The goal of this clinical trial is to learn if tirzepatide works to improve physical function in adults with heart failure and obesity. It will also learn about the safety of tirzepatide. The main questions it aims to answer are:
Does tirzepatide improve how far participants can walk in 6 minutes? Does tirzepatide improve heart failure symptoms and quality of life? What side effects do participants have when taking tirzepatide?
Researchers will compare tirzepatide to a placebo (a look-alike substance that contains no drug) to see if tirzepatide improves physical function in people with heart failure and obesity.
Participants will:
Get a weekly injection of tirzepatide or a placebo under the skin for 6 months Start at a low dose, which may be raised slowly based on how well they tolerate it Keep taking their usual heart failure medicines Visit the clinic for checkups, blood tests, heart ultrasounds, and a 6-minute walk test Answer questions about their quality of life and heart failure symptoms
Inclusion Criteria:
Exclusion Criteria:
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The Data Safety Monitoring Committee is also blinded to group allocation throughout the study. In cases of safety-related emergencies, participants will be discontinued from the study.
Participants receive tirzepatide via prefilled subcutaneous injection pen once weekly, in addition to standard heart failure therapy. Starting dose is 2.5 mg once weekly for 4 weeks, titrated based on tolerability every 4 weeks up to a maximum of 10 mg once weekly, continued through month 6.
Participants receive matching placebo via identical prefilled subcutaneous injection pen once weekly, in addition to standard heart failure therapy, with the same dosing schedule and titration pattern as the tirzepatide group, continued through month 6.
Tirzepatide: Reversal of Lipotoxicity and Adipose Tissue Dysfunction in Humans With Overweight/Obesity
Effect of Tirzepatide on Cardiovascular and Metabolic Parameters in Obese Adult Patients With Congenital Heart Disease
Effects of Tirzepatide on Muscle and Vascular Health in Obese Older Adults
Tirzepatide and Muscle Outcomes in Obesity
The Effect of Exercise and Tirzepatide on Weight and Health Outcomes (EXER-MED)
A Study of Tirzepatide (LY3298176) on the Reduction on Morbidity and Mortality in Adults With Obesity
Effectiveness of Combined GLP-1/GIP Dual Agonist Therapy and Structured Exercise on Skeletal Muscle Morphology, Quality, and Physical Function in Overweight and Obese Individuals
GLP-1s to Enhance Lasting Optimal Weight