NCT07738276Not yet recruitingPhase 3
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
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: A Double-Blinded Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 3 Aug 2026
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 27 Jul 2026
- Start date
- 18 Jul 2026
- Primary completion date
- 11 Jun 2027
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Diseases
- Heart failure, Obesity
- NCT number
- NCT07738276
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 60
- From 18 Jul 2026 to the primary completion date, 11 Jun 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Acute heart failure decompensation or cardiac hospitalization within the prior 4 weeks
- Concurrent use of other weight-loss medications
Other illness
- 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)
- Personal or first-degree family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
Lab values
- Known hypersensitivity to glucagon-like peptide-1 (GLP-1) or glucose-dependent insulinotropic polypeptide (GIP) receptor agonist drugs
Other
- Uncontrolled blood pressure (systolic blood pressure \<90 mmHg or ≥180 mmHg)
- Active pancreatitis
- Pregnancy or breastfeeding
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.