Clinical trial 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
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatic Impairment
Healthy Volunteers
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2023-06-26
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: AUC0-∞, Single Dose, NNC0194-0499: the area under the NNC0194-0499 serum concentration-time curve from time 0 to infinity after a single dose
timeFrame: From 0 hours (Day 1) until end of study visit (Day 36)
Secondary outcomes:
measure: Cmax, NNC0194-0499: the maximum concentration of NNC0194-0499 in serum
timeFrame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
measure: tmax, NNC0194-0499: the time from dose administration to maximum serum concentration of NNC0194-0499
timeFrame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
measure: t1/2, NNC0194-0499: the terminal half-life of NNC0194-0499 in serum
timeFrame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
measure: CL/F, NNC0194-0499: the apparent total serum clearance of NNC0194-0499
timeFrame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
measure: Vz/F, NNC0194-0499: apparent volume of distribution of NNC0194-0499 after a single dose
timeFrame: From Day 1 (pre-dose) until completion of the end of trial visit (Day 36)
measure: Number of treatment emergent adverse events (TEAEs)
timeFrame: From time of trial product administration (Visit 2, Day 1) until completion of the end of trial visit (Visit 8, Day 36)
Other outcomes:
Locations:
city: München
country: Germany
facility: APEX Research
city: Gdańsk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne (UCK)
city: Bratislava
country: Slovakia
facility: Summit Clinical Research s.r.o.
city: Malacky
country: Slovakia
facility: Summit Clinical Research s.r.o.
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: