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NCT Number: NCT01706783

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

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).

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Key information

Conditions

Growth Hormone Disorder Adult Growth Hormone Deficiency Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Dwarfism Dwarfism, Pituitary Endocrine System Diseases Hypopituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site, København Ø, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Somapacitan

Drug

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 names: NNC0195-0092

Norditropin NordiFlex®

Drug

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 outcomes

  1. Incidence of adverse events (AEs)

    Time frame: From first administration of trial product and up until Day 49

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 15, 2012
Registry last updated
Dec 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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