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Can a diabetes drug help heart failure patients walk farther?

NCT ID NCT07738276

Disease control Sponsor: Shahid Beheshti University of Medical Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 31, 2026 · Last updated Aug 04, 2026 · Updated 2 times

Summary

This trial tests whether tirzepatide, a weekly injection used for diabetes and weight loss, can improve physical function in adults with heart failure and obesity. Participants will receive either tirzepatide or a placebo for six months, while continuing their usual heart failure medications. The main goal is to see if tirzepatide increases how far they can walk in six minutes, and also to check its effects on symptoms, quality of life, and safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tirzepatide, a dual GLP-1/GIP receptor agonist given as a weekly injection
What this could lead to
If tirzepatide improves physical function and quality of life in people with heart failure and obesity, it could become a new treatment option for this high-risk group.
What could go wrong
This is a relatively small trial, and results may not apply to all patients. Tirzepatide can cause side effects like nausea and digestive issues, and it may not improve walking distance as hoped.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

heart failure Obesity obesity disorder Overweight systolic heart failure Weight Loss

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heart failure and reduced ejection fraction Obesity & overweight Tirzepatide

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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More trials for these conditions

Other studies related to the condition(s) this trial covers.