NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Evaluation of the Efficacy and Safety of Tirzepatide, a Dual GLP-1/GIP Agonist, on Functional Capacity in Reduced Ejection Fraction Heart Failure Patients With Obesity

NCT07738276

Not Yet RecruitingPhase 3

Sponsor: Shahid Beheshti University of Medical Sciences

Conditions: Heart Failure and Reduced Ejection Fraction, Obesity & Overweight, Tirzepatide

Interventions: Tirzepatide, Placebo

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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
* Written informed consent

Exclusion Criteria:

* 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)
* Active pancreatitis
* Personal or first-degree family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
* Pregnancy or breastfeeding
* Known hypersensitivity to glucagon-like peptide-1 (GLP-1) or glucose-dependent insulinotropic polypeptide (GIP) receptor agonist drugs
* Concurrent use of other weight-loss medications