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New NAFLD drug safety checked in patients with liver damage

NCT ID NCT05917938

Knowledge-focused 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a single injection of a new drug (NNC0194-0499) for non-alcoholic fatty liver disease in 33 people with various degrees of liver impairment and healthy volunteers. The goal was to see how the liver processes the drug and whether it is safe. Results will help determine the right dose for future studies in patients with liver problems.

What this could mean

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

Active substance
NNC0194-0499
What this could lead to
If successful, this study will help doctors decide the right dose of this NAFLD drug for patients with liver problems, making future treatments safer.
What could go wrong
This is a very early, small study (33 people) focused on safety and drug levels, not on whether the drug works. Results may not apply to all patients.

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

33 people

The number who actually took part.

Started

Jul 2023

Finished

Dec 2024

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

18 to 80 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 female. * Aged 18-80 years (both inclusive) at the time of signing informed consent. * Body mass index (BMI) between 18.5-39.9 kilogram per square meter (kg/m\^2) (both inclusive). Specific inclusion criterion only for participants with hepatic impairment: * Participants with stable hepatic impairment classified as Child-Pugh grade A, B or C as assessed by the investigator. Stable hepatic impairment is defined as no clinically significant change in disease status, as judged by the investigator. Exclusion Criteria: * Known or suspected hypersensitivity to study intervention(s) or related products. * Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method.

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Conditions

The condition(s) this trial relates to.

liver disorder

As listed by the trial registrant

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

Healthy volunteers Hepatic impairment

Contacts and locations

Locations

  • APEX Research

    München, 81241, Germany

  • Cardiomedicum Sp. z o.o.

    Krakow, 30-002, Poland

  • Summit Clinical Research s.r.o.

    Bratislava, 83101, Slovakia

  • Summit Clinical Research s.r.o.

    Malacky, 901 22, Slovakia

  • Uniwersyteckie Centrum Kliniczne (UCK)

    Gdansk, 80-214, Poland

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