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
• 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
• 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

Related Conditions & MeSH terms

• Adult Growth Hormone Deficiency
• Dwarfism, Pituitary
• Endocrine System Diseases
• Growth Hormone Disorder

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

External Links

•   Clinical Trials at Novo Nordisk