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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Conditions de participation
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Sexe:
ALL -
Âges admissibles:
45 and up
Critères de 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
Lieu de l'étude
SMH Cardiology Clinical Trials
SMH Cardiology Clinical TrialsSurrey, British Columbia
Canada
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Care Access - Cape Breton
Care Access - Cape BretonSydney, Nova Scotia
Canada
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Victoria Hospital & Children's Hospital - London Health Sciences Centre
Victoria Hospital & Children's Hospital - London Health Sciences CentreLondon, Ontario
Canada
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Care Access - Thunder Bay - Barton Street
Care Access - Thunder Bay - Barton StreetThunder Bay, Ontario
Canada
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Winchester District Memorial Hospital
Winchester District Memorial HospitalWinchester, Ontario
Canada
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Ocean West Research Clinic
Ocean West Research ClinicSurrey, British Columbia
Canada
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G A Research Associates
G A Research AssociatesMoncton, New Brunswick
Canada
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St. Joseph's Health Care
St. Joseph's Health CareLondon, Ontario
Canada
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Lakeridge Health
Lakeridge HealthOshawa, Ontario
Canada
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Clinical Research Solutions - Kitchener
Clinical Research Solutions - KitchenerWaterloo, Ontario
Canada
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C-health Research
C-health ResearchCalgary, Alberta
Canada
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Seven Oaks General Hospital
Seven Oaks General HospitalWinnipeg, Manitoba
Canada
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Med Trust Research
Med Trust ResearchCourtice, Ontario
Canada
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Western Centre for Public Health and Family Medicine
Western Centre for Public Health and Family MedicineLondon, Ontario
Canada
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Corcare
CorcareToronto, Ontario
Canada
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Ecogene-21
Ecogene-21Chicoutimi, Quebec
Canada
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C-health
C-healthEdmonton, Alberta
Canada
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Winnipeg Clinic
Winnipeg ClinicWinnipeg, Manitoba
Canada
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St Josephs Healthcare Hamilton - West 5th Campus
St Josephs Healthcare Hamilton - West 5th CampusHamilton, Ontario
Canada
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North York Diagnostic and Cardiac Centre
North York Diagnostic and Cardiac CentreNorth York, Ontario
Canada
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Toronto General Hospital
Toronto General HospitalToronto, Ontario
Canada
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Unité de Recherche Clinique du CISSS des Laurentides
Unité de Recherche Clinique du CISSS des LaurentidesSt-Jerome, Quebec
Canada
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- Étude parrainée par
- Eli Lilly and Company
- Participants recherchés
- Plus d'informations
- ID de l'étude:
NCT06383390