New injection aims to tackle fatty liver
NCT ID NCT06891365
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial tests an experimental drug called NNC0581-0001 in 48 adults with fatty liver and suspected liver inflammation. Participants receive three monthly injections of either the drug or a placebo. The main goal is to check safety and how the drug moves through the body, not yet to prove it works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- NNC0581-0001 (an experimental drug injected under the skin)
- What this could lead to
- If successful, this could point toward a new treatment to reduce liver fat and inflammation in fatty liver disease.
- What could go wrong
- This is a very early Phase 1 trial with only 48 people, focused on safety. The drug may not work or could have side effects. It will take years before any treatment is available.
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
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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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About 48 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- 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
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18 to 64 years
- Sex
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Anyone
- Healthy volunteers
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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 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: * Considered eligible 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. * Male or female (of non-childbearing potential) aged 18-69 years (both inclusive) at the time of signing the informed consent. * Body mass index (BMI) greater than or equal to (\>=) 25.0 at screening. * Liver fat content measured by magnetic resonance imaging - estimated proton density fat fraction (MRI-PDFF) \>= 10 percent at screening. Additional inclusion criteria for participants in the open-label liver biopsy cohort apply: * Alanine aminotransferase (ALT) in men greater than (\>) 30 units per liter (U/L), women \> 19 U/L * Liverstiffness, measured by FibroScan® (VCTE) \> 8 kPa and less than (\<) 12 kPa * Informed consent obtained at screening for a liver biopsy to be performed at baseline and post-treatment. Note: Participants with confirmed metabolic dysfunction-associated steatohepatitis (MASH), based on a prior liver biopsy, can be included in the open-label cohort. Exclusion Criteria: * Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. * Any laboratory safety parameter, at screening, outside the extended laboratory ranges, and considered clinically significant per the principal investigator (see laboratory provided reference ranges for specific values). Of note, re-screening or re-sampling is NOT allowed if the individual has failed one of the exclusion criteria related to the following laboratory parameters: * ALT \>= 3 × upper limit of normal (ULN) * Aspartate aminotransferase (AST) \>= 3 × ULN * Bilirubin \> 1.5 × ULN * Estimated glomerular filtration rate (eGFR) \< 50 milliliter per minute per 1.73 square meters (mL/min/1.73 m\^2) at screening. Additional exclusion criteria for participants in the open-label liver biopsy group apply: * Medical history of abnormal bleeding * BMI \> 34.9 kilograms per square meters (kg/m\^2) * Presence of ascites * Cirrhosis based on screening tests or historical biopsy * Lab abnormalities of platelets count \< 150 × 10\^9 per liter or International Normalized Ratio (INR) \> 1.2 * Concomitant use of medication: * anticoagulants or herbal supplements with an anticoagulative effect (as judged by the principal investigator) * antiplatelet medications * exception for aspirin that must be stopped 5 days prior to procedure and Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) that must not be taken within 3 days of the procedure.
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Genom att skicka in godkänner du våra Användarvillkor
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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Parexel Research Unit
RECRUITINGHarrow, HA1 3UJ, United Kingdom
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