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The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Renal Function in Adults Living With Obesity (TRIUMPH-OUTCOMES)

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ClinicalTrials.gov Identifier: NCT06383390
Recruitment Status : Not yet recruiting
First Posted : April 25, 2024
Last Update Posted : April 25, 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 determine if retatrutide can significantly lower the incidence of serious heart-related complications or prevent the worsening of kidney function. The trial will enroll adults with body mass index 27 kg/m^2 or higher and Atherosclerotic Cardiovascular Disease and/or chronic kidney disease.

Condition or disease Intervention/treatment Phase
Overweight and Obesity Drug: Retatrutide Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Investigate the Effect of Retatrutide on the Incidence of Major Adverse Cardiovascular Events and the Decline in Kidney Function in Participants With Body Mass Index ≥27 kg/m^2 and Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease.
Estimated Study Start Date : May 2024
Estimated Primary Completion Date : February 2029
Estimated Study Completion Date : February 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arms and Interventions
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Arm Intervention/treatment
Experimental: Retatrutide
Participants will receive escalated doses of retatrutide administered subcutaneously (SC) up to a maximum tolerated dose.
 Drug: Retatrutide
Administered SC
Other Name: LY3437943
Placebo Comparator: Placebo
Participants will receive matching placebo administered SC.
 Drug: Placebo
Administered SC


Outcome Measures
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Primary Outcome Measures :
  1. Time to First Occurrence of Composite Endpoints [ Time Frame: Randomization up to Study Completion (Approximate 248 Weeks) ]
    A composite endpoint includes nonfatal myocardial infarction (MI), nonfatal stroke, cardiovascular (CV) death, or hospitalization or urgent visit due to heart failure (HF).

  2. Time to First Occurrence of Composite Endpoint of End Stage Kidney Disease (ESKD), ≥ 40% Sustained Decline in Estimated Glomerular Filtration Rate (eGFR), CV Death or Renal Death [ Time Frame: Randomization up to Study Completion (Approximate 248 Weeks) ]

    ESKD is defined as the following individual components: persistent eGFR <15 mL/min/1.73 m^2 confirmed by a second measurement at the earliest 4 weeks after the initial measurement at the central laboratory, initiation of dialysis for at least 30 days, receiving a kidney transplant.

    Sustained decline in eGFR (≥40%) will be confirmed by a repeated measure 1 month after the initial result.



Secondary Outcome Measures :
  1. Time to First Occurrence of Composite Endpoint of Major Cardiovascular Events (MACE-3) [ Time Frame: Randomization up to Study Completion (Approximate 248 Weeks) ]
    MACE-3 includes CV death, nonfatal MI, and nonfatal stroke.

  2. Time to First Occurrence of Composite Endpoint of CV death, or hospitalization or urgent visit due to HF [ Time Frame: Randomization up to Study Completion (Approximate 248 Weeks) ]
    Time to First Occurrence of Composite Endpoint of CV death, or hospitalization or urgent visit due to HF.

  3. Time to Occurrence of All-Cause Death [ Time Frame: Randomization up to Study Completion (Approximate 248 Weeks) ]
    Time to all-cause death.

  4. Time to First Occurrence of composite endpoint of ≥ 40% Sustained Decline in eGFR, End-Stage Renal Disease (ESRD), or Renal Death [ Time Frame: Randomization up to Study Completion (Approximate 248 Weeks) ]
  5. Percentage change from Baseline in Albuminuria urinary albumin/creatinine ratio (UACR) in Participants with UACR ≥30 mg/g (0.03 mg/mg) at baseline [ Time Frame: Randomization up to Study Completion (Approximate 248 Weeks) ]

Eligibility Criteria
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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A Body Mass Index of ≥27.0 kilograms per meter squared (kg/m^2)
  • Participants may be with or without type 2 diabetes (T2D) unless their hemoglobin A1c (HbA1c) is 10% or lower

  • Participants have established atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD), as evidenced at least one of the following:

    • Coronary artery disease
    • Cerebrovascular disease
    • Peripheral arterial disease

    • Chronic kidney disease defined as:

      • eGFR <45 millilitres/minute/1.73 meter squared (mL/min/1.73m^2) and UACR >30 milligram/gram (mg/g)
      • eGFR <60 mL/min/1.73 m^2 and UACR >100 mg/g, or
      • eGFR <75 mL/min/1.73 m^2 and UACR >300 mg/g (eGFR is calculated based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) cystatin c equation as determined by central lab)

Exclusion Criteria:

Diabetes related:

  • Participants have Type 1 Diabetes or history of diabetic ketoacidosis

CV related:

  • Participants have any of the following cardiovascular conditions ≤ 90 days prior to randomization:

    • Myocardial infarction
    • Acute coronary syndrome
    • Stroke, or
    • Coronary, peripheral, or carotid artery arterial revascularization procedure.
  • Have acute decompensated heart failure requiring hospitalization.
  • Have New York Heart Association (NYHA) Classification Class IV heart failure at screening

Kidney related:

  • Participants have an eGFR <20 mL/min/1.73 m^2 at screening
  • Have UACR >5000 mg/g at screening
  • Have received any form of dialysis ≤ 90 days from the date of randomization
  • Have either undergone a kidney transplant or have a transplant procedure scheduled

Other medical conditions:

  • Participants have had or plan to have a surgical treatment for obesity,
  • Have a history of chronic or acute pancreatitis
  • Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome type 2
  • Have a known clinically significant gastric emptying abnormality, such as severe gastroparesis or gastric outlet obstruction
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): NCT06383390


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-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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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT06383390    
Other Study ID Numbers: 18584
J1I-MC-GZBO ( Other Identifier: Eli Lilly and Company )
2023-508630-34-00 ( Other Identifier: EU CTR Number )
First Posted: April 25, 2024    Key Record Dates
Last Update Posted: April 25, 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: 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
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Eli Lilly and Company:
Cardiovascular Disease
Kidney Disease
Overweight
Obesity
Major Adverse Cardiovascular Events (MACE)
 Atherosclerotic Cardiovascular Disease (ASCVD)
Renal Outcomes
Cardiovascular Risk Reduction
Kidney Disease Progression
Cardiometabolic Risk Factors
Additional relevant MeSH terms:
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Cardiovascular Diseases
Obesity
Overweight
 Overnutrition
Nutrition Disorders
Body Weight