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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers; Hepatic Impairment
• Intervention / Treatment: Drug: NNC0194-0499

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • München, Germany, 81241
    • Apex Research
• Poland
  • Gdansk, Poland, 80-214
    • Uniwersyteckie Centrum Kliniczne (UCK)
  • Krakow, Poland, 30-002
    • Cardiomedicum Sp. z o.o.
• Slovakia
  • Bratislava, Slovakia, 83101
    • Summit Clinical Research s.r.o.
  • Malacky, Slovakia, 901 22
    • Summit Clinical Research s.r.o.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Male or female.
• Aged 18-80 years (both inclusive) at the time of signing informed consent.
• Body mass index (BMI) between 18.5-39.9 kilogram per square meter (kg/m^2) (both inclusive). Specific inclusion criterion only for participants with hepatic impairment:
• Participants with stable hepatic impairment classified as Child-Pugh grade A, B or C as assessed by the investigator. Stable hepatic impairment is defined as no clinically significant change in disease status, as judged by the investigator.

Exclusion Criteria:

• Known or suspected hypersensitivity to study intervention(s) or related products.
• Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Participants With Normal Hepatic Function; Participants with normal hepatic function will receive a single subcutaneous dose of 30 milligram (mg) of NNC0194-0499 on Day 1.	Drug: NNC0194-0499; NNC0194-0499 will be administered subcutaneously in a skinfold in the thigh in the form of a solution for injection.
Experimental: Participants With Mild Hepatic Impairment; Participants with mild hepatic impairment (Child Pugh Grade A) will receive a single subcutaneous dose of 30 mg of NNC0194-0499 on Day 1.	Drug: NNC0194-0499; NNC0194-0499 will be administered subcutaneously in a skinfold in the thigh in the form of a solution for injection.
Experimental: Participants With Moderate Hepatic Impairment; Participants with moderate hepatic impairment (Child-Pugh Grade B) will receive a single subcutaneous dose of 30 mg of NNC0194-0499 on Day 1.	Drug: NNC0194-0499; NNC0194-0499 will be administered subcutaneously in a skinfold in the thigh in the form of a solution for injection.
Experimental: Participants With Severe Hepatic Impairment; Participants with severe hepatic impairment (Child-Pugh Grade C) will receive a single subcutaneous dose of 30 mg of NNC0194-0499 on Day 1.	Drug: NNC0194-0499; NNC0194-0499 will be administered subcutaneously in a skinfold in the thigh in the form of a solution for injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC0-∞, Single Dose, NNC0194-0499: the area under the NNC0194-0499 serum concentration-time curve from time 0 to infinity after a single dose	Measured in nanomoles hour per liter (nmol h/L).	From 0 hours (Day 1) until end of study visit (Day 36)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax, NNC0194-0499: the maximum concentration of NNC0194-0499 in serum	Measured in nanomoles per liter (nmol/L).	From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
tmax, NNC0194-0499: the time from dose administration to maximum serum concentration of NNC0194-0499	Measured in hours.	From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
t1/2, NNC0194-0499: the terminal half-life of NNC0194-0499 in serum	Measured in hours.	From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
CL/F, NNC0194-0499: the apparent total serum clearance of NNC0194-0499	Measured in liters per hour.	From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Vz/F, NNC0194-0499: apparent volume of distribution of NNC0194-0499 after a single dose	Measured in liters.	From Day 1 (pre-dose) until completion of the end of trial visit (Day 36)
Number of treatment emergent adverse events (TEAEs)	Measured as number of events.	From time of trial product administration (Visit 2, Day 1) until completion of the end of trial visit (Visit 8, Day 36)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2023
• Primary Completion (Actual): December 16, 2024
• Study Completion (Actual): December 16, 2024

Study Registration Dates

• First Submitted: June 8, 2023
• First Submitted That Met QC Criteria: June 23, 2023
• First Posted (Actual): June 26, 2023

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: NN9500-4621; 2022-001835-10 (EudraCT Number); U1111-1278-1745 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No