NCT06891365

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Healthy Volunteers
• Hepatic Steatosis

Interventions

Type	Name	Description
DRUG	NNC0581-0001	NNC0581-0001 will be administered subcutaneously.
DRUG	Placebo (NNC0581-0001)	Placebo matched to NNC0581-0001 will be administered subcutaneously.

Timeline

• Start date: 2025-03-12
• Primary completion: 2027-10-11
• Completion: 2027-11-15
• First posted: 2025-03-24
• Last updated: 2026-04-07

Locations

1 site across 1 country: United Kingdom