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
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
Status
Completed
Phase
Phase 1
Enrollment
35
Locations
4
Results
Not posted
Publications
4
Study summary
What the protocol is testing.
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).
Interventions
Treatment arms and agents.
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
Timeline
From registration to results.
First posted
Oct 15, 2012
Study start
Oct 12, 2012
Primary completion
Nov 18, 2013
Study completion
Nov 18, 2013
Results posted
Not reported
Registry updated
Dec 24, 2020
Outcomes
What the study measures.
Primary outcomes
Incidence of adverse events (AEs)
Time frame · From first administration of trial product and up until Day 49
Secondary outcomes
NNC0195-0092 (somapacitan) only: Area under the curve, AUC (0-168h)
Time frame · From 0 to 168 hours
Norditropin NordiFlex® only: AUC (0-24h)
Time frame · From 0 to 24 hours
NNC0195-0092 (somapacitan), first dose administration only: AUC (0-168h)
Time frame · From 0 to 168 hours
Norditropin NordiFlex®, first dose administration only: AUC (0-24h)
Time frame · From 0 to 24 hours
NNC0195-0092 (somapacitan): Maximum serum concentration (Cmax)
Time frame · From 0 to 168 hours
Norditropin NordiFlex®: Cmax
Time frame · From 0 to 24 hours
Insulin-like growth factor I (IGF-I): AUC (0-168h)
Time frame · From 0 to 168 hours
IGF-I: Cmax
Time frame · From 0 to 168 hours
Insulin-like growth factor binding protein-3 (IGFBP-3): AUC IGFBP-3(0-168h)
Time frame · From 0 to 168 hours
IGFBP-3: Cmax
Time frame · From 0 to 168 hours
Eligibility
Who can take part.
- Minimum age
- 20 Years
- Maximum age
- 70 Years
- Sex
- ALL
- 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
Study locations
4 registered sites.
Denmark · Sweden. Showing up to 24 locations stored in the fast local snapshot.
Novo Nordisk Investigational Site
Århus C, Denmark
Novo Nordisk Investigational Site
København Ø, Denmark
Novo Nordisk Investigational Site
Odense, Denmark
Novo Nordisk Investigational Site
Stockholm, Sweden
Publications
Results and literature.
PMID 33313798 ↗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 33864240 ↗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 29671202 ↗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 26727076 ↗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.
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Related PeptideStat pages
Put the record in context.
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