Clinical trial

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

Opening soon · Phase 3 · 0 countries · Registry ID NCT07738276

Opening soonPhase 3Interventional

What this study is about

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

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionHeart Failure and Reduced Ejection Fraction, Obesity & Overweight, Tirzepatide

Full registry 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

Treatments and study arms

Tirzepatide

Drug

dual GLP-1/GIP receptor agonist administered subcutaneously; brief dosing summary

Placebo

Drug

Matching placebo pen containing all inactive ingredients except tirzepatide

Primary outcomes

Change in 6-Minute Walk DistanceBaseline and 6 months after intervention start

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.

Study locations

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No public site location was included in this record. Check the original registry for updates.