Hepatic ImpairmentPhase 1NCT05917938
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
A Phase 1 study testing NNC0194-0499 in people with Hepatic Impairment and Healthy Volunteers, run by Novo Nordisk A/S at 5 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment, Healthy Volunteers
- What is being tested?
- NNC0194-0499
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 4 Jul 2023to 16 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Poland2 sites
Uniwersyteckie Centrum Kliniczne (UCK)
Gdansk, 80-214
Cardiomedicum Sp. z o.o.
Krakow, 30-002
Slovakia2 sites
Summit Clinical Research s.r.o.
Bratislava, 83101
Summit Clinical Research s.r.o.
Malacky, 901 22
About this study
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
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.
- Conditions
- Hepatic Impairment, Healthy Volunteers
- Being tested
- NNC0194-0499
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC0194-0499Drug
NNC0194-0499 will be administered subcutaneously in a skinfold in the thigh in the form of a solution for injection.
| Study group | Role | What they receive |
|---|---|---|
| Participants With Normal Hepatic Function | Experimental | Participants with normal hepatic function will receive a single subcutaneous dose of 30 milligram (mg) of NNC0194-0499 on Day 1. Receives: Drug: NNC0194-0499 |
| Participants With Mild Hepatic Impairment | Experimental | Participants with mild hepatic impairment (Child Pugh Grade A) will receive a single subcutaneous dose of 30 mg of NNC0194-0499 on Day 1. Receives: Drug: NNC0194-0499 |
| Participants With Moderate Hepatic Impairment | Experimental | Participants with moderate hepatic impairment (Child-Pugh Grade B) will receive a single subcutaneous dose of 30 mg of NNC0194-0499 on Day 1. Receives: Drug: NNC0194-0499 |
| Participants With Severe Hepatic Impairment | Experimental | Participants with severe hepatic impairment (Child-Pugh Grade C) will receive a single subcutaneous dose of 30 mg of NNC0194-0499 on Day 1. Receives: Drug: NNC0194-0499 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From 0 hours (Day 1) until end of study visit (Day 36)
Secondary outcomes (6)
Cmax, NNC0194-0499: the maximum concentration of NNC0194-0499 in serum
Measured in nanomoles per liter (nmol/L).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From time of trial product administration (Visit 2, Day 1) until completion of the end of trial visit (Visit 8, Day 36)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start4 Jul 2023
- Primary completion16 Dec 2024
- Study completion16 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic ImpairmentStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05917938
- Sponsor's protocol ID
- NN9500-4621
- Other IDs
- 2022-001835-10, U1111-1278-1745
- Status last verified
- Feb 2026
- First submitted
- 8 Jun 2023
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05917938
- Acronym / sponsor ID
- NN9500-4621
- Conditions
- Hepatic Impairment, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 4 Jul 2023 (actual)
- Primary completion
- 16 Dec 2024 (actual)
- Study completion
- 16 Dec 2024 (actual)
- First posted
- 26 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Participants With Normal Hepatic Function | Experimental | Drug: NNC0194-0499Participants with normal hepatic function will receive a single subcutaneous dose of 30 milligram (mg) of NNC0194-0499 on Day 1. |
| Participants With Mild Hepatic Impairment | Experimental | Drug: NNC0194-0499Participants with mild hepatic impairment (Child Pugh Grade A) will receive a single subcutaneous dose of 30 mg of NNC0194-0499 on Day 1. |
| Participants With Moderate Hepatic Impairment | Experimental | Drug: NNC0194-0499Participants with moderate hepatic impairment (Child-Pugh Grade B) will receive a single subcutaneous dose of 30 mg of NNC0194-0499 on Day 1. |
| Participants With Severe Hepatic Impairment | Experimental | Drug: NNC0194-0499Participants with severe hepatic impairment (Child-Pugh Grade C) will receive a single subcutaneous dose of 30 mg of NNC0194-0499 on Day 1. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NNC0194-0499NNC0194-0499 will be administered subcutaneously in a skinfold in the thigh in the form of a solution for injection. | Drug | Participants With Mild Hepatic Impairment, Participants With Moderate Hepatic Impairment, Participants With Normal Hepatic Function, Participants With Severe Hepatic Impairment |
Primary outcome
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).
6 secondary outcomes
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)
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NNC0194-0499 in people with Hepatic Impairment and Healthy Volunteers, run by Novo Nordisk A/S at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Poland, Slovakia, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: From 0 hours (Day 1) until end of study visit (Day 36)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.