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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-005484-24 | EudraCT Number | ||
| U1111-1125-7331 | Other Identifier | WHO |
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This trial is conducted in Europe. The aim of the trial is to investigate the safety, tolerability, availability and distribution in the body of once-weekly long-acting growth hormone (NNC0195-0092, somapacitan) compared to once daily Norditropin NordiFlex® in adults with growth hormone deficiency (GHD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC0195-0092 (somapacitan) | Experimental |
| |
| Norditropin NordiFlex® | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| somapacitan | Drug | Subcutaneous (s.c., under the skin) administration once weekly (Days 1, 8, 15 and 22) of 4 different doses of NNC0195-0092 (somapacitan) in an escalating order |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) | From first administration of trial product and up until Day 49 |
| Measure | Description | Time Frame |
|---|---|---|
| NNC0195-0092 (somapacitan) only: Area under the curve, AUC (0-168h) | From 0 to 168 hours | |
| Norditropin NordiFlex® only: AUC (0-24h) | From 0 to 24 hours | |
| NNC0195-0092 (somapacitan), first dose administration only: AUC (0-168h) |
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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 | Århus C | 8000 | Denmark | |||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33313798 | Background | Juul Kildemoes R, Hojby Rasmussen M, Agerso H, Overgaard RV. Optimal Monitoring of Weekly IGF-I Levels During Growth Hormone Therapy With Once-Weekly Somapacitan. J Clin Endocrinol Metab. 2021 Jan 23;106(2):567-576. doi: 10.1210/clinem/dgaa775. | |
| 33864240 | Derived | Papathanasiou T, Agerso H, Damholt BB, Hojby Rasmussen M, Kildemoes RJ. Population Pharmacokinetics and Pharmacodynamics of Once-Daily Growth Hormone Norditropin(R) in Children and Adults. Clin Pharmacokinet. 2021 Sep;60(9):1217-1226. doi: 10.1007/s40262-021-01011-3. Epub 2021 Apr 17. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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|
| Norditropin NordiFlex® | Drug | Subcutaneous (s.c., under the skin) administration daily for 28 days. The daily dosing will be the same as the pre-trial daily dose of human growth hormone (hGH) taken by the adult with growth hormone deficiency |
|
| From 0 to 168 hours |
| Norditropin NordiFlex®, first dose administration only: AUC (0-24h) | From 0 to 24 hours |
| NNC0195-0092 (somapacitan): Maximum serum concentration (Cmax) | From 0 to 168 hours |
| Norditropin NordiFlex®: Cmax | From 0 to 24 hours |
| Insulin-like growth factor I (IGF-I): AUC (0-168h) | From 0 to 168 hours |
| IGF-I: Cmax | From 0 to 168 hours |
| Insulin-like growth factor binding protein-3 (IGFBP-3): AUC IGFBP-3(0-168h) | From 0 to 168 hours |
| IGFBP-3: Cmax | From 0 to 168 hours |
| København Ø |
| 2100 |
| Denmark |
| Novo Nordisk Investigational Site | Odense | 5000 | Denmark |
| Novo Nordisk Investigational Site | Stockholm | 141 86 | Sweden |
| 29671202 | Derived | Juul RV, Rasmussen MH, Agerso H, Overgaard RV. Pharmacokinetics and Pharmacodynamics of Once-Weekly Somapacitan in Children and Adults: Supporting Dosing Rationales with a Model-Based Analysis of Three Phase I Trials. Clin Pharmacokinet. 2019 Jan;58(1):63-75. doi: 10.1007/s40262-018-0662-5. |
| 26727076 | Derived | Rasmussen MH, Janukonyte J, Klose M, Marina D, Tanvig M, Nielsen LF, Hoybye C, Andersen M, Feldt-Rasmussen U, Christiansen JS. Reversible Albumin-Binding GH Possesses a Potential Once-Weekly Treatment Profile in Adult Growth Hormone Deficiency. J Clin Endocrinol Metab. 2016 Mar;101(3):988-98. doi: 10.1210/jc.2015-1991. Epub 2016 Jan 4. |
| ID | Term |
|---|---|
| D004393 | Dwarfism, Pituitary |
| ID | Term |
|---|---|
| D004392 | Dwarfism |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001849 | Bone Diseases, Endocrine |
| D007018 | Hypopituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000718308 | somapacitan |
| C000594654 | NNC0195-0092 |
| D013006 | Growth Hormone |
| ID | Term |
|---|---|
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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