New fatty liver drug tested in humans for first time
NCT ID NCT05599945
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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48 people
The number who actually took part.
- Started
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Nov 2022
- Finished
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Aug 2025
- Lead sponsor
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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
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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
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Parexel CPRU, Level 7
Harrow, Middlesex, HA1 3UJ, United Kingdom
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Parexel Research Unit
Harrow, Middlesex, HA1 3UJ, United Kingdom
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