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
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 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.
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:
A Body Mass Index of ≥27.0 kilograms per meter squared (kg/m^2)
Exclusion Criteria:
Diabetes related:
CV related:
Participants have any of the following cardiovascular conditions ≤ 90 days prior to randomization:
Have acute decompensated heart failure requiring hospitalization.
Have New York Heart Association (NYHA) Classification Class IV heart failure at screening
Kidney related:
Other medical conditions:
Gilbert, Arizona 85296, United States
Glendale, Arizona 85306, United States
Sun City West, Arizona 85375, United States
Toluca Lake, California 91602, United States
Torrance, California 90502, United States
Victorville, California 92392, United States
Fort Lauderdale, Florida 33312, United States
Hinsdale, Illinois 60521, United States
Springfield, Illinois 62711, United States
Fort Wayne, Indiana 46804, United States
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Troy, Michigan 48098, United States
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C.a.b.a., C1205AAO, Argentina
CABA, C1060ABN, Argentina
CABA, C1405BCG, Argentina
Capital, X5008HHW, Argentina
Ciudad de Buenos Aires, C1012AAR, Argentina
Rosario, 2000, Argentina
SAN M. de Tucuman, T4000AXL, Argentina
Kluisbergen, 9690, Belgium
Liège, 4000, Belgium
São José do Rio Preto, 15090000, Brazil
North York, M6B 3H7, Canada
Ostrava - Dubina, 700 30, Czechia
Praha 9 - Klanovice, 190 14, Czechia
Bois-Guillaume, 76230, France
Dresden, 01277, Germany
Saint Ingbert, 66386, Germany
Roma, 00168, Italy
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Istanbul, 34668, Turkey (Türkiye)
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Chernivtsi, 58000, Ukraine
Kyiv, 03057, Ukraine
Lancashire, OL6 6EW, United Kingdom