<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/NCT03811535</url>
  </required_header>
  <id_info>
    <org_study_id>NN8640-4263</org_study_id>
    <secondary_id>U1111-1207-9691</secondary_id>
    <secondary_id>2018-000231-27</secondary_id>
    <secondary_id>JapicCTI-194773</secondary_id>
    <nct_id>NCT03811535</nct_id>
  </id_info>
  <brief_title>A Research Study in Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day (REAL4)</brief_title>
  <acronym>REAL4</acronym>
  <official_title>A Trial Comparing the Effect and Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® in Children 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>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study compares 2 medicines for children who do not have enough hormone to grow:&#xD;
      somapacitan given once a week (a new medicine) and Norditropin® given once a day (the&#xD;
      medicine doctors can already prescribe). Researchers will test to see how well somapacitan&#xD;
      works. The study will also test if somapacitan is safe. Participants will either get&#xD;
      somapacitan or Norditropin® - which treatment participants get, is decided by chance. Both&#xD;
      participants and the study doctor will know which treatment participants get. The study will&#xD;
      last for 4 years. Participants will attend 19 clinic visits and have 1 phone call with the&#xD;
      study doctor.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">May 20, 2019</start_date>
  <completion_date type="Anticipated">September 30, 2025</completion_date>
  <primary_completion_date type="Actual">November 10, 2021</primary_completion_date>
  <phase>Phase 3</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>
    <intervention_model_description>Participants will receive either somapacitan once weekly or Norditropin® once daily for 52 weeks (main trial period). All participants completing the main trial period will receive somapacitan weekly for 3 years (extension trial period).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Height Velocity: In-trial Observation Period</measure>
    <time_frame>From baseline (week 0) to visit 7 (week 52)</time_frame>
    <description>Height velocity (HV) was derived from height measurements taken at baseline and Week 52 visit as: HV = (height at 52 weeks visit - height at baseline)/(time from baseline to 52 weeks visit in years). Data is reported for 'in-trial' observation period. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Height Velocity: On-treatment Observation Period</measure>
    <time_frame>From baseline (week 0) to visit 7 (week 52)</time_frame>
    <description>Height velocity was derived from height measurements taken at baseline and Week 52 visit as: HV = (height at 52 weeks visit - height at baseline)/(time from baseline to 52 weeks visit in years). Data is reported for 'on-treatment' observation period. On-treatment observation period: from first administration and up until last trial contact, visit 7 or 14 days after last administration, whichever comes first.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Bone Age</measure>
    <time_frame>Baseline (week -2), week 52</time_frame>
    <description>Change from baseline (week -2) in bone age at week 52 is presented. X-ray images of left hand and wrist for bone age assessment according to the Greulich and Pyle atlas were taken. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Height Standard Deviation Score (HSDS)</measure>
    <time_frame>Baseline (week 0), week 52</time_frame>
    <description>Change from baseline (week 0) in HSDS at week 52 is presented. HSDS was derived using Centre for Disease Control and Prevention (CDC) standards. The range for HSDS was -10 to +10. Negative scores indicated a height below the mean height for a child with the same age and gender, whereas positive scores indicated a height above the mean height for a child with the same age and gender. Positive value in change from baseline in HSDS indicated that HSDS was better than baseline HSDS. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Height Velocity Standard Deviation Score (HV SDS)</measure>
    <time_frame>Baseline (week 0), week 52</time_frame>
    <description>Change from baseline (week 0) in HV SDS at week 52 is presented. HV SDS was calculated using the formula: HV SDS = (height velocity - mean)/standard deviation (SD), where height velocity was the height velocity variable measured, mean and SD of height velocity by gender and age for the reference population. The range for HV SDS was -10 to +10. Negative scores indicated a height velocity below the mean height velocity for a child with the same age and gender, whereas positive scores indicated a height velocity above the mean height velocity for a child with the same age and gender. Positive value in change from baseline in HV SDS indicated that HV SDS was better than baseline HV SDS. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fasting Plasma Glucose (FPG) at Week 52</measure>
    <time_frame>Baseline (week -2), week 52</time_frame>
    <description>Change from baseline (week -2) in FPG at week 52 is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in FPG at Week 104</measure>
    <time_frame>Baseline (week -2), week 104</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in FPG at Week 156</measure>
    <time_frame>Baseline (week -2), week 156</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in FPG at Week 208</measure>
    <time_frame>Baseline (week -2), week 208</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Homeostatic Model Assessment Steady State Beta Cell Function (HOMA-B) at Week 52</measure>
    <time_frame>Baseline (week -2), week 52</time_frame>
    <description>Change from baseline (week -2) in HOMA-B at week 52 is presented. HOMA-B is a measure of the beta cell function and was calculated as follows: HOMA-B = (20 * fasting insulin (picomoles per liter [pmol/L]) * 1/6(microunit per milliliter [µU/mL]))/ FPG(mmol/L)-3.5). Negative change from baseline in HOMA-B indicated a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in HOMA-B at Week 104</measure>
    <time_frame>Baseline (week -2), week 104</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in HOMA-B at Week 156</measure>
    <time_frame>Baseline (week -2), week 156</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in HOMA-B at Week 208</measure>
    <time_frame>Baseline (week -2), week 208</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Homeostatic Model Assessment Insulin Resistance (HOMA-IR) at Week 52</measure>
