New medication for treating liver diseases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety, tolerability, and pharmacokinetics of a new medication, NNC0581-0001, in participants with hepatic steatosis and suspected steatohepatitis. Participants will receive either the medication or a placebo through monthly injections over three months. The study aims to determine how well the medication is tolerated and its effects on liver fat and inflammation. The overall duration of the study is approximately 58 weeks.

Why it matters

Who can join: the full rules

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.

Where it's running

• Parexel Research Unit
  Harrow, United Kingdom Recruiting

Study contacts

• Study coordinator: Novo Nordisk
• Email: clinicaltrials@novonordisk.com
• Phone: (+1) 866-867-7178

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.