Multiple Dose Study for a New Medication to Potentially Treat Liver Diseases

Launched by NOVO NORDISK A/S · Mar 17, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called NNC0581-0001, which may help treat liver diseases, particularly conditions where there is extra fat in the liver. The goal is to see how safe the medication is and how well the body handles it. Participants in the study will receive either the new medication or a placebo (a dummy treatment) through an injection under the skin once a month for three months. The trial will take about 58 weeks to complete and is currently looking for healthy volunteers who are between 18 and 64 years old and have specific liver health indicators.

To be eligible for the trial, participants should have a body mass index (BMI) between 25 and 39.9 and show signs of increased liver fat and stiffness. Those interested in joining will undergo health screenings, including medical history checks and tests to ensure their safety. It's important to note that this medication is not available for prescription yet, as it is still being studied. Participants can expect regular visits for monitoring and tests throughout the trial.

Gender

ALL

Eligibility criteria

• 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 18-64 years (both inclusive) at the time of signing the informed consent.
• • Body mass index (BMI) 25.0 to 39.9 kilogram per square meter (kg/m\^2) (both inclusive) at screening.
• • Liver fat content measured by magnetic resonance imaging - estimated proton density fat fraction (MRI-PDFF) greater than or equal to (\>=) 10 percent and liver stiffness greater than 8 kilopascal (kPa) as measured by FibroScan® (vibration-controlled transient elastography \[VCTE™\]).
• 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) \< 60 milliliter per minute per 1.73 square meters (mL/min/1.73 m\^2) at screening.