    <time_frame>Baseline (week -2), week 52</time_frame>
    <description>Change from baseline (week -2) in HOMA-IR at week 52 is presented. HOMA-IR is an evaluation of the insulin resistance and was calculated as HOMA-IR = fasting insulin (pmol/L) * 1/6(µU/mL) * FPG(mmol/L) / 22.5. Positive change from baseline in HOMA-IR indicated a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in HOMA-IR at Week 104</measure>
    <time_frame>Baseline (week -2), week 104</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in HOMA-IR at Week 156</measure>
    <time_frame>Baseline (week -2), week 156</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in HOMA-IR at Week 208</measure>
    <time_frame>Baseline (week -2), week 208</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Glycated Haemoglobin (HbA1c) at Week 52</measure>
    <time_frame>Baseline (week -2), week 52</time_frame>
    <description>Change from baseline (week -2) in HbA1c at week 52 is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in HbA1c at Week 104</measure>
    <time_frame>Baseline (week -2), week 104</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in HbA1c at Week 156</measure>
    <time_frame>Baseline (week -2), week 156</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in HbA1c at Week 208</measure>
    <time_frame>Baseline (week -2), week 208</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Insulin-like Growth Factor I (IGF-I) Standard Deviation Score (SDS) at Week 52</measure>
    <time_frame>Baseline (week 0), week 52</time_frame>
    <description>Change from baseline (week 0) in IGF-I SDS at week 52 is presented. The range for IGF-I SDS was from -10 to +10. Negative scores indicated a IGF-I below the mean IGF-I for a child with the same age and gender, whereas positive scores indicated a IGF-I above the mean IGF-I for a child with the same age and gender. For participants with low IGF-I SDS at baseline, a positive change from baseline in IGF-I SDS indicated a better outcome. Data is reported for 'in-trial' observation period. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in IGF-I SDS at Week 104</measure>
    <time_frame>Baseline (week 0), week 104</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in IGF-I SDS at Week 156</measure>
    <time_frame>Baseline (week 0), week 156</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in IGF-I SDS at Week 208</measure>
    <time_frame>Baseline (week 0), week 208</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) Standard Deviation Score (SDS) at Week 52</measure>
    <time_frame>Baseline (week 0), week 52</time_frame>
    <description>Change from baseline (week 0) in IGFBP-3 SDS at week 52 is presented. The range for IGFBP-3 SDS was from -10 to +10. Negative scores indicated a IGFBP-3 below the mean IGFBP-3 for a child with the same age and gender, whereas positive scores indicated a IGFBP-3 above the mean IGFBP-3 for a child with the same age and gender. For participants with low IGFBP-3 SDS at baseline, a positive change from baseline in IGFBP-3 SDS indicated a better outcome. Data is reported for 'in-trial' observation period. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in IGFBP-3 SDS at Week 104</measure>
    <time_frame>Baseline (week 0), week 104</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in IGFBP-3 SDS at Week 156</measure>
    <time_frame>Baseline (week 0), week 156</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in IGFBP-3 SDS at Week 208</measure>
    <time_frame>Baseline (week 0), week 208</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Growth Hormone Deficiency in Children</condition>
  <arm_group>
    <arm_group_label>Somapacitan weekly</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive somapacitan weekly for 52 weeks (main trial period). Participants completing the main trial period in both the treatment arms ('Somapacitan weekly' and 'Norditropin® daily') will receive somapacitan weekly for 3 years (extension trial period).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Norditropin® daily</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive Norditropin® daily for 52 weeks (main trial period).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Somapacitan</intervention_name>
    <description>Somapacitan will be administered subcutaneously (s.c.; under the skin) once weekly by PDS290 pen-injector. Somapacitan can be injected any time during the once weekly dosing day. The dose will be calculated based on the subject's current body weight.</description>
    <arm_group_label>Somapacitan weekly</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Norditropin®</intervention_name>
    <description>Norditropin® will be administered s.c. once daily by FlexPro® pen-injector. Norditropin® should be injected daily in the evening. The dose will be calculated based on the subject's current body weight.</description>
    <arm_group_label>Norditropin® daily</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Prepubertal children: a) Boys: Age more than or equal to 2 years and 26 weeks and less&#xD;
             than 11.0 years at screening. Testis volume less than 4 ml. b) Girls: Age more than or&#xD;
             equal to 2 years and 26 weeks and less than 10.0 years at screening. Tanner stage 1&#xD;
             for breast development (no palpable glandular breast tissue)&#xD;
&#xD;
          -  Confirmed diagnosis of growth hormone deficiency determined by two different growth&#xD;
             hormone stimulation tests performed within 12 months prior to randomisation, defined&#xD;
             as a peak growth hormone level of less than or equal to 10.0 ng/ml using the World&#xD;
             Health Organisation (WHO) International Somatropin 98/574 standard&#xD;
&#xD;
          -  Impaired height defined as at least 2.0 standard deviations below the mean height for&#xD;
             chronological age and gender at screening according to the standards of Center for&#xD;
             Disease Control and Prevention&#xD;
&#xD;
          -  Impaired height velocity, defined as annualised height velocity below the 25th&#xD;
             percentile for chronological age and gender according to the standards of Prader&#xD;
             calculated over a time span of minimum 6 months and maximum 18 months prior to&#xD;
             screening&#xD;
&#xD;
          -  Insulin-like Growth Factor-I (IGF-I) less than -1.0 SDS at screening, compared to age&#xD;
             and gender normalized range measured at central laboratory&#xD;
&#xD;
          -  No prior exposure to growth hormone therapy or IGF-I treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any known or suspected clinically significant abnormality likely to affect growth or&#xD;
             the ability to evaluate growth with standing height measurements&#xD;
&#xD;
          -  Current inflammatory diseases requiring systemic corticosteroid treatment for longer&#xD;
             than 2 consecutive weeks within the last 3 months prior to screening&#xD;
&#xD;
          -  Children requiring inhaled glucocorticoid therapy at a dose of greater than 400 μg/day&#xD;
             of inhaled budesonide or equivalents for longer than 4 consecutive weeks within the&#xD;
             last 12 months prior to screening&#xD;
&#xD;
          -  Diagnosis of attention deficit hyperactivity disorder&#xD;
&#xD;
          -  Concomitant administration of other treatments that may have an effect on growth, e.g.&#xD;
             but not limited to methylphenidate for treatment of attention deficit hyperactivity&#xD;
             disorder&#xD;
&#xD;
          -  Prior history or presence of malignancy including intracranial tumours&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Transparency (dept. 2834)</last_name>
    <role>Study Director</role>
    <affiliation>Novo Nordisk A/S</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95821</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Centennial</city>
        <state>Colorado</state>
        <zip>80112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Greenwood Village</city>
        <state>Colorado</state>
        <zip>80111-2803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Wilmington</city>
        <state>Delaware</state>
        <zip>19803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Aventura</city>
        <state>Florida</state>
        <zip>33180</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30318</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55454</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Saint Paul</city>
        <state>Minnesota</state>
        <zip>55102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89113</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Morristown</city>
        <state>New Jersey</state>
        <zip>07962</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Mineola</city>
        <state>New York</state>
        <zip>11501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78723</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Algiers</city>
        <zip>16000</zip>
        <country>Algeria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Constantine</city>
        <zip>25000</zip>
        <country>Algeria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Graz</city>
        <zip>8036</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Salzburg</city>
        <zip>A 5020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>St. Poelten</city>
        <zip>A 3100</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 2B7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tallinn</city>
        <zip>13419</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tartu</city>
        <zip>50406</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>ANGERS cedex 09</city>
        <zip>49033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Bordeaux Cedex</city>
        <zip>33076</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Le Kremlin-bicetre</city>
        <zip>94275</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>MARSEILLE Cédex 05</city>
        <zip>13385</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Frankfurt am Main</city>
        <zip>60596</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tübingen</city>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Ulm</city>
        <zip>89075</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kochi</city>
        <state>Kerala</state>
        <zip>682041</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Pune</city>
        <state>Maharashtra</state>
        <zip>411001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>New Dehli</city>
        <state>New Delhi</state>
        <zip>110029</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Dublin</city>
        <zip>D12 N512</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Haifa</city>
        <zip>31096</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kfar Saba</city>
        <zip>44281</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Petah Tikva</city>
        <zip>49202</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Zerifin</city>
        <zip>70300</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Firenze</city>
        <zip>50139</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Genova</city>
        <zip>16147</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Roma</city>
        <zip>00165</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Fukuoka-shi, Fukuoka</city>
        <zip>813-0017</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Fukuyama-shi, Hiroshima</city>
        <zip>720-8520</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Fukuyama-shi, Hiroshima</city>
        <zip>721-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kyoto</city>
        <zip>602-8566</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Mito, Ibaraki</city>
        <zip>311-4145</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Nara-shi, Nara</city>
        <zip>630-8581</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Obu-shi, Aichi</city>
        <zip>474-8710</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Okayama-shi, Okayama</city>
        <zip>701-1192</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Osaka</city>
        <zip>534-0021</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Osaka</city>
        <zip>594-1101</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Saitama-shi, Saitama</city>
        <zip>330-8777</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Shizuoka</city>
        <zip>431-3192</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Suita-shi, Osaka</city>
        <zip>565-0871</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>157 8535</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>158-0097</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Busan</city>
        <zip>47392</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Daegu</city>
        <zip>41944</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Gyeonggi-do</city>
        <zip>13620</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Gyeonggi-do</city>
        <zip>16499</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Riga</city>
        <zip>LV1004</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Bergen</city>
        <zip>5021</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Szczecin</city>
        <zip>71-252</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Warszawa</city>
        <zip>04-730</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Izhevsk</city>
        <zip>426009</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Moscow</city>
        <zip>119435</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Moscow</city>
        <zip>125373</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Novosibirsk</city>
        <zip>630048</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Rostov-on-Don</city>
        <zip>344013</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>191144</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Samara</city>
        <zip>443079</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tomsk</city>
        <zip>634050</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Belgrade</city>
        <zip>11000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Belgrade</city>
        <zip>11070</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Novi Sad</city>
        <zip>21000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Ljubljana</city>
        <zip>1525</zip>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Esplugues Llobregat(Barcelona)</city>
        <zip>08950</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Santiago de Compostela</city>
        <zip>15706</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Basel</city>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Zürich</city>
        <zip>8032</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Bangkok</city>
        <zip>10330</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Bangkok</city>
        <zip>10400</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kharkiv</city>
        <zip>61000</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kyiv</city>
        <zip>04114</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Vinnytsia</city>
        <zip>21010</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Cambridge</city>
        <zip>CB2 0QQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Hull</city>
        <zip>HU3 2JZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Liverpool</city>
        <zip>L12 2AP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>London</city>
        <zip>E1 1BB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Manchester</city>
        <zip>M13 9WL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Tooting</city>
        <zip>SW17 0RE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Algeria</country>
    <country>Austria</country>
    <country>Canada</country>
    <country>Estonia</country>
    <country>France</country>
    <country>Germany</country>
    <country>India</country>
    <country>Ireland</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Latvia</country>
    <country>Norway</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>Serbia</country>
    <country>Slovenia</country>
    <country>Spain</country>
    <country>Switzerland</country>
    <country>Thailand</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Denmark</country>
    <country>Hungary</country>
  </removed_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>January 18, 2019</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <results_first_submitted>May 24, 2023</results_first_submitted>
  <results_first_submitted_qc>July 14, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">August 4, 2023</results_first_posted>
  <disposition_first_submitted>October 31, 2022</disposition_first_submitted>
  <disposition_first_submitted_qc>July 14, 2023</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">August 4, 2023</disposition_first_posted>
  <last_update_submitted>August 24, 2023</last_update_submitted>
  <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2023</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>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>According to the Novo Nordisk disclosure commitment on novonordisk-trials.com</ipd_description>
    <ipd_url>https://www.novonordisk-trials.com</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 22, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/35/NCT03811535/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The trial was conducted at 86 sites in 20 countries as follows (number of sites that screened participants/ number of sites that randomized participants): Austria (2/1); Canada (1/1); Denmark (1/0); France (4/4); Germany (3/2); Hungary (1/0); India (3/3); Israel (4/4); Italy (3/2); Japan (17/14); Korea (8/6); Latvia (1/1); Poland (1/1); Russia (8/8); Serbia (5/3); Slovenia (1/1); Spain (2/2); Switzerland (1/1); Thailand (2/2); Ukraine (3/3); United Kingdom (5/5); United States (23/22).</recruitment_details>
      <pre_assignment_details>Data reported based on the main part of the trial i.e. up to week 52.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Norditropin</title>
          <description>Participants received 0.034 milligrams/kilogram (mg/kg) norditropin subcutaneously (s.c.; under the skin) by FlexPro pen-injector once daily for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).</description>
        </group>
        <group group_id="P2">
          <title>Somapacitan</title>
          <description>Participants received 0.16 mg/kg somapacitan s.c. once weekly by PDS290 pen-injector for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="68"/>
                <participants group_id="P2" count="132"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="68"/>
                <participants group_id="P2" count="132"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Full analysis set included all randomized participants.</population>
      <group_list>
        <group group_id="B1">
          <title>Norditropin</title>
          <description>Participants received 0.034 milligrams/kilogram (mg/kg) norditropin subcutaneously (s.c.; under the skin) by FlexPro pen-injector once daily for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).</description>
        </group>
        <group group_id="B2">
          <title>Somapacitan</title>
