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A Study of Retatrutide (LY3437943) in Participants With Obesity and Cardiovascular Disease (TRIUMPH-3)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05882045
Recruitment Status : Recruiting
First Posted : May 31, 2023
Last Update Posted : October 19, 2023
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE May 22, 2023
First Posted Date  ICMJE May 31, 2023
Last Update Posted Date October 19, 2023
Actual Study Start Date  ICMJE May 30, 2023
Estimated Primary Completion Date January 20, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2023)
Percent Change from Baseline in Body Weight [ Time Frame: Baseline, Week 80 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2023)
  • Change from Baseline in Body Mass Index (BMI) [ Time Frame: Baseline, Week 80 ]
  • Change from Baseline in Waist Circumference [ Time Frame: Baseline, Week 80 ]
  • Percent Change from Baseline in Total Cholesterol [ Time Frame: Baseline, Week 80 ]
  • Percent Change from Baseline in Triglycerides [ Time Frame: Baseline, Week 80 ]
  • Change from Baseline in Systolic Blood Pressure (SBP) [ Time Frame: Baseline, Week 80 ]
  • Change from Baseline in Diastolic Blood Pressure (DBP) [ Time Frame: Baseline, Week 80 ]
  • Change from Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, Week 80 ]
  • Percent Change from Baseline in Fasting Insulin [ Time Frame: Baseline, Week 80 ]
  • Change from Baseline in Short Form version 2 (SF-36v2) Acute Form Physical Function Domain Score [ Time Frame: Baseline, Week 80 ]
  • Pharmacokinetics (PK): Steady State Area Under the Concentration Time Cure (AUC) [ Time Frame: Baseline to Week 80 ]
    AUC is presented as a single average measure of AUC across the study duration.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Retatrutide (LY3437943) in Participants With Obesity and Cardiovascular Disease
Official Title  ICMJE A Randomized, Double-Blind, Phase 3 Study to Investigate the Efficacy and Safety of LY3437943 Once Weekly Compared to Placebo in Participants With Severe Obesity and Established Cardiovascular Disease
Brief Summary The main purpose of this study is to evaluate the efficacy and safety of retatrutide once weekly in participants with obesity and established cardiovascular disease (CVD). The study will last about 113 weeks.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Obesity
  • Cardiovascular Diseases
Intervention  ICMJE
  • Drug: Retatrutide
    Administered SC
    Other Name: LY3437943
  • Drug: Placebo
    Administered SC
Study Arms  ICMJE
  • Experimental: Retatrutide Dose 1
    Participants will receive retatrutide subcutaneously (SC).
    Intervention: Drug: Retatrutide
  • Experimental: Retatrutide Dose 2
    Participants will receive retatrutide SC.
    Intervention: Drug: Retatrutide
  • Placebo Comparator: Placebo
    Participants will receive placebo.
    Intervention: Drug: Placebo
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 22, 2023)
1800
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 17, 2026
Estimated Primary Completion Date January 20, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Have a body mass index (BMI) ≥35.0 kilogram/square meter (kg/m²).
  • Have established cardiovascular (CV) disease with at least 1 of the following:

    • prior myocardial infarction
    • prior ischemic or hemorrhagic stroke, or
    • symptomatic peripheral arterial disease
  • Have a history of at least 1 self-reported unsuccessful dietary effort to reduce body weight.

Exclusion Criteria:

  • Have had acute myocardial infarction, stroke, coronary revascularization, hospitalization for unstable angina, or hospitalization due to congestive heart failure within 90 days prior to screening.
  • Have taken weight loss drugs, including over-the-counter medications, within 90 days prior to screening.
  • Have a prior or planned surgical treatment of obesity.
  • Have a change in body weight greater than 5 kg (11 pounds) within 90 days prior to screening.
  • Have Type 1 diabetes.
  • Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
  • Have had pancreatitis.
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: There may be multiple sites in this clinical trial -877-CTLILLY (1-877-285-4559) or 1-317-615-4559 ClinicalTrials.gov@lilly.com
Listed Location Countries  ICMJE Argentina,   Australia,   Canada,   Hungary,   Mexico,   Poland,   Puerto Rico,   Slovakia,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05882045
Other Study ID Numbers  ICMJE 18582
J1I-MC-GZBM ( Other Identifier: Eli Lilly and Company )
2023-503659-88-00 ( Other Identifier: EU Trial Number )
Has Data Monitoring Committee Yes
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 October 2023

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