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RECRUITING
NCT06891365
PHASE1

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

Sponsor: Novo Nordisk A/S

View on ClinicalTrials.gov

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

Interventions

DRUG

NNC0581-0001

NNC0581-0001 will be administered subcutaneously.

DRUG

Placebo (NNC0581-0001)

Placebo matched to NNC0581-0001 will be administered subcutaneously.

Locations (1)

Parexel Research Unit

Harrow, United Kingdom