          <description>Participants received 0.16 mg/kg somapacitan s.c. once weekly by PDS290 pen-injector for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="68"/>
            <count group_id="B2" value="132"/>
            <count group_id="B3" value="200"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.43" spread="2.42"/>
                    <measurement group_id="B2" value="6.38" spread="2.23"/>
                    <measurement group_id="B3" value="6.40" spread="2.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="51"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="99"/>
                    <measurement group_id="B3" value="149"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="63"/>
                    <measurement group_id="B2" value="119"/>
                    <measurement group_id="B3" value="182"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Race</title>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="78"/>
                    <measurement group_id="B3" value="114"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="74"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Height Velocity: In-trial Observation Period</title>
        <description>Height velocity (HV) was derived from height measurements taken at baseline and Week 52 visit as: HV = (height at 52 weeks visit - height at baseline)/(time from baseline to 52 weeks visit in years). Data is reported for 'in-trial' observation period. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.</description>
        <time_frame>From baseline (week 0) to visit 7 (week 52)</time_frame>
        <population>Full analysis set included all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Norditropin</title>
            <description>Participants received 0.034 milligrams/kilogram (mg/kg) norditropin subcutaneously (s.c.; under the skin) by FlexPro pen-injector once daily for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).</description>
          </group>
          <group group_id="O2">
            <title>Somapacitan</title>
            <description>Participants received 0.16 mg/kg somapacitan s.c. once weekly by PDS290 pen-injector for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).</description>
          </group>
        </group_list>
        <measure>
          <title>Height Velocity: In-trial Observation Period</title>
          <description>Height velocity (HV) was derived from height measurements taken at baseline and Week 52 visit as: HV = (height at 52 weeks visit - height at baseline)/(time from baseline to 52 weeks visit in years). Data is reported for 'in-trial' observation period. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.</description>
          <population>Full analysis set included all randomized participants.</population>
          <units>centimeters per year (cm/year)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
                <count group_id="O2" value="132"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.8" spread="2.9"/>
                    <measurement group_id="O2" value="11.2" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Height velocity at week 52 was analyzed using an analysis of covariance model with treatment, gender, age group, region, growth hormone (GH) peak group and gender by age group by region interaction term as factors, and baseline height as covariate.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The pre-specified non-inferiority margin was -1.8 cm/year.</non_inferiority_desc>
            <param_type>Treatment difference</param_type>
            <param_value>-0.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.1</ci_lower_limit>
            <ci_upper_limit>0.2</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Height Velocity: On-treatment Observation Period</title>
        <description>Height velocity was derived from height measurements taken at baseline and Week 52 visit as: HV = (height at 52 weeks visit - height at baseline)/(time from baseline to 52 weeks visit in years). Data is reported for 'on-treatment' observation period. On-treatment observation period: from first administration and up until last trial contact, visit 7 or 14 days after last administration, whichever comes first.</description>
        <time_frame>From baseline (week 0) to visit 7 (week 52)</time_frame>
        <population>Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Norditropin</title>
            <description>Participants received 0.034 milligrams/kilogram (mg/kg) norditropin subcutaneously (s.c.; under the skin) by FlexPro pen-injector once daily for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).</description>
          </group>
          <group group_id="O2">
            <title>Somapacitan</title>
            <description>Participants received 0.16 mg/kg somapacitan s.c. once weekly by PDS290 pen-injector for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).</description>
          </group>
        </group_list>
        <measure>
          <title>Height Velocity: On-treatment Observation Period</title>
          <description>Height velocity was derived from height measurements taken at baseline and Week 52 visit as: HV = (height at 52 weeks visit - height at baseline)/(time from baseline to 52 weeks visit in years). Data is reported for 'on-treatment' observation period. On-treatment observation period: from first administration and up until last trial contact, visit 7 or 14 days after last administration, whichever comes first.</description>
          <population>Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data.</population>
          <units>cm/year</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
                <count group_id="O2" value="131"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.8" spread="2.9"/>
                    <measurement group_id="O2" value="11.2" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Height velocity at 52 weeks was analyzed using a mixed model for repeated measurements, with treatment, gender, age group, region, GH peak group and gender by age group by region interaction terms as factors and baseline height as a covariate, all nested within week as a factor.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The pre-specified non-inferiority margin was -1.8 cm/year.</non_inferiority_desc>
            <param_type>Treatment difference</param_type>
            <param_value>-0.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.1</ci_lower_limit>
            <ci_upper_limit>0.2</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Bone Age</title>
