A Phase 3 interventional study of Tirzepatide and Placebo in Heart Failure and Reduced Ejection Fraction, Obesity & Overweight and Tirzepatide, sponsored by Shahid Beheshti University of Medical Sciences. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-03.
Sponsored by Shahid Beheshti University of Medical Sciences · Phase 3, Interventional, and Treatment
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
This is a phase 3, randomized, double-blind (participant, care provider, investigator, and outcomes assessor blinded), placebo-controlled, parallel- group clinical trial evaluating the efficacy and safety of tirzepatide, a dual glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptor agonist, in participants with heart failure with reduced ejection fraction (HFrEF) and obesity.
Eligible participants are adults aged 18 years or older with HFrEF (left ventricular ejection fraction ≤40% on echocardiography within the prior 3 months), a body mass index ≥27 kg/m² with at least one obesity-related comorbidity (hypertension, diabetes, or dyslipidemia), and stable guideline-directed heart failure therapy for at least 4 weeks prior to enrollment. Key exclusion criteria include recent acute heart failure decompensation or hospitalization, uncontrolled blood pressure, advanced kidney disease (eGFR \<30 mL/min/1.73m²), significant hepatic impairment, active pancreatitis, personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2, and pregnancy or breastfeeding.
A total of 60 participants will be randomized 1:1 using a computer-generated block randomization schedule (block size of 4) to receive either tirzepatide or matching placebo, both administered as weekly subcutaneous injections. Study drug is initiated at 2.5 mg once weekly and titrated every 4 weeks, as tolerated, up to a maximum of 10 mg once weekly, continuing through month 6. The placebo pen is identical in appearance, packaging, and dosing schedule to maintain blinding.
The primary outcome is change in 6-minute walk distance from baseline to 6 months. Secondary outcomes include change in New York Heart Association functional class, Kansas City Cardiomyopathy Questionnaire quality-of-life score, body mass index, ejection fraction, pulmonary artery pressure, and metabolic parameters (fasting glucose, glycated hemoglobin, lipid panel), measured at baseline and at months 2, 4, and 6. Safety outcomes include gastrointestinal adverse events, injection-site reactions, hypoglycemia, pancreatitis, gallbladder events, and changes in liver enzymes, amylase, and lipase. An exploratory outcome evaluates shared molecular and genetic pathways linking obesity and HFrEF using peripheral blood RNA analysis via quantitative PCR or next-generation sequencing.
The study is being conducted at seven sites in Tehran, Iran, including Masih Daneshvari Hospital, Shahid Rajaei Cardiovascular Medical and Research Center, Rasoul Akram Hospital, Tehran Heart Center, Firoozgar Hospital, Ayatollah Taleghani Hospital, and Imam Khomeini Hospital Complex.
230 studies on the registry are indexed under Heart Failure, Systolic; 51 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 165 interventional studies indexed under Heart Failure, Systolic.
Browse Heart Failure, Systolic studies →Shahid Beheshti University of Medical Sciences is the lead sponsor of 229 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Tirzepatide
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.
Drug: Placebo
dual GLP-1/GIP receptor agonist administered subcutaneously; brief dosing summary
Also known as: Spartina
Matching placebo pen containing all inactive ingredients except tirzepatide
Also known as: Spartina
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.
Time frame: Baseline and 6 months after intervention start
NYHA Functional Class
Heart failure severity classified according to the New York Heart Association (NYHA) functional classification system.
Time frame: Baseline and 6 months after intervention start
Glycated Hemoglobin (HbA1c)
Measured using standard biochemical assay kit.
Time frame: Baseline, end of month 2, end of month 4, and end of month 6
Fasting Blood Glucose
Venous blood sample collected after at least 8 hours of fasting; fasting glucose measured using standard enzymatic glucose oxidase laboratory kit.
Time frame: Baseline, end of month 2, end of month 4, and end of month 6
Body Mass Index (BMI)
Calculated as weight in kilograms divided by height in meters squared, using standardized stadiometer and scale.
Time frame: Baseline and 6 months after intervention start
Quality of Life (QoL)
Assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ) score.
Time frame: Baseline and 6 months after intervention start
Systolic Blood Pressure
Measured using a calibrated automatic blood pressure device after at least 5 minutes of rest in a seated position.
