Multiple Dose Study for a New Medication to Potentially Treat Liver Diseases
Investigation of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of NNC0581-0001 in Participants With Hepatic Steatosis and Suspected Steatohepatitis
Novo Nordisk A/S
48 participants
Mar 12, 2025
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of NNC0581-0001 in participants with hepatic steatosis and suspected steatohepatitis (increased liver fat and suspected inflammation). NNC0581-0001 will be given in 2 different dose levels as injection under the skin (once per month for 3 months). Participants will either get NNC0581-001 or Placebo (dummy treatment). Which treatment participants get is decided by chance. NNC0581-0001 is a new medicine which cannot be prescribed by doctors. The study will last about 58 weeks.
Eligibility
Inclusion Criteria8
- 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.
- 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 Criteria14
- Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- 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.
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
NNC0581-0001 will be administered subcutaneously.
Placebo matched to NNC0581-0001 will be administered subcutaneously.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06891365