Non-alcoholic SteatohepatitisPhase 1NCT04722653
A Research Study Looking at How the Medicine NNC0194-0499 Behaves in Japanese and Non-Asian Men
A Phase 1 study testing NNC0194-0499 in people with Non-alcoholic Steatohepatitis, run by Novo Nordisk A/S at 1 site in Japan.
Trial summary
This study looks at how a new medicine called NNC0194-0499 works in the body of Japanese men and non-Asian men. Japanese participants will either get NNC0194-0499 or placebo - which treatment participants get is decided by chance. Non-Asian participants will get NNC0194-0499. Read more about this study
- Who is it for?
- Ages 20 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Non-alcoholic Steatohepatitis
- What is being tested?
- NNC0194-0499
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteJapan
- Study dates
- 2 Feb 2021to 27 Apr 2021
- 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 20 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male, aged 20-55 years (both inclusive) at the time of signing informed consent
- For Japanese subjects only, both parents of Japanese descent. For non-Asian subjects only, both parents of non-Asian descent
- Body mass index (BMI) between 23.0 and 34.9 kg/m^2 (both inclusive)
- Body weight greater than or equal to 60 kg
Who cannot join
- Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
- Subjects aged above or equal to 40 years with an estimated 10-year atherosclerotic cardiovascular disease risk (as described in the American College of Cardiology and the American Heart Association Prevention Guideline) greater than or equal to 5 percentage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Safety, Tolerability and Pharmacokinetic Properties of Single Subcutaneous Doses of NNC0194-0499 in Japanese and Non-Asian Male Subjects
This study looks at how a new medicine called NNC0194-0499 works in the body of Japanese men and non-Asian men.
Japanese participants will either get NNC0194-0499 or placebo - which treatment participants get is decided by chance. Non-Asian participants will get NNC0194-0499.
Read more
Participants will get 1 or 2 injections of the study medicine. It will be injected with a needle into a skin fold on the stomach.
The study will last for a maximum of 66 days. Participants will have 8 scheduled visits with the study doctor. For 1 of the visits participants will stay at the clinic for 6 days (5 nights).
The study includes blood sampling. Participants will not be able to take part in the study if the study doctor thinks there is a risk for participants health.
- Conditions
- Non-alcoholic Steatohepatitis
- Being tested
- NNC0194-0499, Placebo (NNC0194-0499 )
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC0194-0499Drug
1 single dose administered subcutaneously (s.c. - under the skin)
Placebo (NNC0194-0499 )Drug
1 single dose administered subcutaneously (s.c. - under the skin).
| Study group | Role | What they receive |
|---|---|---|
| NN0194-0499 | Experimental | Japanese participants will be randomised 3:1 to receive either a single dose of NNC0194-0499 or placebo, Asian participants will only receive NNC0194-0499. There will be 3 cohorts with escalating dose levels. There should be at least 4 days between dose administration of the last participant in a dose level cohort and dose administration of the first participant in the following dose level cohort. Receives: Drug: NNC0194-0499 |
| Placebo | Placebo comparator | Japanese participants will be randomised 3:1 to receive either a single dose of NNC0194-0499 or placebo. Receives: Drug: Placebo (NNC0194-0499 ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment emergent adverse events (TEAEs)
Count of events
Measured: From Day 1 (pre-dose) until completion of the post-treatment period at follow-up (Day 36)
Secondary outcomes (9)
AUC0-∞, SD: The area under the NNC0194-0499 serum concentration-time curve from time 0 to infinity after a single s.c.(subcutaneous) administration
h·nmol/L
Measured: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
AUC0-tz, SD: The area under the NNC0194-0499 serum concentration-time curve from time 0 to the time of the last quantifiable sample after a single s.c. administration
h·nmol/L
Measured: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
AUC0-168h, SD: The area under the NNC0194-0499 serum concentration-time curve from time 0 to 168 hours after a single s.c. administration
h·nmol/L
Measured: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Cmax, SD: Maximum concentration of NNC0194-0499 in serum after a single s.c. administration
nmol/L
Measured: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
tmax, SD: Time from dose administration to maximum serum concentration of NNC0194-0499 after a single s.c. administration
Hours
Measured: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
t½, SD: Terminal half-life of NNC0194-0499
Hours
Measured: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
CL/FSD: Apparent total serum clearance of NNC0194-0499
L/h
Measured: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Vz/FSD: Apparent volume of distribution of NNC0194-0499 in the terminal phase
L
Measured: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
MRTSD: The mean residence time of NNC0194-0499 after a single s.c. administration
Hours
Measured: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start2 Feb 2021
- Primary completion27 Apr 2021
- Study completion27 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-alcoholic SteatohepatitisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The present trial is split into two parts reflecting the two trial populations: Japanese subjects and non-Asian subjects. For the Japanese part, it is designed as a randomised, placebo-controlled, double-blinded within cohorts, parallel group, single-dose trial. The non-Asian part is run in parallel to the Japanese part in an open design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04722653
- Sponsor's protocol ID
- NN9500-4663
- Other IDs
- U1111-1255-1392
- Status last verified
- Apr 2022
- First submitted
- 21 Jan 2021
- Last updated
- 5 Apr 2022
- 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
Publications
Dahl K, Friedrichsen MH, Ribel-Madsen R, Hansen JS, Clausen JO, Axelsen M, Palle MS, Lippert SL, Bjorkdahl O, Toubro S, Key C, Andersen B. Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Novel Long-Acting FGF21 Analog Zalfermin. Clin Transl Sci. 2025 Dec;18(12):e70435. doi: 10.1111/cts.70435.
PubMed 41351276
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Safety, Tolerability and Pharmacokinetic Properties of Single Subcutaneous Doses of NNC0194-0499 in Japanese and Non-Asian Male Subjects
- ClinicalTrials.gov ID
- NCT04722653
- Acronym / sponsor ID
- NN9500-4663
- Conditions
- Non-alcoholic Steatohepatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 2 Feb 2021 (actual)
- Primary completion
- 27 Apr 2021 (actual)
- Study completion
- 27 Apr 2021 (actual)
- First posted
- 25 Jan 2021 (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.
This study looks at how a new medicine called NNC0194-0499 works in the body of Japanese men and non-Asian men.
Japanese participants will either get NNC0194-0499 or placebo - which treatment participants get is decided by chance. Non-Asian participants will get NNC0194-0499.
Participants will get 1 or 2 injections of the study medicine. It will be injected with a needle into a skin fold on the stomach.
The study will last for a maximum of 66 days. Participants will have 8 scheduled visits with the study doctor. For 1 of the visits participants will stay at the clinic for 6 days (5 nights).
The study includes blood sampling. Participants will not be able to take part in the study if the study doctor thinks there is a risk for participants health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The present trial is split into two parts reflecting the two trial populations: Japanese subjects and non-Asian subjects. For the Japanese part, it is designed as a randomised, placebo-controlled, double-blinded within cohorts, parallel group, single-dose trial. The non-Asian part is run in parallel to the Japanese part in an open design
| Arm | Type | Receives |
|---|---|---|
| NN0194-0499 | Experimental | Drug: NNC0194-0499Japanese participants will be randomised 3:1 to receive either a single dose of NNC0194-0499 or placebo, Asian participants will only receive NNC0194-0499. There will be 3 cohorts with escalating dose levels. There should be at least 4 days between dose administration of the last participant in a dose level cohort and dose administration of the first participant in the following dose level cohort. |
| Placebo | Placebo comparator | Drug: Placebo (NNC0194-0499 )Japanese participants will be randomised 3:1 to receive either a single dose of NNC0194-0499 or placebo. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male, aged 20-55 years (both inclusive) at the time of signing informed consent
- For Japanese subjects only, both parents of Japanese descent. For non-Asian subjects only, both parents of non-Asian descent
- Body mass index (BMI) between 23.0 and 34.9 kg/m^2 (both inclusive)
- Body weight greater than or equal to 60 kg
Key exclusion criteria (2 listed)
- Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
- Subjects aged above or equal to 40 years with an estimated 10-year atherosclerotic cardiovascular disease risk (as described in the American College of Cardiology and the American Heart Association Prevention Guideline) greater than or equal to 5 percentage
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 |
|---|---|---|
| NNC0194-04991 single dose administered subcutaneously (s.c. - under the skin) | Drug | NN0194-0499 |
| Placebo (NNC0194-0499 )1 single dose administered subcutaneously (s.c. - under the skin). | Drug | Placebo |
Primary outcome
Number of treatment emergent adverse events (TEAEs)
Time frame: From Day 1 (pre-dose) until completion of the post-treatment period at follow-up (Day 36)
Count of events
9 secondary outcomes
AUC0-∞, SD: The area under the NNC0194-0499 serum concentration-time curve from time 0 to infinity after a single s.c.(subcutaneous) administration
Time frame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
AUC0-tz, SD: The area under the NNC0194-0499 serum concentration-time curve from time 0 to the time of the last quantifiable sample after a single s.c. administration
Time frame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
AUC0-168h, SD: The area under the NNC0194-0499 serum concentration-time curve from time 0 to 168 hours after a single s.c. administration
Time frame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Cmax, SD: Maximum concentration of NNC0194-0499 in serum after a single s.c. administration
Time frame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
tmax, SD: Time from dose administration to maximum serum concentration of NNC0194-0499 after a single s.c. administration
Time frame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
t½, SD: Terminal half-life of NNC0194-0499
Time frame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
CL/FSD: 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/FSD: Apparent volume of distribution of NNC0194-0499 in the terminal phase
Time frame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
MRTSD: The mean residence time of NNC0194-0499 after a single s.c. administration
Time frame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (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 5 Apr 2022.
- Derived from this study: PubMed 41351276Dahl K, Friedrichsen MH, Ribel-Madsen R, Hansen JS, Clausen JO, Axelsen M, Palle MS, Lippert SL, Bjorkdahl O, Toubro S, Key C, Andersen B. Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Novel Long-Acting FGF21 Analog Zalfermin. Clin Transl Sci. 2025 Dec;18(12):e70435. doi: 10.1111/cts.70435.
- 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. 1452) study director
Novo Nordisk A/S
1 site in 1 country: 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 Non-alcoholic Steatohepatitis, run by Novo Nordisk A/S at 1 site in Japan.
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 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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. Some participants in this study may receive a placebo. 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?
Number of treatment emergent adverse events (TEAEs) (time frame: From Day 1 (pre-dose) until completion of the post-treatment period at follow-up (Day 36)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04722653, which also lists 1 linked publication.
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 5 Apr 2022.