Clinical trial

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

Name

NN9500-4621

Description

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.

Trial arms

Trial start

2023-07-05

Estimated PCD

2024-08-17

Trial end

2024-08-17

Status

Recruiting

Phase

Early phase I

Treatment

NNC0194-0499

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

Arms:

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

Size

Primary endpoint

AUC0-∞, Single Dose, NNC0194-0499: the area under the NNC0194-0499 serum concentration-time curve from time 0 to infinity after a single dose

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

Eligibility criteria

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 35, 'type': 'ESTIMATED'}}

Updated at

2024-04-02

1 organization

1 product

2 indications

Organization

Novo Nordisk

Product

NNC0194-0499

Indication

Liver Impairment

Indication

Healthy Control Participants