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

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.

NCT Number	NCT06891365
Lead Sponsor	Novo Nordisk A/S
Conditions	Healthy Volunteers, Hepatic Steatosis
Enrollment	48 participants
Start Date	2025-03-12
Primary Completion	2027-10-11 (estimated)
Study Completion	2027-11-15 (estimated)
Updated on ClinicalTrials.gov	2026-04-07