        <description>Change from baseline (week -2) in bone age at week 52 is presented. X-ray images of left hand and wrist for bone age assessment according to the Greulich and Pyle atlas were taken. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.</description>
        <time_frame>Baseline (week -2), week 52</time_frame>
        <population>Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Norditropin</title>
            <description>Participants received 0.034 milligrams/kilogram (mg/kg) norditropin subcutaneously (s.c.; under the skin) by FlexPro pen-injector once daily for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).</description>
          </group>
          <group group_id="O2">
            <title>Somapacitan</title>
            <description>Participants received 0.16 mg/kg somapacitan s.c. once weekly by PDS290 pen-injector for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Bone Age</title>
          <description>Change from baseline (week -2) in bone age at week 52 is presented. X-ray images of left hand and wrist for bone age assessment according to the Greulich and Pyle atlas were taken. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.</description>
          <population>Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data.</population>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
                <count group_id="O2" value="131"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.28" spread="0.76"/>
                    <measurement group_id="O2" value="1.13" spread="0.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Height Standard Deviation Score (HSDS)</title>
        <description>Change from baseline (week 0) in HSDS at week 52 is presented. HSDS was derived using Centre for Disease Control and Prevention (CDC) standards. The range for HSDS was -10 to +10. Negative scores indicated a height below the mean height for a child with the same age and gender, whereas positive scores indicated a height above the mean height for a child with the same age and gender. Positive value in change from baseline in HSDS indicated that HSDS was better than baseline HSDS. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.</description>
        <time_frame>Baseline (week 0), week 52</time_frame>
        <population>Full analysis set included all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Norditropin</title>
            <description>Participants received 0.034 milligrams/kilogram (mg/kg) norditropin subcutaneously (s.c.; under the skin) by FlexPro pen-injector once daily for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).</description>
          </group>
          <group group_id="O2">
            <title>Somapacitan</title>
            <description>Participants received 0.16 mg/kg somapacitan s.c. once weekly by PDS290 pen-injector for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Height Standard Deviation Score (HSDS)</title>
          <description>Change from baseline (week 0) in HSDS at week 52 is presented. HSDS was derived using Centre for Disease Control and Prevention (CDC) standards. The range for HSDS was -10 to +10. Negative scores indicated a height below the mean height for a child with the same age and gender, whereas positive scores indicated a height above the mean height for a child with the same age and gender. Positive value in change from baseline in HSDS indicated that HSDS was better than baseline HSDS. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.</description>
          <population>Full analysis set included all randomized participants.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
                <count group_id="O2" value="132"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.37" spread="0.69"/>
                    <measurement group_id="O2" value="1.21" spread="0.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Height Velocity Standard Deviation Score (HV SDS)</title>
        <description>Change from baseline (week 0) in HV SDS at week 52 is presented. HV SDS was calculated using the formula: HV SDS = (height velocity - mean)/standard deviation (SD), where height velocity was the height velocity variable measured, mean and SD of height velocity by gender and age for the reference population. The range for HV SDS was -10 to +10. Negative scores indicated a height velocity below the mean height velocity for a child with the same age and gender, whereas positive scores indicated a height velocity above the mean height velocity for a child with the same age and gender. Positive value in change from baseline in HV SDS indicated that HV SDS was better than baseline HV SDS. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.</description>
        <time_frame>Baseline (week 0), week 52</time_frame>
        <population>Full analysis set included all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Norditropin</title>
            <description>Participants received 0.034 milligrams/kilogram (mg/kg) norditropin subcutaneously (s.c.; under the skin) by FlexPro pen-injector once daily for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).</description>
          </group>
          <group group_id="O2">
            <title>Somapacitan</title>
            <description>Participants received 0.16 mg/kg somapacitan s.c. once weekly by PDS290 pen-injector for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Height Velocity Standard Deviation Score (HV SDS)</title>
          <description>Change from baseline (week 0) in HV SDS at week 52 is presented. HV SDS was calculated using the formula: HV SDS = (height velocity - mean)/standard deviation (SD), where height velocity was the height velocity variable measured, mean and SD of height velocity by gender and age for the reference population. The range for HV SDS was -10 to +10. Negative scores indicated a height velocity below the mean height velocity for a child with the same age and gender, whereas positive scores indicated a height velocity above the mean height velocity for a child with the same age and gender. Positive value in change from baseline in HV SDS indicated that HV SDS was better than baseline HV SDS. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.</description>
          <population>Full analysis set included all randomized participants.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
                <count group_id="O2" value="132"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.97" spread="4.38"/>
                    <measurement group_id="O2" value="7.97" spread="3.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Fasting Plasma Glucose (FPG) at Week 52</title>
