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Trial · Interventional

CompletedPhase 1Registry data

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

NCTNCT01973244 (opens ClinicalTrials.gov in a new tab)Other idNN8640-4042Other id2013-000013-20Other idU1111-1138-2206Other idREec-2014-0688
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
32 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Open label (no masking)
Countries
10 countries

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

Start
16 Dec 2013
Primary completion
4 Nov 2014
Completion
4 Nov 2014
First posted
31 Oct 2013 (estimated)
Last update posted
24 Dec 2020
Conditions
Growth Hormone Disorder · Growth Hormone Deficiency in Children

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201320142015
  1. Ph 1

    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

    NCT01973244

    16 Dec 2013 to 4 Nov 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • somapacitanDrug
  • somatropinDrug

Arms2

  • Experimental

    NNC0195-0092 (somapacitan)

  • Active comparator

    Norditropin®

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Incidence of adverse events (AEs)

    Time frame · From first administration of trial product and up until day 35 (final visit)

Secondary outcomes(1)

  1. The area under the insulin-like growth factor I (IGF-I) concentration-time curve

    Time frame · From 0 to 168 hours after dosing

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies5

Studies that cite this trial.

Studies with results

1 study on this page

PubMed tag: none · 2026

Model-based somapacitan dosing and IGF-I response in children born SGA or with ISS, Noonan or Turner syndromes.

Desrochers et al. 2026Journal of the Endocrine Society

PMID 42369274PMC13306058DOI 10.1210/jendso/bvag124PUB-42369274

CC BY
Download PDF

Indexing hint: Randomized controlled trial · 2019

Pharmacokinetics and Pharmacodynamics of Once-Weekly Somapacitan in Children and Adults: Supporting Dosing Rationales with a Model-Based Analysis of Three Phase I Trials.

Juul et al. 2019Clinical pharmacokineticscited by 29

PMID 29671202PMC6325982DOI 10.1007/s40262-018-0662-5PUB-29671202

Free to read · publisher termsCC BY-NC
Read at source

Indexing hint: Randomized controlled trial · 2017

14 results

Somapacitan, a once-weekly reversible albumin-binding GH derivative, in children with GH deficiency: A randomized dose-escalation trial.

Battelino et al. 2017Clinical endocrinologycited by 48

PMID 28656605DOI 10.1111/cen.13409PUB-28656605

Full text at the publisher14 results
Publisher pageSee results (14)

More studies

2 studies on this page

PubMed tag: none · 2021

Optimal Monitoring of Weekly IGF-I Levels During Growth Hormone Therapy With Once-Weekly Somapacitan.

Juul Kildemoes et al. 2021The Journal of clinical endocrinology and metabolismcited by 30

PMID 33313798PMC7823237DOI 10.1210/clinem/dgaa775PUB-33313798

CC BY
Download PDF

Indexing hint: Meta-analysis (pooled) · 2021

Population Pharmacokinetics and Pharmacodynamics of Once-Daily Growth Hormone Norditropin® in Children and Adults.

Papathanasiou et al. 2021Clinical pharmacokineticscited by 8

PMID 33864240PMC8416863DOI 10.1007/s40262-021-01011-3PUB-33864240

Free to read · publisher termsCC BY-NC
Read at source

Eligibility

Who could join, as posted.

Sex
All
Age
from 6 Years up to 13 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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)

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