<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01706783</url>
  </required_header>
  <id_info>
    <org_study_id>NN8640-3947</org_study_id>
    <secondary_id>2011-005484-24</secondary_id>
    <secondary_id>U1111-1125-7331</secondary_id>
    <nct_id>NCT01706783</nct_id>
  </id_info>
  <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</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novo Nordisk A/S</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novo Nordisk A/S</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial is conducted in Europe. The aim of the trial is to investigate the safety,&#xD;
      tolerability, availability and distribution in the body of once-weekly long-acting growth&#xD;
      hormone (NNC0195-0092, somapacitan) compared to once daily Norditropin NordiFlex® in adults&#xD;
      with growth hormone deficiency (GHD).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 12, 2012</start_date>
  <completion_date type="Actual">November 18, 2013</completion_date>
  <primary_completion_date type="Actual">November 18, 2013</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of adverse events (AEs)</measure>
    <time_frame>From first administration of trial product and up until Day 49</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>NNC0195-0092 (somapacitan) only: Area under the curve, AUC (0-168h)</measure>
    <time_frame>From 0 to 168 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Norditropin NordiFlex® only: AUC (0-24h)</measure>
    <time_frame>From 0 to 24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NNC0195-0092 (somapacitan), first dose administration only: AUC (0-168h)</measure>
    <time_frame>From 0 to 168 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Norditropin NordiFlex®, first dose administration only: AUC (0-24h)</measure>
    <time_frame>From 0 to 24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NNC0195-0092 (somapacitan): Maximum serum concentration (Cmax)</measure>
    <time_frame>From 0 to 168 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Norditropin NordiFlex®: Cmax</measure>
    <time_frame>From 0 to 24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insulin-like growth factor I (IGF-I): AUC (0-168h)</measure>
    <time_frame>From 0 to 168 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IGF-I: Cmax</measure>
    <time_frame>From 0 to 168 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insulin-like growth factor binding protein-3 (IGFBP-3): AUC IGFBP-3(0-168h)</measure>
    <time_frame>From 0 to 168 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IGFBP-3: Cmax</measure>
    <time_frame>From 0 to 168 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Growth Hormone Disorder</condition>
  <condition>Adult Growth Hormone Deficiency</condition>
  <arm_group>
    <arm_group_label>NNC0195-0092 (somapacitan)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Norditropin NordiFlex®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>somapacitan</intervention_name>
    <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</description>
    <arm_group_label>NNC0195-0092 (somapacitan)</arm_group_label>
    <other_name>NNC0195-0092</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Norditropin NordiFlex®</intervention_name>
    <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</description>
    <arm_group_label>Norditropin NordiFlex®</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults with GHD as defined in the consensus guidelines for the diagnosis and treatment&#xD;
             of adults with GHD&#xD;
&#xD;
          -  Stable human growth hormone (hGH) replacement therapy for at least 3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participation in another clinical trial within 3 months or receipt of any&#xD;
             investigational medicinal product within 3 months prior to randomisation&#xD;
&#xD;
          -  Active malignant disease or malignant disease within the last 5 years with exception&#xD;
             of fully treated local basal cell carcinoma or carcinoma in situ of cervix&#xD;
&#xD;
          -  Proliferative retinopathy judged by retina-photo within the last year - only with&#xD;
             concomitant diabetes&#xD;
&#xD;
          -  Heart insufficiency, New York Heart Association (NYHA) class above 2&#xD;
&#xD;
          -  Adults with GHD with poorly controlled diabetes mellitus with a glycosylated&#xD;
             haemoglobin (HbA1c) 64 mmol/mol (8.0%) and/or insulin treatment&#xD;
&#xD;
          -  Stable pituitary replacement therapy for less than 3 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Global Clinical Registry (GCR,1452)</last_name>
    <role>Study Director</role>
    <affiliation>Novo Nordisk A/S</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>København Ø</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Odense</city>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Århus C</city>
        <zip>8000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Stockholm</city>
        <zip>141 86</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
    <country>Sweden</country>
  </location_countries>
  <link>
    <url>http://novonordisk-trials.com</url>
    <description>Clinical Trials at Novo Nordisk</description>
  </link>
  <reference>
    <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.</citation>
    <PMID>33313798</PMID>
  </reference>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>October 11, 2012</study_first_submitted>
  <study_first_submitted_qc>October 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <last_update_submitted>December 22, 2020</last_update_submitted>
  <last_update_submitted_qc>December 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dwarfism, Pituitary</mesh_term>
    <mesh_term>Endocrine System Diseases</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01706783
org study id: NN8640-3947
secondary id: 2011-005484-24
secondary id: U1111-1125-7331
nct id: NCT01706783
lead sponsor: 
has dmc: No
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).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of adverse events (AEs)
time frame: From first administration of trial product and up until Day 49
measure: NNC0195-0092 (somapacitan) only: Area under the curve, AUC (0-168h)
time frame: From 0 to 168 hours
measure: Norditropin NordiFlex® only: AUC (0-24h)
time frame: From 0 to 24 hours
measure: NNC0195-0092 (somapacitan), first dose administration only: AUC (0-168h)
time frame: From 0 to 168 hours
measure: Norditropin NordiFlex®, first dose administration only: AUC (0-24h)
time frame: From 0 to 24 hours
measure: NNC0195-0092 (somapacitan): Maximum serum concentration (Cmax)
time frame: From 0 to 168 hours
measure: Norditropin NordiFlex®: Cmax
time frame: From 0 to 24 hours
measure: Insulin-like growth factor I (IGF-I): AUC (0-168h)
time frame: From 0 to 168 hours
measure: IGF-I: Cmax
time frame: From 0 to 168 hours
measure: Insulin-like growth factor binding protein-3 (IGFBP-3): AUC IGFBP-3(0-168h)
time frame: From 0 to 168 hours
measure: IGFBP-3: Cmax
time frame: From 0 to 168 hours
arm group label: NNC0195-0092 (somapacitan)
arm group type: Experimental
arm group label: Norditropin NordiFlex®
arm group type: Active Comparator
intervention type: Drug
intervention name: somapacitan
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
arm group label: NNC0195-0092 (somapacitan)
other name: NNC0195-0092
intervention type: Drug
intervention name: Norditropin NordiFlex®
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
arm group label: Norditropin NordiFlex®
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: No
last name: Global Clinical Registry (GCR,1452)
role: Study Director
affiliation: Novo Nordisk A/S
facility: 
facility: 
facility: 
facility: 
country: Denmark
country: Sweden
url: http://novonordisk-trials.com
description: Clinical Trials at Novo Nordisk
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.
PMID: 33313798
responsible party type: Sponsor
mesh term: Dwarfism, Pituitary
mesh term: Endocrine System Diseases