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Trial · Interventional

CompletedPhase 1Registry data

A Trial Investigating the Safety, Tolerability, Availability and Distribution in the Body of Once-weekly Long-acting Growth Hormone (Somapacitan) Compared to Once Daily Norditropin NordiFlex® in Adults With Growth Hormone Deficiency

NCTNCT01706783 (opens ClinicalTrials.gov in a new tab)Other idNN8640-3947Other id2011-005484-24Other idU1111-1125-7331
Open at ClinicalTrials.govAsk about this trial

Overview

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

Denmark, Sweden

Start
12 Oct 2012
Primary completion
18 Nov 2013
Completion
18 Nov 2013
First posted
15 Oct 2012 (estimated)
Last update posted
24 Dec 2020
Conditions
Growth Hormone Disorder · Adult Growth Hormone Deficiency

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201220132014
  1. Ph 1

    A Trial Investigating the Safety, Tolerability, Availability and Distribution in the Body of Once-weekly Long-acting Growth Hormone (Somapacitan) Compared to Once Daily Norditropin NordiFlex® in Adults With Growth Hormone Deficiency

    NCT01706783

    12 Oct 2012 to 18 Nov 2013

Registry summary

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

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).

Interventions

  • somapacitanDrug
  • Norditropin NordiFlex®Drug

Arms2

  • Experimental

    NNC0195-0092 (somapacitan)

  • Active comparator

    Norditropin NordiFlex®

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 49

Secondary outcomes(10)

  1. NNC0195-0092 (somapacitan) only: Area under the curve, AUC (0-168h)

    Time frame · From 0 to 168 hours

  2. Norditropin NordiFlex® only: AUC (0-24h)

    Time frame · From 0 to 24 hours

  3. NNC0195-0092 (somapacitan), first dose administration only: AUC (0-168h)

    Time frame · From 0 to 168 hours

  4. Norditropin NordiFlex®, first dose administration only: AUC (0-24h)

    Time frame · From 0 to 24 hours

  5. NNC0195-0092 (somapacitan): Maximum serum concentration (Cmax)

    Time frame · From 0 to 168 hours

  6. Norditropin NordiFlex®: Cmax

    Time frame · From 0 to 24 hours

  7. Insulin-like growth factor I (IGF-I): AUC (0-168h)

    Time frame · From 0 to 168 hours

  8. IGF-I: Cmax

    Time frame · From 0 to 168 hours

  9. Insulin-like growth factor binding protein-3 (IGFBP-3): AUC IGFBP-3(0-168h)

    Time frame · From 0 to 168 hours

  10. IGFBP-3: Cmax

    Time frame · From 0 to 168 hours

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

Studies3

Studies that cite this trial.

Studies with results

0 studies on this page

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

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

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedRasmussen 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. PMID 26727076

Eligibility

Who could join, as posted.

Sex
All
Age
from 20 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Adults with GHD as defined in the consensus guidelines for the diagnosis and treatment of adults with GHD * Stable human growth hormone (hGH) replacement therapy for at least 3 months Exclusion Criteria: * Participation in another clinical trial within 3 months or receipt of any investigational medicinal product within 3 months prior to randomisation * Active malignant disease or malignant disease within the last 5 years with exception of fully treated local basal cell carcinoma or carcinoma in situ of cervix * Proliferative retinopathy judged by retina-photo within the last year - only with concomitant diabetes * Heart insufficiency, New York Heart Association (NYHA) class above 2 * Adults with GHD with poorly controlled diabetes mellitus with a glycosylated haemoglobin (HbA1c) 64 mmol/mol (8.0%) and/or insulin treatment * Stable pituitary replacement therapy for less than 3 months

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