NCT05917938

A Research Study Looking at How a Single Dose of the Study Medicine NNC0194-0499 Behaves in Participants With Reduced Liver Function Compared to Participants With Normal Liver Function

Investigation of Pharmacokinetics, Safety and Tolerability of a Single Subcutaneous Dose of NNC0194-0499 in Participants With Various Degrees of Hepatic Impairment and Normal Hepatic Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The study medicine NNC0194-0499 is under development for non-alcoholic fatty liver disease (NAFLD) including non-alcoholic steatohepatitis (NASH). All participants will receive a single dose of 30 milligram (mg) of the study medicine. The study medicine will be given in the form of an injection of 0.6 millilitres in a skinfold of the thigh (subcutaneous). The study will last for up to 64 days. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period. Women who are able to become pregnant must use highly effective contraception and will be counselled on the use of contraception. Participants with impaired liver function will undergo an ultrasound of the belly and measurement of brain activity.

Conditions

• Hepatic Impairment
• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	NNC0194-0499	NNC0194-0499 will be administered subcutaneously in a skinfold in the thigh in the form of a solution for injection.

Timeline

• Start date: 2023-07-04
• Primary completion: 2024-12-16
• Completion: 2024-12-16
• First posted: 2023-06-26
• Last updated: 2026-02-11

Locations

5 sites across 3 countries: Germany, Poland, Slovakia