drugset
drugset / Trial / NCT05599945

First Human Dose Trial for a New Medication to Potentially Treat Liver Diseases

NCT05599945 ↗

Phase 1 Completed 48 enrolled Novo Nordisk A/S
RandomizedSequentialQuadruple-blindTreatment

Summary

This study will assess the safety, tolerability, the pharmacokinetics from single injection (under the skin) of NNC0581-0001 and explores the pharmacodynamics in healthy participants and participants with hepatic steatosis (increased liver fat). 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.

Timeline

Start
2022-11-23
Primary completion
2025-08-29
Completion
2025-08-29

Drugs

EvaluationDrugModalityDoseRoute
Subject NNC0581-0001 Unknown 10 mg Subcutaneous
Subject NNC0581-0001 Unknown 30 mg Subcutaneous
Subject NNC0581-0001 Unknown 90 mg Subcutaneous
Subject NNC0581-0001 Unknown 250 mg Subcutaneous
Subject NNC0581-0001 Unknown 600 mg Subcutaneous
Subject NNC0581-0001 Unknown 1000 mg Subcutaneous

Indications

fatty liver disease