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Could a diabetes drug help heart defect patients lose weight?

NCT ID NCT07354880

Disease control Sponsor: University Medical Centre Ljubljana 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests the drug tirzepatide (Munjaro) in 30 obese adults with congenital heart disease. Over 6 months, half get the drug and half get a placebo. Researchers will check if it improves exercise ability, heart function, and cholesterol. It is one of the first studies to look at modern weight-loss drugs in this specific group.

What this could mean

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

Active substance
tirzepatide (Munjaro)
What this could lead to
If it works, this could point toward a safe way to help people with congenital heart disease lose weight and improve heart health.
What could go wrong
This is a small, early-phase trial with only 30 people, so results may not apply to everyone. The drug may cause side effects like nausea or vomiting.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 30 people

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

Expected to start

Jan 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 to 70 years

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: * Obese or overweight adult patients with congenital heart disease * BMI between 30 kg/m² and 40 kg/m² * Prior comprehensive non-pharmacological and non-surgical management of obesity, including a history of at least 12 months of intensive lifestyle intervention with a maximum weight reduction of less than 5% * Stable body weight within the three months preceding study enrollment (defined as weight fluctuations within 5%) * No prior pharmacological or surgical interventions for obesity * Euthyroid state * Eumenorrhea or oligomenorrhea * Ability to comprehend the study objectives and procedures * Willingness to provide informed consent and to comply with the study protocol, including the use of highly effective contraception during the study period, with signed consent and agreement provided in duplicate * Commitment to use highly reliable contraception and absence of plans for pregnancy within the 8 months following enrollment. Exclusion Criteria: * Down syndrome * Type 2 diabetes * Severe heart failure (NYHA IV), EF of systemic or subpulmonary ventricle \< 30%, malignant arrhythmias, severe heart valve disease * Personal history of malignancy, personal or family history of medullary thyroid carcinoma * Personal history of pancreatitis or cholelithiasis * Personal history of acute coronary events or hemodynamically significant coronary artery disease * Current treatment with sympathomimetics or sympatholytic * Psychiatric disorders, personal history of depressive disorders or suicidal ideation * Pregnancy or lactation, postmenopausal, amenorrhea, reliance on natural contraception methods * Excessive alcohol consumption * Smoking

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Conditions

The condition(s) this trial relates to.

congenital heart disease Obesity obesity disorder Overweight

As listed by the trial registrant

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

Adult congenital heart disease Obesity & overweight

How to take part

Only the study team decides who joins. These are the ways to reach them.

  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

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

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