Time frame: Baseline, end of month 2, end of month 4, and end of month 6
Serum Amylase
Venous blood sample; serum amylase measured using standard colorimetric enzymatic laboratory kit.
Time frame: Baseline, end of month 2, end of month 4, and end of month 6
Alanine Aminotransferase (ALT)
Venous blood sample; serum ALT measured using standard enzymatic spectrophotometric laboratory kit.
Time frame: Baseline, end of month 2, end of month 4, and end of month 6
N-terminal Pro B-type Natriuretic Peptide (NT-proBNP)
Measured using human NT-proBNP ELISA kit.
Time frame: Baseline, end of month 2, end of month 4, and end of month 6
Total Cholesterol
Venous blood sample collected after at least 8 hours of fasting; total cholesterol measured using standard colorimetric enzymatic laboratory kit.
Time frame: Baseline, end of month 2, end of month 4, and end of month 6
Ejection Fraction
Assessed by echocardiography.
Time frame: Baseline, end of month 2, end of month 4, and end of month 6
Number of Participants With Gallbladder Problems
Gallbladder problems (gallstones or cholecystitis) confirmed by abdominal ultrasound.
Time frame: Baseline, end of month 2, end of month 4, and end of month 6
Number of Participants With Hypoglycemia
Hypoglycemia, defined as blood glucose below 70 mg/dL, measured using standard enzymatic glucose oxidase laboratory kit.
Time frame: Baseline, end of month 2, end of month 4, and end of month 6
Number of Participants With Injection Site Reactions
Injection site reactions (including redness, swelling, itching, or pain at the injection site) assessed by physical examination.
Time frame: Baseline, end of month 2, end of month 4, and end of month 6
Number of Participants With Gastrointestinal Adverse Events
Gastrointestinal adverse events (including nausea, vomiting, diarrhea, constipation, or abdominal pain) graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, and assessed through participant interview and monitoring form.
Time frame: Baseline, end of month 2, end of month 4, and end of month 6
Number of Participants With Pancreatitis
Pancreatitis diagnosed according to the revised Atlanta classification criteria, requiring at least two of the following: characteristic abdominal pain, serum amylase or lipase greater than three times the upper limit of normal, or characteristic findings on abdominal imaging.
Time frame: Baseline, end of month 2, end of month 4, and end of month 6
Number of Participants With Tachycardia
Tachycardia, defined as a resting heart rate greater than 100 beats per minute measured by pulse oximetry or ECG monitoring at scheduled study visits.
Time frame: Baseline, end of month 2, end of month 4, and end of month 6
Diastolic Blood Pressure
Measured using a calibrated automatic blood pressure device after at least 5 minutes of rest in a seated position.
Time frame: Baseline, end of month 2, end of month 4, and end of month 6
Serum Lipase
Venous blood sample; serum lipase measured using standard colorimetric enzymatic laboratory kit.
Time frame: Baseline, end of month 2, end of month 4, and end of month 6
Aspartate Aminotransferase (AST)
Venous blood sample; serum AST measured using standard enzymatic spectrophotometric laboratory kit.
Time frame: Baseline, end of month 2, end of month 4, and end of month 6
Alkaline Phosphatase
Venous blood sample; serum alkaline phosphatase measured using standard enzymatic spectrophotometric laboratory kit.
Time frame: Baseline, end of month 2, end of month 4, and end of month 6
Low-Density Lipoprotein (LDL)
Venous blood sample collected after at least 8 hours of fasting; serum LDL measured using standard colorimetric enzymatic laboratory kit.
Time frame: Baseline, end of month 2, end of month 4, and end of month 6
High-Density Lipoprotein (HDL)
Venous blood sample collected after at least 8 hours of fasting; serum HDL measured using standard colorimetric enzymatic laboratory kit.
Time frame: Baseline, end of month 2, end of month 4, and end of month 6
Triglycerides
Venous blood sample collected after at least 8 hours of fasting; serum triglycerides measured using standard colorimetric enzymatic laboratory kit at the central laboratory.
Time frame: Baseline, end of month 2, end of month 4, and end of month 6
Pulmonary Artery Pressure
Assessed by echocardiography.
Time frame: Baseline, end of month 2, end of month 4, and end of month 6
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).
Time frame: Baseline and 6 months after intervention start
No study locations are listed for this record.
Start is estimated for Jul 2026; primary completion for Jun 2027, 10 months later.
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This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tirzepatide
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