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

NCT06383390
clinicaltrials.gov
Phase
Phase 3
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Recruitment status
Active, not recruiting
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Participants
10,000
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Lead sponsor
Eli Lilly and Company
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Start date
2024-04-30
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Number of sites
743
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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. The study will last for about 5 years. Participants will have up to 27 clinic visits with the study doctor.
clinicaltrials.gov
Short title
The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Kidney Outcomes in Adults Living With Obesity (TRIUMPH-Outcomes)
clinicaltrials.gov
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 Major Adverse Kidney Events in Participants With Body Mass Index ≥27 kg/m2 and Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2029-02-01
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First posted
2024-04-25
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Registry last updated
2026-08-24
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Primary completion date
2029-02-01
clinicaltrials.gov
Start date
2024-04-30
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Participants
10,000
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Participant count basis
Estimated
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Planned participants
10,000
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Protocol amendments
3
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Number of sites
743
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Eli Lilly and Company
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06383390
clinicaltrials.gov
ClinicalTrials.gov ID
NCT06383390
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

  1. Time to First Occurrence of Composite Endpoints

    Timeframe: 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

    Timeframe: 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 2 measurements at least 4 weeks apart at the central laboratory, initiation of dialysis for at least 28 days, receiving a kidney transplant. Sustained decline in eGFR (≥40%) will be confirmed by a repeated measure at least 4 weeks after the first result.

  1. Time to First Occurrence of Composite Endpoint of Major Cardiovascular Events (MACE-3)

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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

    Timeframe: Randomization up to Study Completion (Approximate 248 Weeks)

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
45 Years
Healthy volunteers
No

  • Participants may be without type 2 diabetes (T2D), or with T2D if 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) (0.030 mg/mg)
      • eGFR <60 mL/min/1.73 m^2 and UACR >100 mg/g (0.100 mg/mg), or
      • eGFR <75 mL/min/1.73 m^2 and UACR >300 mg/g (0.300 mg/mg) (eGFR is calculated by central lab based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine-cystatin c equation as determined by central lab)

  • A Body Mass Index of ≥27.0 kilograms per meter squared (kg/m^2)

Diabetes related:

  • Participants have Type 1 Diabetes or any 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 (5.000 mg/mg) 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
Sources for eligibility
clinicaltrials.gov

  • Alabama Kidney ResearchAlabaster, United States
  • Central Research AssociatesBirmingham, United States
  • Alliance for Multispecialty Research, LLCDaphne, United States
  • Nephrology ConsultantsHuntsville, United States
  • Alliance for Multispecialty Research, LLCMobile, United States
  • Prime Medical Group, LLC dba Gilbert Center for Family Medicine, LLCGilbert, United States
  • Sun City Clinical ResearchGlendale, United States
  • Arizona Kidney Disease & Hypertension Center (AKDHC) - ThunderbirdGlendale, United States
  • Helios Clinical Research - SAZ-PDV-026Paradise Valley, United States
  • Banner University Medical Center PhoenixPhoenix, United States
  • Phoenix Clinical LLCPhoenix, United States
  • Elite Clinical Studies, LLCPhoenix, United States
  • Absolute Clinical ResearchPhoenix, United States
  • Scottsdale Clinical TrialsScottsdale, United States
  • Clinical Research Institute of Arizona (CRI) - Sun City WestSun City West, United States
  • Synexus Clinical Research US, Inc./Orange Grove Family PracticeTucson, United States
  • Cardiology and Medicine ClinicLittle Rock, United States
  • Trident Clinical Research Services, Inc.Apple Valley, United States
  • Invivo - BakersfieldBakersfield, United States
  • American Institute of ResearchBeverly Hills, United States
  • Hope Clinical Research, Inc.Canoga Park, United States
  • Valley Clinical Trials, Inc.Covina, United States
  • North Coast CardiologyEncinitas, United States
  • Neighborhood Healthcare Institute of HealthEscondido, United States
  • HB Clinical Trials - Fountain ValleyFountain Valley, United States

And 718 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2023
  • 2023-508630-34-00
  • J1I-MC-GZBO
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (10)

Targets (3)