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

NCT01706783 | Completed Phase 1

• 3 other identifiers: NN8640-39472011-005484-24U1111-1125-7331
• Study Type: interventional
• Target: 35
• Locations: 2 countries
• Sites: 4

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).

Conditions

Growth Hormone Disorder; Adult Growth Hormone Deficiency

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events (AEs)

  From first administration of trial product and up until Day 49

Secondary Outcomes (10)

• NNC0195-0092 (somapacitan) only: Area under the curve, AUC (0-168h)

  From 0 to 168 hours

• Norditropin NordiFlex® only: AUC (0-24h)

  From 0 to 24 hours

• NNC0195-0092 (somapacitan), first dose administration only: AUC (0-168h)

  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

Study Arms (2)

NNC0195-0092 (somapacitan)

EXPERIMENTAL

Drug: somapacitan

Norditropin NordiFlex®

ACTIVE COMPARATOR

Drug: Norditropin NordiFlex®

Interventions

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

Also known as: NNC0195-0092

NNC0195-0092 (somapacitan)

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

Norditropin NordiFlex®

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (4)

Novo Nordisk Investigational Site

Århus C, 8000, Denmark

Location

Novo Nordisk Investigational Site

København Ø, 2100, Denmark

Location

Novo Nordisk Investigational Site

Odense, 5000, Denmark

Location

Novo Nordisk Investigational Site

Stockholm, 141 86, Sweden

Location

Related Publications (4)

• Juul Kildemoes R, Hojby Rasmussen M, Agerso H, Overgaard RV. Optimal Monitoring of Weekly IGF-I Levels During Growth Hormone Therapy With Once-Weekly Somapacitan. J Clin Endocrinol Metab. 2021 Jan 23;106(2):567-576. doi: 10.1210/clinem/dgaa775.

  PMID: 33313798 BACKGROUND

• Papathanasiou T, Agerso H, Damholt BB, Hojby Rasmussen M, Kildemoes RJ. Population Pharmacokinetics and Pharmacodynamics of Once-Daily Growth Hormone Norditropin(R) in Children and Adults. Clin Pharmacokinet. 2021 Sep;60(9):1217-1226. doi: 10.1007/s40262-021-01011-3. Epub 2021 Apr 17.

  PMID: 33864240 DERIVED

• Juul RV, Rasmussen MH, Agerso H, Overgaard RV. Pharmacokinetics and Pharmacodynamics of Once-Weekly Somapacitan in Children and Adults: Supporting Dosing Rationales with a Model-Based Analysis of Three Phase I Trials. Clin Pharmacokinet. 2019 Jan;58(1):63-75. doi: 10.1007/s40262-018-0662-5.

  PMID: 29671202 DERIVED

• Rasmussen MH, Janukonyte J, Klose M, Marina D, Tanvig M, Nielsen LF, Hoybye C, Andersen M, Feldt-Rasmussen U, Christiansen JS. Reversible Albumin-Binding GH Possesses a Potential Once-Weekly Treatment Profile in Adult Growth Hormone Deficiency. J Clin Endocrinol Metab. 2016 Mar;101(3):988-98. doi: 10.1210/jc.2015-1991. Epub 2016 Jan 4.

  PMID: 26727076 DERIVED

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Dwarfism, Pituitary

Interventions

somapacitan; NNC0195-0092; Growth Hormone

Condition Hierarchy (Ancestors)

Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Hypopituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Global Clinical Registry (GCR,1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2012
• First Posted: October 15, 2012
• Study Start: October 12, 2012
• Primary Completion: November 18, 2013
• Study Completion: November 18, 2013
• Last Updated: December 24, 2020

Record last verified: 2020-12

Locations

SE (1); DK (3)