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Active, Not Recruiting

NCT Number: NCT06383390

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Atherosclerotic Cardiovascular Disease (ASCVD) Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Chronic Disease Chronic Kidney Disease (CKD) Coronary Artery Disease Coronary Disease Death Diabetes Mellitus Diabetes Mellitus, Type 2 Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Heart Diseases Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Metabolic Diseases Myocardial Ischemia Nervous System Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Buenos Aires Macula S.A, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

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

Treatment and study plan

Retatrutide

Drug

Administered SC

Other names: LY3437943

Placebo

Drug

Administered SC

Primary outcomes

  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 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.

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Apr 25, 2024
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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