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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01706783
Recruitment Status : Completed
First Posted : October 15, 2012
Last Update Posted : May 25, 2018
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Growth Hormone Disorder Adult Growth Hormone Deficiency Drug: somapacitan Drug: Norditropin NordiFlex® Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 12, 2012
Actual Primary Completion Date : November 18, 2013
Actual Study Completion Date : November 18, 2013

Arm Intervention/treatment
Experimental: NNC0195-0092 (somapacitan) 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
Other Name: NNC0195-0092

Active Comparator: Norditropin NordiFlex® Drug: 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

Primary Outcome Measures :
  1. Incidence of adverse events (AEs) [ Time Frame: From first administration of trial product and up until Day 49 ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01706783

Novo Nordisk Investigational Site
København Ø, Denmark, 2100
Novo Nordisk Investigational Site
Odense, Denmark, 5000
Novo Nordisk Investigational Site
Århus C, Denmark, 8000
Novo Nordisk Investigational Site
Stockholm, Sweden, 141 86
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR,1452) Novo Nordisk A/S

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Novo Nordisk A/S Identifier: NCT01706783     History of Changes
Other Study ID Numbers: NN8640-3947
2011-005484-24 ( EudraCT Number )
U1111-1125-7331 ( Other Identifier: WHO )
First Posted: October 15, 2012    Key Record Dates
Last Update Posted: May 25, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
Endocrine System Diseases
Dwarfism, Pituitary
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs