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

December 22, 2020 updated by: Novo Nordisk A/S

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • København Ø, Denmark, 2100
        • Novo Nordisk Investigational Site
      • Odense, Denmark, 5000
        • Novo Nordisk Investigational Site
      • Århus C, Denmark, 8000
        • Novo Nordisk Investigational Site
  • Sweden
      • Stockholm, Sweden, 141 86
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events (AEs)
Time Frame: From first administration of trial product and up until Day 49
From first administration of trial product and up until Day 49

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 12, 2012

Primary Completion (Actual)

November 18, 2013

Study Completion (Actual)

November 18, 2013

Study Registration Dates

First Submitted

October 11, 2012

First Submitted That Met QC Criteria

October 11, 2012

First Posted (Estimate)

October 15, 2012

Study Record Updates

Last Update Posted (Actual)

December 24, 2020

Last Update Submitted That Met QC Criteria

December 22, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN8640-3947
  • 2011-005484-24 (EudraCT Number)
  • U1111-1125-7331 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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