        <description>Change from baseline (week -2) in FPG at week 52 is presented.</description>
        <time_frame>Baseline (week -2), week 52</time_frame>
        <population>Safety analysis set included all randomized participants exposed to at least one dose of randomized treatment. Overall Number of Participants Analyzed = participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Norditropin</title>
            <description>Participants received 0.034 milligrams/kilogram (mg/kg) norditropin subcutaneously (s.c.; under the skin) by FlexPro pen-injector once daily for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).</description>
          </group>
          <group group_id="O2">
            <title>Somapacitan</title>
            <description>Participants received 0.16 mg/kg somapacitan s.c. once weekly by PDS290 pen-injector for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Fasting Plasma Glucose (FPG) at Week 52</title>
          <description>Change from baseline (week -2) in FPG at week 52 is presented.</description>
          <population>Safety analysis set included all randomized participants exposed to at least one dose of randomized treatment. Overall Number of Participants Analyzed = participants with available data.</population>
          <units>Millimoles per liter (mmol/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="66"/>
                <count group_id="O2" value="124"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.255" spread="0.790"/>
                    <measurement group_id="O2" value="0.083" spread="0.567"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in FPG at Week 104</title>
        <time_frame>Baseline (week -2), week 104</time_frame>
        <posting_date>12/2025</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in FPG at Week 156</title>
        <time_frame>Baseline (week -2), week 156</time_frame>
        <posting_date>12/2025</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in FPG at Week 208</title>
        <time_frame>Baseline (week -2), week 208</time_frame>
        <posting_date>12/2025</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Homeostatic Model Assessment Steady State Beta Cell Function (HOMA-B) at Week 52</title>
        <description>Change from baseline (week -2) in HOMA-B at week 52 is presented. HOMA-B is a measure of the beta cell function and was calculated as follows: HOMA-B = (20 * fasting insulin (picomoles per liter [pmol/L]) * 1/6(microunit per milliliter [µU/mL]))/ FPG(mmol/L)-3.5). Negative change from baseline in HOMA-B indicated a worse outcome.</description>
        <time_frame>Baseline (week -2), week 52</time_frame>
        <population>Safety analysis set included all randomized participants exposed to at least one dose of randomized treatment. Overall Number of Participants Analyzed = participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Norditropin</title>
            <description>Participants received 0.034 milligrams/kilogram (mg/kg) norditropin subcutaneously (s.c.; under the skin) by FlexPro pen-injector once daily for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).</description>
          </group>
          <group group_id="O2">
            <title>Somapacitan</title>
            <description>Participants received 0.16 mg/kg somapacitan s.c. once weekly by PDS290 pen-injector for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Homeostatic Model Assessment Steady State Beta Cell Function (HOMA-B) at Week 52</title>
          <description>Change from baseline (week -2) in HOMA-B at week 52 is presented. HOMA-B is a measure of the beta cell function and was calculated as follows: HOMA-B = (20 * fasting insulin (picomoles per liter [pmol/L]) * 1/6(microunit per milliliter [µU/mL]))/ FPG(mmol/L)-3.5). Negative change from baseline in HOMA-B indicated a worse outcome.</description>
          <population>Safety analysis set included all randomized participants exposed to at least one dose of randomized treatment. Overall Number of Participants Analyzed = participants with available data.</population>
          <units>Percentage of HOMA-B</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
                <count group_id="O2" value="111"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.24" spread="81.59"/>
                    <measurement group_id="O2" value="37.71" spread="59.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in HOMA-B at Week 104</title>
        <time_frame>Baseline (week -2), week 104</time_frame>
        <posting_date>12/2025</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in HOMA-B at Week 156</title>
        <time_frame>Baseline (week -2), week 156</time_frame>
        <posting_date>12/2025</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in HOMA-B at Week 208</title>
        <time_frame>Baseline (week -2), week 208</time_frame>
        <posting_date>12/2025</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Homeostatic Model Assessment Insulin Resistance (HOMA-IR) at Week 52</title>
        <description>Change from baseline (week -2) in HOMA-IR at week 52 is presented. HOMA-IR is an evaluation of the insulin resistance and was calculated as HOMA-IR = fasting insulin (pmol/L) * 1/6(µU/mL) * FPG(mmol/L) / 22.5. Positive change from baseline in HOMA-IR indicated a worse outcome.</description>
        <time_frame>Baseline (week -2), week 52</time_frame>
        <population>Safety analysis set included all randomized participants exposed to at least one dose of randomized treatment. Overall Number of Participants Analyzed = participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Norditropin</title>
            <description>Participants received 0.034 milligrams/kilogram (mg/kg) norditropin subcutaneously (s.c.; under the skin) by FlexPro pen-injector once daily for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).</description>
          </group>
          <group group_id="O2">
            <title>Somapacitan</title>
            <description>Participants received 0.16 mg/kg somapacitan s.c. once weekly by PDS290 pen-injector for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Homeostatic Model Assessment Insulin Resistance (HOMA-IR) at Week 52</title>
          <description>Change from baseline (week -2) in HOMA-IR at week 52 is presented. HOMA-IR is an evaluation of the insulin resistance and was calculated as HOMA-IR = fasting insulin (pmol/L) * 1/6(µU/mL) * FPG(mmol/L) / 22.5. Positive change from baseline in HOMA-IR indicated a worse outcome.</description>
