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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1255-1392 | Other Identifier | World Health Organization (WHO) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Placebo | Placebo Comparator | Japanese participants will be randomised 3:1 to receive either a single dose of NNC0194-0499 or placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0194-0499 | Drug | 1 single dose administered subcutaneously (s.c. - under the skin) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment emergent adverse events (TEAEs) | Count of events | From Day 1 (pre-dose) until completion of the post-treatment period at follow-up (Day 36) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Tokyo | 130-0004 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41351276 | Derived | 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. |
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According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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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
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The non-Asian part is run in parallel to the Japanese part in an open design. The Japanese part is double-blinded. Sponsor staff involved in the clinical trial is masked according to company standard procedures.
| Placebo (NNC0194-0499 ) |
| Drug |
1 single dose administered subcutaneously (s.c. - under the skin). |
|
h·nmol/L |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36) |