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
Age 18 years or older
Heart failure with reduced ejection fraction, defined as left ventricular ejection fraction ≤40% on echocardiography performed within the prior 3 months
Body mass index ≥27 kg/m², with at least one obesity-related comorbidity (hypertension, diabetes, or dyslipidemia)
Stable heart failure therapy for at least 4 weeks prior to enrollment, including beta-blockers, renin-angiotensin system inhibitors/angiotensin receptor-neprilysin inhibitors, and sodium-glucose cotransporter-2 inhibitors, if prescribed
Acute heart failure decompensation or cardiac hospitalization within the prior 4 weeks
Uncontrolled blood pressure (systolic blood pressure <90 mmHg or ≥180 mmHg)
Advanced renal impairment (estimated glomerular filtration rate <30 mL/min/1.73m²)
Severe hepatic impairment (liver enzymes elevated to 3 times the upper limit of normal)
Parallel
Tirzepatide
Drugdual GLP-1/GIP receptor agonist administered subcutaneously; brief dosing summary
Placebo
DrugMatching placebo pen containing all inactive ingredients except tirzepatide
Change in 6-Minute Walk Distance
The 6-minute walk test will be performed according to the American Thoracic Society standard guidelines in a straight 30-meter corridor. Participants will be asked to walk as far as possible in 6 minutes at their own pace, with rest breaks permitted if needed. Total distance walked will be recorded in meters. This is a standardized, validated, and reproducible tool for assessing functional capacity and exercise tolerance in patients with heart failure.
NYHA Functional Class
Heart failure severity classified according to the New York Heart Association (NYHA) functional classification system.
Glycated Hemoglobin (HbA1c)
Measured using standard biochemical assay kit.
Fasting Blood Glucose
Venous blood sample collected after at least 8 hours of fasting; fasting glucose measured using standard enzymatic glucose oxidase laboratory kit.
Body Mass Index (BMI)
Calculated as weight in kilograms divided by height in meters squared, using standardized stadiometer and scale.
Change in Gene Expression of Obesity- and Heart Failure-Related Pathways
Venous blood sampling before the intervention and at the end of the study, extraction of ribonucleic acid from peripheral blood samples, and assessment of changes in the expression of genes involved in the shared molecular pathways of obesity and Heart Failure with Reduced Ejection Fraction using quantitative real-time polymerase chain reaction (PCR).
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Shahid Beheshti University of Medical Sciences
Lead sponsor
Cinnagen
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
