This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05822830
Recruitment Status : Active, not recruiting
First Posted : April 21, 2023
Last Update Posted : March 7, 2024
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE September 16, 2022
First Posted Date  ICMJE April 21, 2023
Last Update Posted Date March 7, 2024
Actual Study Start Date  ICMJE April 21, 2023
Estimated Primary Completion Date November 6, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2023)
Percent Change from Baseline in Body Weight [ Time Frame: Baseline, Week 72 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2023)
  • Percentage of Participants Who Achieve ≥10% Body Weight Reduction [ Time Frame: Week 72 ]
  • Percentage of Participants Who Achieve ≥15% Body Weight Reduction [ Time Frame: Week 72 ]
  • Percentage of Participants Who Achieve ≥20% Body Weight Reduction [ Time Frame: Week 72 ]
  • Percentage of Participants Who Achieve ≥25% Body Weight Reduction [ Time Frame: Week 72 ]
  • Change from Baseline in Waist Circumference in Centimeter (cm) [ Time Frame: Baseline, Week 72 ]
  • Percentage of Participants Who Achieve ≥30% Body Weight Reduction [ Time Frame: Week 72 ]
  • Change from Baseline in Body Mass Index (BMI) [ Time Frame: Baseline, Week 72 ]
  • Percent Change from Baseline in Body Weight comparing tirzepatide 15 mg and semaglutide 2.4 mg [ Time Frame: Baseline, Week 72 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2023)
  • Percentage of Participants Who Achieve ≥10% Body Weight Reduction [ Time Frame: Week 72 ]
  • Percentage of Participants Who Achieve ≥15% Body Weight Reduction [ Time Frame: Week 72 ]
  • Percentage of Participants Who Achieve ≥20% Body Weight Reduction [ Time Frame: Week 72 ]
  • Percentage of Participants Who Achieve ≥25% Body Weight Reduction [ Time Frame: Week 72 ]
  • Change from Baseline in Weight Circumference in Centimeter (cm) [ Time Frame: Baseline, Week 72 ]
  • Percentage of Participants Who Achieve ≥30% Body Weight Reduction [ Time Frame: Week 72 ]
  • Change from Baseline in Body Mass Index (BMI) [ Time Frame: Baseline, Week 72 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight With Weight Related Comorbidities
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Phase 3b
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Obesity
  • Overweight
Intervention  ICMJE
  • Drug: Tirzepatide
    Administered SC
    Other Name: LY3298176
  • Drug: Semaglutide
    Administered SC
Study Arms  ICMJE
  • Experimental: Tirzepatide
    Participants will receive tirzepatide subcutaneously (SC).
    Intervention: Drug: Tirzepatide
  • Active Comparator: Semaglutide
    Participants will receive semaglutide SC.
    Intervention: Drug: Semaglutide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: April 10, 2023)
700
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 6, 2024
Estimated Primary Completion Date November 6, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Puerto Rico,   United States
Removed Location Countries Argentina,   Belgium,   Brazil,   Canada,   Germany,   Poland,   United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT05822830
Other Study ID Numbers  ICMJE 17203
I8F-MC-GPHJ ( Other Identifier: Eli Lilly and Company )
U1111-1283-5404 ( Other Identifier: UTN Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
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.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: http://vivli.org
Current Responsible Party Eli Lilly and Company
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Eli Lilly and Company
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date March 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP