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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

Primary Purpose

Growth Hormone Disorder, Adult Growth Hormone Deficiency

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
somapacitan
Norditropin NordiFlex®
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Growth Hormone Disorder

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NNC0195-0092 (somapacitan)

Norditropin NordiFlex®

Arm Description

Outcomes

Primary Outcome Measures

Incidence of adverse events (AEs)

Secondary Outcome Measures

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

Full Information

First Posted
October 11, 2012
Last Updated
December 22, 2020
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01706783
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
October 12, 2012 (Actual)
Primary Completion Date
November 18, 2013 (Actual)
Study Completion Date
November 18, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Growth Hormone Disorder, Adult Growth Hormone Deficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NNC0195-0092 (somapacitan)
Arm Type
Experimental
Arm Title
Norditropin NordiFlex®
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
somapacitan
Other Intervention Name(s)
NNC0195-0092
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Norditropin NordiFlex®
Intervention Description
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 Measure Information:
Title
Incidence of adverse events (AEs)
Time Frame
From first administration of trial product and up until Day 49
Secondary Outcome Measure Information:
Title
NNC0195-0092 (somapacitan) only: Area under the curve, AUC (0-168h)
Time Frame
From 0 to 168 hours
Title
Norditropin NordiFlex® only: AUC (0-24h)
Time Frame
From 0 to 24 hours
Title
NNC0195-0092 (somapacitan), first dose administration only: AUC (0-168h)
Time Frame
From 0 to 168 hours
Title
Norditropin NordiFlex®, first dose administration only: AUC (0-24h)
Time Frame
From 0 to 24 hours
Title
NNC0195-0092 (somapacitan): Maximum serum concentration (Cmax)
Time Frame
From 0 to 168 hours
Title
Norditropin NordiFlex®: Cmax
Time Frame
From 0 to 24 hours
Title
Insulin-like growth factor I (IGF-I): AUC (0-168h)
Time Frame
From 0 to 168 hours
Title
IGF-I: Cmax
Time Frame
From 0 to 168 hours
Title
Insulin-like growth factor binding protein-3 (IGFBP-3): AUC IGFBP-3(0-168h)
Time Frame
From 0 to 168 hours
Title
IGFBP-3: Cmax
Time Frame
From 0 to 168 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR,1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
København Ø
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Århus C
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
33313798
Citation
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.
Results Reference
background
PubMed Identifier
33864240
Citation
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.
Results Reference
derived
PubMed Identifier
29671202
Citation
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.
Results Reference
derived
PubMed Identifier
26727076
Citation
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.
Results Reference
derived
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

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

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