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Can weight loss drugs boost heart function in obese heart failure patients?

NCT ID NCT06423599

Disease control Sponsor: Jens D Hove, MD,PHD Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares weight loss using semaglutide (a drug) versus a calorie-restricted diet in 100 people with obesity and heart failure with reduced ejection fraction. The goal is to see which approach better improves peak oxygen uptake, a measure of exercise capacity, after 52 weeks. Participants must be on stable heart failure medication.

What this could mean

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

Active substance
Semaglutide
What this could lead to
If successful, this could show that weight loss with semaglutide improves exercise capacity and heart function in people with obesity and heart failure.
What could go wrong
This is a mid-stage trial with only 100 participants, so results may not apply to everyone. Semaglutide can cause side effects like nausea and 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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 100 people

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

Started

Apr 2024

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: * Male or female, age ≥ 18 years at the time of signing informed consent * Body mass index (BMI) ≥ 30 kg/m2 * Heart failure with New York Heart Association (NYHA)-class 1-3 and reduced ejection fraction (EF≤40%) established by either: 1. echocardiography AND/OR 2. cardiac magnetic resonance * On stable optimal medical heart failure therapy for at least 4 weeks Exclusion Criteria: 1. Cardiovascular-related: * Any of the following: myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within the past 6 months prior to the day of screening * Planned coronary, carotid or peripheral artery revascularisation known on the day of screening * Transient heart failure related to reversible mechanisms like tachycardia, sepsis, etc. 2. Glycaemia-related: * Type 1 diabetes * Treatment with any Glucagon-Like Peptide-1 (GLP-1) agonists within 90 days prior to the day of screening * Type 2 diabetes requiring other pharmacotherapy than metformin and Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors 3. General safety: * Pregnancy or planned pregnancy * History or presence of chronic pancreatitis * Presence of acute pancreatitis within the past 180 days prior to the day of screening * Kidney disease with eGFR \< 35ml/min * Presence or history of malignant neoplasms within the past 5 years prior to the day of screening (Basal and squamous cell skin cancer and any carcinoma in-situ are allowed) * Known or suspected hypersensitivity to trial product(s) or related products

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Conditions

The condition(s) this trial relates to.

congestive heart failure heart failure Obesity obesity disorder systolic heart failure Weight Loss

As listed by the trial registrant

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

Chronic heart failure Heart failure with reduced ejection fraction Obesity Weight loss

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. 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.

Contacts and locations

Locations

  • Amager and Hvidovre Hospital University of Copenhagen

    RECRUITING

    Copenhagen, DK-2650, Denmark

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