A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Maridebart Cafraglutide on Mortality and Morbidity in Participants Living With Obesity and Heart Failure
A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Maridebart Cafraglutide on Mortality and Morbidity in Participants Living With Obesity and Heart Failure
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Clinical Trial Information
Trial Contact: Ngo, George M.; Velez Vanessa; Harms, Gabrielle T; Marquart, Vashnie
Trial Phone: 3218439657 ; (321) 843-5390 ; 4077012135 ; 321-843-1037
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IRB No: S25.058.03.
Protocol Abbrev: AMG133
Principal Investigator: Vijaykumar S Kasi, MD, PhD
Phase: Drug: Phase III
Age Group: Adult
Secondary Protocol No: 20230227
Treatment: maridebart cafraglutide or placebo
Therapies Involved: Medication
ClinicalTrials.gov ID: NCT06660173
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Objective
To demonstrate that maridebart cafraglutide is superior to placebo on the composite endpoint of heart failure events (HFE) or death from cardiovascular disease in participants with heart failure (HF) with preserved and mildly reduced ejection fraction (HFpEF and HFmrEF) and a body mass index (BMI) ≥ 30 kg/m2
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Key Eligibility
BMI ≥ 30 kg/m2 and heart failure (HF) with preserved, and mildly reduced ejection fraction.
