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Trial · Interventional

Not yet recruitingPhase 3Registry data

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

Short name DUAL-HFrEF

NCTNCT07738276 (opens ClinicalTrials.gov in a new tab)Other idIRCT20200209046427N3
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Not yet recruiting
Phase
Phase 3
Enrollment
60 participants (estimated)
Sponsor
Shahid Beheshti University of Medical Sciences · Other
Design
Randomized · Quadruple masking
Countries
Not stated
Start
18 Jul 2026 (estimated)
Primary completion
11 Jun 2027 (estimated)
Completion
22 Dec 2027 (estimated)
First posted
31 Jul 2026
Last update posted
3 Aug 2026
Conditions
Heart Failure and Reduced Ejection Fraction · Obesity & Overweight · Tirzepatide

Timeline

1 trial · 1 not yet recruiting

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202620272028
  1. Ph 3

    DUAL-HFrEF

    NCT07738276

    est. 18 Jul 2026 to est. 22 Dec 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • TirzepatideDrug
  • PlaceboDrug

Arms2

  • Experimental

    Tirzepatide

    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.

  • Placebo comparator

    Placebo

    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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in 6-Minute Walk Distance

    Time frame · Baseline and 6 months after intervention start

    Registry description

    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.

Secondary outcomes(20)

  1. NYHA Functional Class

    Time frame · Baseline and 6 months after intervention start

    Registry description

    Heart failure severity classified according to the New York Heart Association (NYHA) functional classification system.

  2. Glycated Hemoglobin (HbA1c)

    Time frame · Baseline, end of month 2, end of month 4, and end of month 6

    Registry description

    Measured using standard biochemical assay kit.

  3. Fasting Blood Glucose

    Time frame · Baseline, end of month 2, end of month 4, and end of month 6

    Registry description

    Venous blood sample collected after at least 8 hours of fasting; fasting glucose measured using standard enzymatic glucose oxidase laboratory kit.

  4. Body Mass Index (BMI)

    Time frame · Baseline and 6 months after intervention start

    Registry description

    Calculated as weight in kilograms divided by height in meters squared, using standardized stadiometer and scale.

  5. Quality of Life (QoL)

    Time frame · Baseline and 6 months after intervention start

    Registry description

    Assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ) score.

  6. Systolic Blood Pressure

    Time frame · Baseline, end of month 2, end of month 4, and end of month 6

    Registry description

    Measured using a calibrated automatic blood pressure device after at least 5 minutes of rest in a seated position.

  7. Serum Amylase

    Time frame · Baseline, end of month 2, end of month 4, and end of month 6

    Registry description

    Venous blood sample; serum amylase measured using standard colorimetric enzymatic laboratory kit.

  8. Alanine Aminotransferase (ALT)

    Time frame · Baseline, end of month 2, end of month 4, and end of month 6

    Registry description

    Venous blood sample; serum ALT measured using standard enzymatic spectrophotometric laboratory kit.

  9. N-terminal Pro B-type Natriuretic Peptide (NT-proBNP)

    Time frame · Baseline, end of month 2, end of month 4, and end of month 6

    Registry description

    Measured using human NT-proBNP ELISA kit.

  10. Total Cholesterol

    Time frame · Baseline, end of month 2, end of month 4, and end of month 6

    Registry description

    Venous blood sample collected after at least 8 hours of fasting; total cholesterol measured using standard colorimetric enzymatic laboratory kit.

  11. Ejection Fraction

    Time frame · Baseline, end of month 2, end of month 4, and end of month 6

    Registry description

    Assessed by echocardiography.

  12. Number of Participants With Gallbladder Problems

    Time frame · Baseline, end of month 2, end of month 4, and end of month 6

    Registry description

    Gallbladder problems (gallstones or cholecystitis) confirmed by abdominal ultrasound.

  13. Number of Participants With Hypoglycemia

    Time frame · Baseline, end of month 2, end of month 4, and end of month 6

    Registry description

    Hypoglycemia, defined as blood glucose below 70 mg/dL, measured using standard enzymatic glucose oxidase laboratory kit.

  14. Number of Participants With Injection Site Reactions

    Time frame · Baseline, end of month 2, end of month 4, and end of month 6

    Registry description

    Injection site reactions (including redness, swelling, itching, or pain at the injection site) assessed by physical examination.

