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

What Was Tested

This registered phase 3 trial tested Tirzepatide.

It will also learn about the safety of tirzepatide.

It had two arms (groups): Tirzepatide (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

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.

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.

Who Took Part

Enrollment: 60 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age 18 years or older. 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.

The full record lists 5 inclusion and 9 exclusion criteria; among the exclusions: acute heart failure decompensation or cardiac hospitalization within the prior 4 weeks; uncontrolled blood pressure (systolic blood pressure \<90 mmhg or ≥180 mmhg); severe hepatic impairment (liver enzymes elevated to 3 times the upper limit of normal).

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

Because people in this Tirzepatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Tirzepatide group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Tirzepatide.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2026-07-18 with completion listed for 2027-06-11.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in 6-Minute Walk Distance (time frame: Baseline and 6 months after intervention start).

It also tracked 25 secondary outcomes, for example NYHA Functional Class, Glycated Hemoglobin (HbA1c), Fasting Blood Glucose, Body Mass Index (BMI), Quality of Life (QoL) and Systolic Blood Pressure.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Tirzepatide in 60 people.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Tirzepatide compound page, all human trials.