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New fatty liver drug tested in humans for first time

NCT ID NCT05599945

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early-stage study tested a new medicine called NNC0581-0001 in 48 adults, including healthy volunteers and people with fatty liver (hepatic steatosis). The main goal was to check safety and how the drug moves through the body after a single injection under the skin. Participants were randomly assigned to receive either the drug or a placebo. The study lasted about 58 weeks and was completed.

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

48 people

The number who actually took part.

Started

Nov 2022

Finished

Aug 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

18 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, for healthy participants in Part A: * Female of non-childbearing potential or male aged 18-55 years (both inclusive) at the time of signing informed consent. * Body Mass Index (BMI) from 18.5 to 30.0 kilogram per square meter (kg/m\^2) (both inclusive) at screening. * Considered to be 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. Inclusion criteria for participants with hepatic steatosis in Part B: * Female of non-childbearing potential or male aged 18-55 years (both inclusive) at the time of signing informed consent. * Body Mass Index (BMI) from 25.0 to 34.9 kilogram per square meter (kg/m\^2) (both inclusive) at screening. * Hepatic steatosis identified by a score above 248 dB/m by Fibroscan® (Controlled Attenuated Parameter, CAP) at screening. Exclusion Criteria * Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. * For Part A: Any laboratory safety parameters at screening outside the below laboratory ranges, see laboratory provided reference ranges for specific values (re-screening or re-sampling is NOT allowed if the participant has failed one of the exclusion criteria related to laboratory parameters): * Alanine aminotransferase (ALT) greater than upper normal limit (UNL) plus 10 percent * Aspartate aminotransferase (AST) greater than UNL plus 10 percent * Bilirubin greater than UNL plus 10 percent * Estimated glomerular filtration rate (eGFR) below 90 milliliters per minute per 1.73 square meters (90 mL/min/1.73m\^2) * Glycated haemoglobin (HbA1c) greater than or equal to 5.7 percent (39 millimole per mole \[mmol/mol\]) at screening.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Parexel CPRU, Level 7

    Harrow, Middlesex, HA1 3UJ, United Kingdom

  • Parexel Research Unit

    Harrow, Middlesex, HA1 3UJ, United Kingdom

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