  15. Number of Participants With Gastrointestinal Adverse Events

    Time frame · Baseline, end of month 2, end of month 4, and end of month 6

    Registry description

    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.

  16. Number of Participants With Pancreatitis

    Time frame · Baseline, end of month 2, end of month 4, and end of month 6

    Registry description

    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.

  17. Number of Participants With Tachycardia

    Time frame · Baseline, end of month 2, end of month 4, and end of month 6

    Registry description

    Tachycardia, defined as a resting heart rate greater than 100 beats per minute measured by pulse oximetry or ECG monitoring at scheduled study visits.

  18. Diastolic Blood Pressure

    Time frame · Baseline, end of month 2, end of month 4, and end of month 6

    Registry description

    Measured using a calibrated automatic blood pressure device after at least 5 minutes of rest in a seated position.

  19. Serum Lipase

    Time frame · Baseline, end of month 2, end of month 4, and end of month 6

    Registry description

    Venous blood sample; serum lipase measured using standard colorimetric enzymatic laboratory kit.

  20. Aspartate Aminotransferase (AST)

    Time frame · Baseline, end of month 2, end of month 4, and end of month 6

    Registry description

    Venous blood sample; serum AST measured using standard enzymatic spectrophotometric laboratory kit.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies7

Studies that cite this trial.

Studies with results

6 studies on this page

Indexing hint: Randomized controlled trial · 2025

10 results

Effects of tirzepatide on circulatory overload and end-organ damage in heart failure with preserved ejection fraction and obesity: a secondary analysis of the SUMMIT trial.

Borlaug et al. 2025Nature medicinecited by 117

PMID 39551891PMC11835708DOI 10.1038/s41591-024-03374-zPUB-39551891

CC BY10 results
Download PDFSee results (10)

Indexing hint: Randomized controlled trial · 2025

5 results

Tirzepatide for Heart Failure with Preserved Ejection Fraction and Obesity.

Packer et al. 2025The New England journal of medicinecited by 758

PMID 39555826DOI 10.1056/nejmoa2410027PUB-39555826

Full text at the publisher5 results
Publisher pageSee results (5)

Indexing hint: Randomized controlled trial · 2025

8 results

Effects of Tirzepatide on the Clinical Trajectory of Patients With Heart Failure, Preserved Ejection Fraction, and Obesity.

Zile et al. 2025Circulationcited by 58

PMID 39556714PMC11893002DOI 10.1161/circulationaha.124.072679PUB-39556714

Free to read · publisher termsCC BY-NC-ND8 results
Read at sourceSee results (8)

Indexing hint: Randomized controlled trial · 2024

4 results

Tirzepatide reduces the predicted risk of atherosclerotic cardiovascular disease and improves cardiometabolic risk factors in adults with obesity or overweight: SURMOUNT-1 post hoc analysis.

Hankosky et al. 2024Diabetes, obesity & metabolismcited by 73

PMID 37932236DOI 10.1111/dom.15318PUB-37932236

Full text at the publisher4 results
Publisher pageSee results (4)

Indexing hint: Randomized controlled trial · 2024

6 results

Semaglutide and NT-proBNP in Obesity-Related HFpEF: Insights From the STEP-HFpEF Program.

Petrie et al. 2024Journal of the American College of Cardiologycited by 84

PMID 38819334DOI 10.1016/j.jacc.2024.04.022PUB-38819334

Full text at the publisher6 results
Publisher pageSee results (6)

Indexing hint: Randomized controlled trial · 2023

6 results

Semaglutide in Patients with Heart Failure with Preserved Ejection Fraction and Obesity.

Kosiborod et al. 2023The New England journal of medicinecited by 1,372

PMID 37622681DOI 10.1056/nejmoa2306963PUB-37622681

Full text at the publisher6 results
Publisher pageSee results (6)

More studies

1 study on this page

PubMed tag: none · 2024

Effects of Semaglutide on Symptoms, Function, and Quality of Life in Patients With Heart Failure With Preserved Ejection Fraction and Obesity: A Prespecified Analysis of the STEP-HFpEF Trial.

Kosiborod et al. 2024Circulationcited by 82

PMID 37952180PMC10782938DOI 10.1161/circulationaha.123.067505PUB-37952180

Free to read · publisher termsCC BY-NC-ND
Read at source

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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