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First human test of novel heart failure drug begins

NCT ID NCT06625307

Disease control Sponsor: Novo Nordisk A/S 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new medicine called NNC0537-1482, designed to potentially treat heart failure. It is the first time this drug is given to humans, so healthy volunteers receive a single injection under the skin to check for safety and how the body processes it. Participants are randomly assigned to receive either the drug or a placebo. The results will help decide if further testing in heart failure patients is warranted.

What this could mean

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

Active substance
NNC0537-1482
What this could lead to
If safe and effective, this could lead to a new treatment option for people with heart failure.
What could go wrong
This is an early Phase 1 trial in healthy volunteers, so it may not work in heart failure patients or may have unexpected side effects.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

31 people

The number who actually took part.

Started

Oct 2024

Finished

May 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

22 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 postmenopausal female. * Age 22-55 years (both inclusive) at the time of signing the informed consent. * Body Mass Index (BMI) between 18.5 and 30.0 kilogram/meter per square (kg/m\^2) (both inclusive) at screening. * Considered eligible and generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator. Exclusion Criteria: * Known or suspected hypersensitivity to study intervention(s) or related products. * Use of prescription or non-prescription medicinal products, including herbal medications, within 14 days before screening. Occasional use of over-the-counter vitamins, or paracetamol or Non-steroidal anti-inflammatory drugs (NSAIDs) at their labelled doses for mild pain is permitted. * Any condition which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. * Orthostatic hypotension, defined as a decrease in systolic blood pressure greater than or equal to 20 millimetres of mercury (mmHg) or a decrease in diastolic blood pressure greater than or equal to 10 (mmHg) from supine to standing after 3 minutes, at the screening visit. * Any laboratory safety parameters at screening outside the below laboratory ranges for: * Alanine Aminotransferase (ALT) greater than (\>) Upper normal limits (UNL) plus (+) 10 Percentage (%) * Aspartate Aminotransferase (AST) \> Upper limit normal (ULN) +20% * Bilirubin \> ULN + 20% * Creatinine \> ULN + 10%

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Conditions

The condition(s) this trial relates to.

heart failure

As listed by the trial registrant

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

Healthy volunteers Heart failure

Contacts and locations

Locations

  • ICON - location Groningen

    Groningen, 9728 NZ, Netherlands

More trials for these conditions

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