A trial investigating the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiency

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) compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiency

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-000013-20-SI

Enrollment

Registered

2013-09-20

Start date

2013-12-09

Completion date

Unknown

Last updated

2015-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Growth hormone deficiency in children MedDRA version: 14.1 Level: PT Classification code 10056438 Term: Growth hormone deficiency System Organ Class: 10014698 - Endocrine disorders

Interventions

Product Code: NNC0195-0092 DP 6.7 mg ml 3 ml cartridge Pharmaceutical Form: Solution for injection in cartridge INN or Proposed INN: n/a CAS Number: 1338578-34-9 Other descriptive name: NNC0195-0092 C

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Confirmed diagnosis of GHD as defined by two different GH stimulation tests, peak GH level = 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 = 7.0 ng/mL. - Pre-pubertal children at screening: - Boys: Tanner stage 1 and age = 6 year and =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - History or presence of malignancy - Overt diabetes mellitus (fasting blood glucose = 7.0 mmol/L)

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate safety and tolerability of a single subcutaneous (s.c.) dose of NNC0195-0092 compared to daily dosing of Norditropin® SimpleXx® for seven days in children with growth hormone deficiency (GHD);Secondary Objective: - To evaluate pharmacokinetics (PK) and pharmacodynamics (PD) of a single s.c. dose of NNC0195-0092 in children with GHD - To evaluate local tolerability (i.e. injection site reactions) of a single s.c. dose of NNC0195-0092 compared to daily dosing of Norditropin® SimpleXx® for seven days in children with GHD ;Primary end point(s): Incidence of adverse events (AEs) ;Timepoint(s) of evaluation of this end point: From first administration of trial product and up until day 35 (final visit)	—

Measure

Time frame

Main Objective: To evaluate safety and tolerability of a single subcutaneous (s.c.) dose of NNC0195-0092 compared to daily dosing of Norditropin® SimpleXx® for seven days in children with growth hormone deficiency (GHD);Secondary Objective: - To evaluate pharmacokinetics (PK) and pharmacodynamics (PD) of a single s.c. dose of NNC0195-0092 in children with GHD - To evaluate local tolerability (i.e. injection site reactions) of a single s.c. dose of NNC0195-0092 compared to daily dosing of Norditropin® SimpleXx® for seven days in children with GHD ;Primary end point(s): Incidence of adverse events (AEs) ;Timepoint(s) of evaluation of this end point: From first administration of trial product and up until day 35 (final visit)

—

Secondary

Measure	Time frame
Secondary end point(s): The area under the insulin-like growth factor I (IGF-I) concentration-time curve ;Timepoint(s) of evaluation of this end point: From 0 to 168 hours after dosing	—

Countries

Austria, Belgium, European Union, Israel, Macedonia, the former Yugoslav Republic of, Norway, Slovenia, Spain, Sweden, Switzerland

Contacts

Public ContactGlobal Clinical Registry (GCR,1452)

Novo Nordisk A/S

clinicaltrials@novonordisk.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026