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Multiple Dose Study for a New Medication to Potentially Treat Liver Diseases
Sponsor: Novo Nordisk A/S
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.
Official title: Investigation of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of NNC0581-0001 in Participants With Hepatic Steatosis and Suspected Steatohepatitis
Key Details
Gender
All
Age Range
18 Years - 64 Years
Study Type
INTERVENTIONAL
Enrollment
48
Start Date
2025-03-12
Completion Date
2027-11-15
Last Updated
2026-04-07
Healthy Volunteers
No
Conditions
Interventions
NNC0581-0001
NNC0581-0001 will be administered subcutaneously.
Placebo (NNC0581-0001)
Placebo matched to NNC0581-0001 will be administered subcutaneously.
Locations (1)
Parexel Research Unit
Harrow, United Kingdom