 77401
        • The University of Texas Health Science Center at Houston
      • Dallas, Texas, United States, 75230
        • Dallas Diabetes Research Center
      • Dallas, Texas, United States, 75231
        • North Texas Endocrine Center
      • Houston, Texas, United States, 77043
        • Biopharma Informatic, LLC
      • Houston, Texas, United States, 77079
        • Endocrine Ips, Pllc
      • Mesquite, Texas, United States, 75149
        • Southern Endocrinology Associates
      • San Antonio, Texas, United States, 78229
        • Pinnacle Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tirzepatide
Participants will receive tirzepatide subcutaneously (SC).
Drug: Tirzepatide
Administered SC
Other Names:
  • LY3298176
Active Comparator: Semaglutide
Participants will receive semaglutide SC.
Drug: Semaglutide
Administered SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent Change from Baseline in Body Weight
Time Frame: Baseline, Week 72
Baseline, Week 72

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants Who Achieve ≥10% Body Weight Reduction
Time Frame: Week 72
Week 72
Percentage of Participants Who Achieve ≥15% Body Weight Reduction
Time Frame: Week 72
Week 72
Percentage of Participants Who Achieve ≥20% Body Weight Reduction
Time Frame: Week 72
Week 72
Percentage of Participants Who Achieve ≥25% Body Weight Reduction
Time Frame: Week 72
Week 72
Percentage of Participants Who Achieve ≥30% Body Weight Reduction
Time Frame: Week 72
Week 72
Change from Baseline in Body Mass Index (BMI)
Time Frame: Baseline, Week 72
Baseline, Week 72
Change from Baseline in Waist Circumference in Centimeter (cm)
Time Frame: Baseline, Week 72
Baseline, Week 72
Percent Change from Baseline in Body Weight comparing tirzepatide 15 mg and semaglutide 2.4 mg
Time Frame: Baseline, Week 72
Baseline, Week 72

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2023

Primary Completion (Estimated)

November 6, 2024

Study Completion (Estimated)

November 6, 2024

Study Registration Dates

First Submitted

September 16, 2022

First Submitted That Met QC Criteria

April 10, 2023

First Posted (Actual)

April 21, 2023

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17203
  • I8F-MC-GPHJ (Other Identifier: Eli Lilly and Company)
  • U1111-1283-5404 (Other Identifier: UTN Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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 Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on Tirzepatide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Portugal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe