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

Status and phase: Completed; Phase 1

Conditions: Hepatic Impairment; Healthy Volunteers

Treatments: Drug: NNC0194-0499

Study type: Interventional

Funder types: Industry

Identifiers

NCT05917938

U1111-1278-1745 (Other Identifier)

2022-001835-10 (EudraCT Number)

NN9500-4621

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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33 participants in 4 patient groups

Participants With Normal Hepatic Function

Experimental group

Description:

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

Treatment:

Drug: NNC0194-0499

Participants With Mild Hepatic Impairment

Experimental group

Description:

Participants with mild hepatic impairment (Child Pugh Grade A) will receive a single subcutaneous dose of 30 mg of NNC0194-0499 on Day 1.

Treatment:

Drug: NNC0194-0499

Participants With Moderate Hepatic Impairment

Experimental group

Description:

Participants with moderate hepatic impairment (Child-Pugh Grade B) will receive a single subcutaneous dose of 30 mg of NNC0194-0499 on Day 1.

Treatment:

Drug: NNC0194-0499

Participants With Severe Hepatic Impairment

Experimental group

Description:

Participants with severe hepatic impairment (Child-Pugh Grade C) will receive a single subcutaneous dose of 30 mg of NNC0194-0499 on Day 1.

Treatment:

Drug: NNC0194-0499