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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1181-9045 | Other Identifier | WHO |
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This trial is conducted in The United States of America. The aim of this trial is to investigate Safety, Tolerability and Pharmacokinetics (the exposure of the trial drug in the body) of NNC0194-0499 in Male Subjects with Overweight or Obesity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC0194-0499 | Experimental | Injected s.c. /subcutaneously (under the skin) |
|
| Placebo | Placebo Comparator | Injected s.c. /subcutaneously (under the skin) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0194-0499 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment-emergent adverse events (TEAEs) | From time of administration of NNC0194-0499 (day 1) to completion of the post-treatment period at follow-up (day 36) |
| Measure | Description | Time Frame |
|---|---|---|
| The area under the NNC0194-0499 serum concentration-time curve after a single subcutaneous administration | From pre-dose (day 1) until the followup (day 36) | |
| The maximum concentration of NNC0194-0499 in serum after a single subcutaneous administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR,1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | San Antonio | Texas | 78209 | United States |
| 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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|
| From pre-dose (day 1) until the followup (day 36) |
| The time to maximum concentration of NNC0194-0499 in serum after a single subcutaneous administration | From pre-dose (day 1) until the followup (day 36) |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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