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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000013-20 | EudraCT Number | ||
| U1111-1138-2206 | Other Identifier | WHO | |
| REec-2014-0688 | Registry Identifier | Spanish Register of Clinical Studies (REec) | |
| JapicCTI-142663 | Registry Identifier | JAPIC |
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This trial is conducted in Europe and Asia. The aim of the trial is to investigate safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of a single dose of long-acting growth hormone (NNC0195-0092, somapacitan) compared to daily dosing of Norditropin® SimpleXx® (somatropin) in children with growth hormone deficiency.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC0195-0092 (somapacitan) | Experimental |
| |
| Norditropin® | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| somapacitan | Drug | A single dose administered subcutaneously (s.c., under the skin) of 4 different doses of NNC0195-0092 in an escalating order. Each subject will be allocated to one dose level only. After completion of each dose cohort, a safety evaluation will be conducted prior to dose escalation. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) | From first administration of trial product and up until day 35 (final visit) |
| Measure | Description | Time Frame |
|---|---|---|
| The area under the insulin-like growth factor I (IGF-I) concentration-time curve | From 0 to 168 hours after dosing |
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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 | Graz | 8036 | Austria | |||
| 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. | |
| 42369274 | Derived | Desrochers J, Backeljauw P, Hojby M, Juul Kildemoes R, Linglart A, Mori J, Leisegang RF. Model-based somapacitan dosing and IGF-I response in children born SGA or with ISS, Noonan or Turner syndromes. J Endocr Soc. 2026 Jun 4;10(7):bvag124. doi: 10.1210/jendso/bvag124. eCollection 2026 Jul. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| somatropin | Drug | Administered subcutaneously (s.c., under the skin) once daily for 7 days. The daily dose is 0.03 mg/kg/day. |
|
| Linz |
| 4020 |
| Austria |
| Novo Nordisk Investigational Site | Vienna | A 1090 | Austria |
| Novo Nordisk Investigational Site | Brussels | 1090 | Belgium |
| Novo Nordisk Investigational Site | Brussels | 1200 | Belgium |
| Novo Nordisk Investigational Site | Paris | 75015 | France |
| Novo Nordisk Investigational Site | Toulouse | 31059 | France |
| Novo Nordisk Investigational Site | Haifa | 31096 | Israel |
| Novo Nordisk Investigational Site | Jerusalem | 91240 | Israel |
| Novo Nordisk Investigational Site | Kfar Saba | 44281 | Israel |
| Novo Nordisk Investigational Site | Petah Tikva | 49202 | Israel |
| Novo Nordisk Investigational Site | Tel Litwinsky | 52621 | Israel |
| Novo Nordisk Investigational Site | Skopje | 1000 | North Macedonia |
| Novo Nordisk Investigational Site | Bergen | 5021 | Norway |
| Novo Nordisk Investigational Site | Ljubljana | 1525 | Slovenia |
| Novo Nordisk Investigational Site | Barcelona | 08035 | Spain |
| Novo Nordisk Investigational Site | Esplugues Llobregat(Barcelona) | 08950 | Spain |
| Novo Nordisk Investigational Site | Santiago de Compostela | 15706 | Spain |
| Novo Nordisk Investigational Site | Vitoria-Gasteiz | 01009 | Spain |
| Novo Nordisk Investigational Site | Stockholm | 141 86 | Sweden |
| Novo Nordisk Investigational Site | Basel | 4031 | Switzerland |
| Novo Nordisk Investigational Site | Geneva | 1211 | Switzerland |
| 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. |
| 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. |
| 28656605 | Derived | Battelino T, Rasmussen MH, De Schepper J, Zuckerman-Levin N, Gucev Z, Savendahl L; NN8640-4042 Study Group. Somapacitan, a once-weekly reversible albumin-binding GH derivative, in children with GH deficiency: A randomized dose-escalation trial. Clin Endocrinol (Oxf). 2017 Oct;87(4):350-358. doi: 10.1111/cen.13409. Epub 2017 Aug 8. |
| ID | Term |
|---|---|
| C000718308 | somapacitan |
| C000594654 | NNC0195-0092 |
| D019382 | Human Growth Hormone |
| ID | Term |
|---|---|
| D013006 | Growth Hormone |
| 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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