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

• ClinicalTrials.gov Identifier: NCT05882045
• Recruitment Status: Recruiting
• First Posted: May 31, 2023
• Last Update Posted: April 17, 2024
• Sponsor: Eli Lilly and Company
• Information provided by (Responsible Party): Eli Lilly and Company

Tracking Information

• First Submitted Date: May 22, 2023
• First Posted Date: May 31, 2023
• Last Update Posted Date: April 17, 2024
• Actual Study Start Date: May 30, 2023
• Estimated Primary Completion Date: January 20, 2026 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 22, 2023): Percent Change from Baseline in Body Weight [ Time Frame: Baseline, Week 80 ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of Retatrutide (LY3437943) in Participants With Obesity and Cardiovascular Disease
• 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
• 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment

Condition

• Obesity
• Cardiovascular Diseases

Intervention

• Drug: Retatrutide
  Administered SC
  Other Name: LY3437943
• Drug: Placebo
  Administered SC

Study Arms

• 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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 22, 2023): 1800
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: February 17, 2026
• Estimated Primary Completion Date: January 20, 2026 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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: Argentina, Australia, Canada, Hungary, Mexico, Poland, Puerto Rico, Slovakia, Spain, United States

Administrative Information

• NCT Number: NCT05882045
• Other Study ID Numbers: 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

• 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: Eli Lilly and Company
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

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

• PRS Account: Eli Lilly and Company
• Verification Date: April 2024