drugset
drugset / Trial / 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

NCT05917938 ↗

Phase 1 Completed 33 enrolled Novo Nordisk A/S
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2023-07-04
Primary completion
2024-12-16
Completion
2024-12-16

Drugs

EvaluationDrugModalityDoseRoute
Subject zalfermin Protein / enzyme biologic 30 mg Subcutaneous

Indications

No indication recorded.