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 | Completed Phase 1

• 3 other identifiers: NN9500-46212022-001835-10U1111-1278-1745
• Study Type: interventional
• Target: 33
• Locations: 3 countries
• Sites: 5

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Cmax, NNC0194-0499: the maximum concentration of NNC0194-0499 in serum

  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

  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

  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

  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

  From Day 1 (pre-dose) until completion of the end of trial visit (Day 36)

Study Arms (4)

Participants With Normal Hepatic Function

EXPERIMENTAL

Participants with normal hepatic function will receive a single subcutaneous dose of 30 milligram (mg) of NNC0194-0499 on Day 1.

Drug: NNC0194-0499

Participants With Mild Hepatic Impairment

EXPERIMENTAL

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

Participants With Moderate Hepatic Impairment

EXPERIMENTAL

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

Participants With Severe Hepatic Impairment

EXPERIMENTAL

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

Interventions

NNC0194-0499 DRUG

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

Participants With Mild Hepatic Impairment; Participants With Moderate Hepatic Impairment; Participants With Normal Hepatic Function; Participants With Severe Hepatic Impairment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female.
• Aged 18-80 years (both inclusive) at the time of signing informed consent.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (5)

APEX Research

München, 81241, Germany

Location

Uniwersyteckie Centrum Kliniczne (UCK)

Gdansk, 80-214, Poland

Location

Cardiomedicum Sp. z o.o.

Krakow, 30-002, Poland

Location

Summit Clinical Research s.r.o.

Bratislava, 83101, Slovakia

Location

Summit Clinical Research s.r.o.

Malacky, 901 22, Slovakia

Location

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2023
• First Posted: June 26, 2023
• Study Start: July 4, 2023
• Primary Completion: December 16, 2024
• Study Completion: December 16, 2024
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

DE (1); PL (2); SL (2)