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NCT Number: 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

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.

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Key information

Conditions

Hepatic Impairment Healthy Volunteers

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

APEX Research, München, Germany

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NNC0194-0499

Drug

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

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

    Time frame: From 0 hours (Day 1) until end of study visit (Day 36)

    Measured in nanomoles hour per liter (nmol h/L).

Secondary outcomes

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

    Time frame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)

    Measured in nanomoles per liter (nmol/L).

  2. tmax, NNC0194-0499: the time from dose administration to maximum serum concentration of NNC0194-0499

    Time frame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)

    Measured in hours.

  3. t1/2, NNC0194-0499: the terminal half-life of NNC0194-0499 in serum

    Time frame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)

    Measured in hours.

  4. CL/F, NNC0194-0499: the apparent total serum clearance of NNC0194-0499

    Time frame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)

    Measured in liters per hour.

  5. Vz/F, NNC0194-0499: apparent volume of distribution of NNC0194-0499 after a single dose

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

    Measured in liters.

  6. Number of treatment emergent adverse events (TEAEs)

    Time frame: From time of trial product administration (Visit 2, Day 1) until completion of the end of trial visit (Visit 8, Day 36)

    Measured as number of events.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 26, 2023
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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