NCT05599945

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

A First Human Dose Study Investigating Safety, Tolerability, and Pharmacokinetics of Single Subcutaneous Injections of NNC0581-0001 in Healthy Adults and in Participants With Hepatic Steatosis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers
• Hepatic Steatosis

Interventions

Type	Name	Description
DRUG	NNC0581-0001	Participants will receive up to six single dose levels of subcutaneous NNC0581-0001 in a sequential manner with the dose increasing between cohorts.
DRUG	Placebo (NNC0581-0001)	Participants will receive single dose of subcutaneous injection of placebo matched to NNC0581-0001.

Timeline

• Start date: 2022-11-23
• Primary completion: 2025-08-29
• Completion: 2025-08-29
• First posted: 2022-10-31
• Last updated: 2025-10-09

Locations

2 sites across 1 country: United Kingdom