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

Description

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.

Conditions

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

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

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

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

Condition
Atherosclerotic Cardiovascular Disease (ASCVD)
Intervention / Treatment

-

Contacts and Locations

Birmingham

Central Research Associates, Birmingham, Alabama, United States, 35205

Daphne

Alliance for Multispecialty Research, LLC, Daphne, Alabama, United States, 36526

Huntsville

Nephrology Consultants, Huntsville, Alabama, United States, 35805

Mobile

Alliance for Multispecialty Research, LLC, Mobile, Alabama, United States, 36608

Gilbert

Prime Medical Group, LLC dba Gilbert Center for Family Medicine, LLC, Gilbert, Arizona, United States, 85296

Paradise Valley

Helios Clinical Research - SAZ-PDV-026, Paradise Valley, Arizona, United States, 85253

Peoria

AMZERN Clinical Trial Organization, Peoria, Arizona, United States, 85381

Phoenix

Banner University Medical Center Phoenix, Phoenix, Arizona, United States, 85006

Phoenix

Phoenix Clinical LLC, Phoenix, Arizona, United States, 85014

Phoenix

Arizona Cardiovascular Research Center, Phoenix, Arizona, United States, 85016

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * Participants have Type 1 Diabetes or any history of diabetic ketoacidosis
  • * 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
  • * 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
  • * 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

Ages Eligible for Study

45 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Eli Lilly and Company,

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), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

2029-02