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

Novo Nordisk A/S33 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatic Impairment Healthy Volunteers

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (5)

APEX Research

München, Germany

Uniwersyteckie Centrum Kliniczne (UCK)

Gdansk, Poland

Cardiomedicum Sp. z o.o.

Krakow, Poland

Summit Clinical Research s.r.o.

Bratislava, Slovakia

Summit Clinical Research s.r.o.

Malacky, Slovakia

Outcomes

Primary Outcomes

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).

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

Secondary Outcomes

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

Measured in nanomoles per liter (nmol/L).

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

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