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

Sponsor
Shahid Beheshti University of Medical Sciences
Study ID
NCT07738276
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Heart Failure and Reduced Ejection Fraction
  • Obesity & Overweight
  • Tirzepatide

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tirzepatide — DRUG
    dual GLP-1/GIP receptor agonist administered subcutaneously; brief dosing summary
  • Placebo — DRUG
    Matching placebo pen containing all inactive ingredients except tirzepatide

Study Details

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

Key Dates

First listed
Jul 31, 2026
Start date
Jul 18, 2026
Status verified
Jul 2026
Primary completion
Jun 11, 2027
Completion
Dec 22, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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 Outcome Measure

Change in 6-Minute Walk Distance [ Time Frame: Baseline and 6 months after intervention start ]

Central Contacts

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