A Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of Long-acting Growth Hormone (Somapacitan) Compared to Daily Dosing of Norditropin® SimpleXx® in Children With Growth Hormone Deficiency

Growth Hormone Disorder Clinical Trial

Official title:

A Randomised, Open-labelled, Active-controlled, Multinational, Dose-escalation Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of Long-acting Growth Hormone (NNC0195-0092, Somapacitan) Compared to Daily Dosing of Norditropin® SimpleXx® in Children With Growth Hormone Deficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01973244
• Other study ID #: NN8640-4042
• Secondary ID: 2013-000013-20U1
• Status: Completed
• Phase: Phase 1
• Start date: December 16, 2013
• Est. completion date: November 4, 2014

Study information

• Verified date: December 2020
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 4, 2014
• Est. primary completion date: November 4, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 13 Years

Eligibility

Inclusion Criteria:

• Confirmed diagnosis of GHD (growth hormone deficiency) as defined by two different GH (growth hormone) stimulation tests, peak GH level below or equal to 7.0 ng/ml. For children with three or more pituitary hormone deficiencies only one GH stimulation test will be needed. If in accordance with country specific practice, growth hormone deficiency can be defined by only one GH stimulation test, peak GH level below or equal to 7.0 ng/ml.
• Pre-pubertal children at screening. Boys: Tanner stage 1 and age above or equal to 6 years and below 13 years. Girls: Tanner stage 1 and age above or equal to 6 years and below 12 years
• Body weight above or equal to 16.0 kg and below or equal to 50.0 kg
• Stable GH replacement treatment for at least 3 months

Exclusion Criteria:

• History or presence of malignancy
• Overt diabetes mellitus (fasting blood glucose above or equal to 7.0 mmol/l)

Related Conditions & MeSH terms

• Dwarfism, Pituitary
• Endocrine System Diseases
• Growth Hormone Deficiency in Children
• Growth Hormone Disorder

Intervention

Drug:
• somapacitan
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.
• somatropin
Administered subcutaneously (s.c., under the skin) once daily for 7 days. The daily dose is 0.03 mg/kg/day.

Locations

Country	Name	City	State
Austria	Novo Nordisk Investigational Site	Graz
Austria	Novo Nordisk Investigational Site	Linz
Austria	Novo Nordisk Investigational Site	Wien
Belgium	Novo Nordisk Investigational Site	Brussel
Belgium	Novo Nordisk Investigational Site	Bruxelles
France	Novo Nordisk Investigational Site	Paris
France	Novo Nordisk Investigational Site	Toulouse cedex 9
Israel	Novo Nordisk Investigational Site	Haifa
Israel	Novo Nordisk Investigational Site	Jerusalem
Israel	Novo Nordisk Investigational Site	Kfar Saba
Israel	Novo Nordisk Investigational Site	Petah Tikva
Israel	Novo Nordisk Investigational Site	Tel Hashomer
North Macedonia	Novo Nordisk Investigational Site	Skopje
Norway	Novo Nordisk Investigational Site	Bergen
Slovenia	Novo Nordisk Investigational Site	Ljubljana
Spain	Novo Nordisk Investigational Site	Barcelona
Spain	Novo Nordisk Investigational Site	Esplugues Llobregat(Barcelona)
Spain	Novo Nordisk Investigational Site	Santiago de Compostela
Spain	Novo Nordisk Investigational Site	Vitoria
Sweden	Novo Nordisk Investigational Site	Stockholm
Switzerland	Novo Nordisk Investigational Site	Basel
Switzerland	Novo Nordisk Investigational Site	Genève

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Austria,  Belgium,  France,  Israel,  North Macedonia,  Norway,  Slovenia,  Spain,  Sweden,  Switzerland, 

References & Publications (1)

Juul Kildemoes R, Højby Rasmussen M, Agersø H, Overgaard RV. Optimal Monitoring of Weekly IGF-I Levels During Growth Hormone Therapy With Once-Weekly Somapacitan. J Clin Endocrinol Metab. 2020 Dec 12. pii: dgaa775. doi: 10.1210/clinem/dgaa775. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events (AEs)		From first administration of trial product and up until day 35 (final visit)
Secondary	The area under the insulin-like growth factor I (IGF-I) concentration-time curve		From 0 to 168 hours after dosing

External Links

•   Clinical Trials at Novo Nordisk