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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 : April 17, 2024
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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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.

Condition or disease Intervention/treatment Phase
Obesity Cardiovascular Diseases Drug: Retatrutide Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 30, 2023
Estimated Primary Completion Date : January 20, 2026
Estimated Study Completion Date : February 17, 2026
Arms and Interventions
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Arm Intervention/treatment
Experimental: Retatrutide Dose 1
Participants will receive retatrutide subcutaneously (SC).
 Drug: Retatrutide
Administered SC
Other Name: LY3437943
Experimental: Retatrutide Dose 2
Participants will receive retatrutide SC.
 Drug: Retatrutide
Administered SC
Other Name: LY3437943
Placebo Comparator: Placebo
Participants will receive placebo.
 Drug: Placebo
Administered SC


Outcome Measures
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Primary Outcome Measures :
  1. Percent Change from Baseline in Body Weight [ Time Frame: Baseline, Week 80 ]

Secondary Outcome Measures :
  1. Change from Baseline in Body Mass Index (BMI) [ Time Frame: Baseline, Week 80 ]
  2. Change from Baseline in Waist Circumference [ Time Frame: Baseline, Week 80 ]
  3. Percent Change from Baseline in Total Cholesterol [ Time Frame: Baseline, Week 80 ]
  4. Percent Change from Baseline in Triglycerides [ Time Frame: Baseline, Week 80 ]
  5. Change from Baseline in Systolic Blood Pressure (SBP) [ Time Frame: Baseline, Week 80 ]
  6. Change from Baseline in Diastolic Blood Pressure (DBP) [ Time Frame: Baseline, Week 80 ]
  7. Change from Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, Week 80 ]
  8. Percent Change from Baseline in Fasting Insulin [ Time Frame: Baseline, Week 80 ]
  9. Change from Baseline in Short Form version 2 (SF-36v2) Acute Form Physical Function Domain Score [ Time Frame: Baseline, Week 80 ]
  10. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05882045


Contacts
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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

Locations
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Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
More Information
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Additional Information:

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT05882045    
Other Study ID Numbers: 18582
J1I-MC-GZBM ( Other Identifier: Eli Lilly and Company )
2023-503659-88-00 ( Other Identifier: EU Trial Number )
First Posted: May 31, 2023    Key Record Dates
Last Update Posted: April 17, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
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/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiovascular Diseases
Obesity
Overweight
 Overnutrition
Nutrition Disorders
Body Weight