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

Phase 1

Completed

• Conditions: Growth Hormone Disorder; Adult Growth Hormone Deficiency
• Interventions: Drug: somapacitan; Drug: Norditropin NordiFlex®

• Registration Number: NCT01706783
• Lead Sponsor: Novo Nordisk A/S

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-11
• Study First Submitted QC: 2012-10-11
• Study Start: 2012-10-12
• Study First Posted: 2012-10-15
• Primary Completion: 2013-11-18
• Study Completion: 2013-11-18
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-22
• Last Update Posted: 2020-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NNC0195-0092 (somapacitan)	somapacitan	-
Norditropin NordiFlex®	Norditropin NordiFlex®	-

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events (AEs)	From first administration of trial product and up until Day 49

Secondary Outcome Measures

Name	Time	Method
Norditropin NordiFlex® only: AUC (0-24h)	From 0 to 24 hours
NNC0195-0092 (somapacitan) only: Area under the curve, AUC (0-168h)	From 0 to 168 hours
NNC0195-0092 (somapacitan), first dose administration only: AUC (0-168h)	From 0 to 168 hours
Norditropin NordiFlex®: Cmax	From 0 to 24 hours
Insulin-like growth factor I (IGF-I): AUC (0-168h)	From 0 to 168 hours
IGF-I: Cmax	From 0 to 168 hours
Norditropin NordiFlex®, first dose administration only: AUC (0-24h)	From 0 to 24 hours
NNC0195-0092 (somapacitan): Maximum serum concentration (Cmax)	From 0 to 168 hours
Insulin-like growth factor binding protein-3 (IGFBP-3): AUC IGFBP-3(0-168h)	From 0 to 168 hours
IGFBP-3: Cmax	From 0 to 168 hours

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇸🇪 Stockholm, Sweden