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

Chronic Kidney Disease (CKD) | Atherosclerotic Cardiovascular Disease (ASCVD)

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.

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Participation Requirements

  • Sex:

    ALL
  • Eligible Ages:

    45 and up

Participation Criteria

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

Study Location

SMH Cardiology Clinical Trials
SMH Cardiology Clinical Trials
Surrey, British Columbia
Canada

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Care Access - Cape Breton
Care Access - Cape Breton
Sydney, Nova Scotia
Canada

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Victoria Hospital & Children's Hospital - London Health Sciences Centre
Victoria Hospital & Children's Hospital - London Health Sciences Centre
London, Ontario
Canada

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Care Access - Thunder Bay - Barton Street
Care Access - Thunder Bay - Barton Street
Thunder Bay, Ontario
Canada

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Winchester District Memorial Hospital
Winchester District Memorial Hospital
Winchester, Ontario
Canada

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Ocean West Research Clinic
Ocean West Research Clinic
Surrey, British Columbia
Canada

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G A Research Associates
G A Research Associates
Moncton, New Brunswick
Canada

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St. Joseph's Health Care
St. Joseph's Health Care
London, Ontario
Canada

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Lakeridge Health
Lakeridge Health
Oshawa, Ontario
Canada

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Clinical Research Solutions - Kitchener
Clinical Research Solutions - Kitchener
Waterloo, Ontario
Canada

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C-health Research
C-health Research
Calgary, Alberta
Canada

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Seven Oaks General Hospital
Seven Oaks General Hospital
Winnipeg, Manitoba
Canada

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Med Trust Research
Med Trust Research
Courtice, Ontario
Canada

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Western Centre for Public Health and Family Medicine
Western Centre for Public Health and Family Medicine
London, Ontario
Canada

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Corcare
Corcare
Toronto, Ontario
Canada

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Ecogene-21
Ecogene-21
Chicoutimi, Quebec
Canada

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C-health
C-health
Edmonton, Alberta
Canada

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Winnipeg Clinic
Winnipeg Clinic
Winnipeg, Manitoba
Canada

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St Josephs Healthcare Hamilton - West 5th Campus
St Josephs Healthcare Hamilton - West 5th Campus
Hamilton, Ontario
Canada

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North York Diagnostic and Cardiac Centre
North York Diagnostic and Cardiac Centre
North York, Ontario
Canada

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Toronto General Hospital
Toronto General Hospital
Toronto, Ontario
Canada

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Unité de Recherche Clinique du CISSS des Laurentides
Unité de Recherche Clinique du CISSS des Laurentides
St-Jerome, Quebec
Canada

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Study Sponsored By
Eli Lilly and Company
Participants Required
More Information
Study ID: NCT06383390