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NCT01706783 Clinical Trial

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

Adult Growth Hormone Deficiency Clinical Trial

Official title:
A Randomised, Open-labelled, Active-controlled, Multiple Dose, Dose Escalating, Sequential Dose Group Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Once-weekly Long-acting Growth Hormone (NNC0195-0092, Somapacitan) Compared to Once-daily Norditropin NordiFlex® in Adults With Growth Hormone Deficiency

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01706783
Other study ID # NN8640-3947
Secondary ID 2011-005484-24U1
Status Completed
Phase Phase 1
First received
Last updated
Start date October 12, 2012
Est. completion date November 18, 2013

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

Clinical Trial Summary

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).

Recruitment information / eligibility
Status Completed
Enrollment 35
Est. completion date November 18, 2013
Est. primary completion date November 18, 2013
Accepts healthy volunteers No
Gender All
Age group 20 Years to 70 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• somapacitan
Subcutaneous (s.c., under the skin) administration once weekly (Days 1, 8, 15 and 22) of 4 different doses of NNC0195-0092 (somapacitan) in an escalating order
• Norditropin NordiFlex®
Subcutaneous (s.c., under the skin) administration daily for 28 days. The daily dosing will be the same as the pre-trial daily dose of human growth hormone (hGH) taken by the adult with growth hormone deficiency

Locations
Country Name City State
Denmark Novo Nordisk Investigational Site Århus C
Denmark Novo Nordisk Investigational Site København Ø
Denmark Novo Nordisk Investigational Site Odense
Sweden Novo Nordisk Investigational Site Stockholm

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Denmark,  Sweden, 

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 49
Secondary NNC0195-0092 (somapacitan) only: Area under the curve, AUC (0-168h) From 0 to 168 hours
Secondary Norditropin NordiFlex® only: AUC (0-24h) From 0 to 24 hours
Secondary NNC0195-0092 (somapacitan), first dose administration only: AUC (0-168h) From 0 to 168 hours
Secondary Norditropin NordiFlex®, first dose administration only: AUC (0-24h) From 0 to 24 hours
Secondary NNC0195-0092 (somapacitan): Maximum serum concentration (Cmax) From 0 to 168 hours
Secondary Norditropin NordiFlex®: Cmax From 0 to 24 hours
Secondary Insulin-like growth factor I (IGF-I): AUC (0-168h) From 0 to 168 hours
Secondary IGF-I: Cmax From 0 to 168 hours
Secondary Insulin-like growth factor binding protein-3 (IGFBP-3): AUC IGFBP-3(0-168h) From 0 to 168 hours
Secondary IGFBP-3: Cmax From 0 to 168 hours
See also
  Status Clinical Trial Phase
Completed NCT02229851 - Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency. Phase 3
Completed NCT01562834 - Effect of Somatropin on Left Ventricular Mass in Growth Hormone Deficient Adult Patients Phase 4
Completed NCT01822340 - Safety and Efficacy Study of Recombinant Human Growth Hormone in Adult Growth Hormone Deficiency Patients Phase 2
Completed NCT01109017 - Observational Study of the Safety and Efficacy of Norditropin® in Adult Patients With Growth Hormone Deficiency N/A
Completed NCT00184730 - Long-term Trial on Growth Hormone Deficiency in Adults (GHDA) Phase 3
Completed NCT00519558 - Growth Hormone Deficiency in Adults (GHDA) Phase 3
Terminated NCT01698944 - Cardiovascular Effects on Growth Hormone Therapy in Adults With Growth Hormone Deficiency Phase 4
Completed NCT03075644 - A Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone Deficiency Phase 3
Completed NCT02005198 - Assessing the Minimal Important Difference (MID) of the Treatment Related Impact Measure-Adult Growth Hormone Deficiency (TRIM-AGHD) N/A
Terminated NCT01909479 - A Phase 3, Multicenter Study To Evaluate The Efficacy And Safety Of MOD-4023 In Adults With Growth Hormone Deficiency Phase 3
Completed NCT01806298 - An Open-label Phase 4 Study to Explore Immunogenicity of the Liquid Formulation of Saizen® in Subjects With Adult Growth Hormone Deficiency (AGHD) Phase 4
Completed NCT03186495 - Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Various Degrees of Impaired Renal Function Compared to Subjects With Normal Renal Function Phase 1
Not yet recruiting NCT04867317 - Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD) Phase 3
Recruiting NCT05979480 - The Effects of Growth Hormone Treatment Discontinuation in Adults on Metabolic Profile, Body Composition and Quality Of Life (GAMBOL Study)
Completed NCT02526420 - Versartis International Trial in Adults With Long-Acting Growth Hormone Phase 2
Completed NCT00934063 - An Observational Study Validating a Score That Quantifies the Therapeutic Response to Treatment With Norditropin® N/A
Completed NCT00715689 - Dose Study in Growth Hormone Deficient Adults Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083 Phase 2
Completed NCT00297713 - Study of an Extended-Release, Crystalline Formulation of Recombinant Human Growth Hormone (ALTU-238) in Growth Hormone Deficient Adults to Determine Pharmacokinetics, Pharmacodynamics, and Drug Safety Phase 2
Completed NCT01543880 - Safety and Efficacy of Long-term Somatropin Treatment in Adults N/A
Completed NCT01580605 - French National Registry of Adults With Growth Hormone Deficiency Treated With Somatropin

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