          <population>Safety analysis set included all randomized participants exposed to at least one dose of randomized treatment. Overall Number of Participants Analyzed = participants with available data.</population>
          <units>Percentage of HOMA-IR</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="114"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.03" spread="1.12"/>
                    <measurement group_id="O2" value="0.60" spread="1.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in HOMA-IR at Week 104</title>
        <time_frame>Baseline (week -2), week 104</time_frame>
        <posting_date>12/2025</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in HOMA-IR at Week 156</title>
        <time_frame>Baseline (week -2), week 156</time_frame>
        <posting_date>12/2025</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in HOMA-IR at Week 208</title>
        <time_frame>Baseline (week -2), week 208</time_frame>
        <posting_date>12/2025</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Glycated Haemoglobin (HbA1c) at Week 52</title>
        <description>Change from baseline (week -2) in HbA1c at week 52 is presented.</description>
        <time_frame>Baseline (week -2), week 52</time_frame>
        <population>Safety analysis set included all randomized participants exposed to at least one dose of randomized treatment. Overall Number of Participants Analyzed = participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Norditropin</title>
            <description>Participants received 0.034 milligrams/kilogram (mg/kg) norditropin subcutaneously (s.c.; under the skin) by FlexPro pen-injector once daily for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).</description>
          </group>
          <group group_id="O2">
            <title>Somapacitan</title>
            <description>Participants received 0.16 mg/kg somapacitan s.c. once weekly by PDS290 pen-injector for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Glycated Haemoglobin (HbA1c) at Week 52</title>
          <description>Change from baseline (week -2) in HbA1c at week 52 is presented.</description>
          <population>Safety analysis set included all randomized participants exposed to at least one dose of randomized treatment. Overall Number of Participants Analyzed = participants with available data.</population>
          <units>Percentage of HbA1c</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
                <count group_id="O2" value="130"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.11" spread="0.26"/>
                    <measurement group_id="O2" value="0.09" spread="0.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in HbA1c at Week 104</title>
        <time_frame>Baseline (week -2), week 104</time_frame>
        <posting_date>12/2025</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in HbA1c at Week 156</title>
        <time_frame>Baseline (week -2), week 156</time_frame>
        <posting_date>12/2025</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in HbA1c at Week 208</title>
        <time_frame>Baseline (week -2), week 208</time_frame>
        <posting_date>12/2025</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Insulin-like Growth Factor I (IGF-I) Standard Deviation Score (SDS) at Week 52</title>
        <description>Change from baseline (week 0) in IGF-I SDS at week 52 is presented. The range for IGF-I SDS was from -10 to +10. Negative scores indicated a IGF-I below the mean IGF-I for a child with the same age and gender, whereas positive scores indicated a IGF-I above the mean IGF-I for a child with the same age and gender. For participants with low IGF-I SDS at baseline, a positive change from baseline in IGF-I SDS indicated a better outcome. Data is reported for 'in-trial' observation period. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.</description>
        <time_frame>Baseline (week 0), week 52</time_frame>
        <population>Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Norditropin</title>
            <description>Participants received 0.034 milligrams/kilogram (mg/kg) norditropin subcutaneously (s.c.; under the skin) by FlexPro pen-injector once daily for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).</description>
          </group>
          <group group_id="O2">
            <title>Somapacitan</title>
            <description>Participants received 0.16 mg/kg somapacitan s.c. once weekly by PDS290 pen-injector for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Insulin-like Growth Factor I (IGF-I) Standard Deviation Score (SDS) at Week 52</title>
          <description>Change from baseline (week 0) in IGF-I SDS at week 52 is presented. The range for IGF-I SDS was from -10 to +10. Negative scores indicated a IGF-I below the mean IGF-I for a child with the same age and gender, whereas positive scores indicated a IGF-I above the mean IGF-I for a child with the same age and gender. For participants with low IGF-I SDS at baseline, a positive change from baseline in IGF-I SDS indicated a better outcome. Data is reported for 'in-trial' observation period. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.</description>
          <population>Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="132"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.41" spread="1.09"/>
                    <measurement group_id="O2" value="2.32" spread="1.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in IGF-I SDS at Week 104</title>
        <time_frame>Baseline (week 0), week 104</time_frame>
        <posting_date>12/2025</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in IGF-I SDS at Week 156</title>
        <time_frame>Baseline (week 0), week 156</time_frame>
        <posting_date>12/2025</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in IGF-I SDS at Week 208</title>
        <time_frame>Baseline (week 0), week 208</time_frame>
        <posting_date>12/2025</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) Standard Deviation Score (SDS) at Week 52</title>
        <description>Change from baseline (week 0) in IGFBP-3 SDS at week 52 is presented. The range for IGFBP-3 SDS was from -10 to +10. Negative scores indicated a IGFBP-3 below the mean IGFBP-3 for a child with the same age and gender, whereas positive scores indicated a IGFBP-3 above the mean IGFBP-3 for a child with the same age and gender. For participants with low IGFBP-3 SDS at baseline, a positive change from baseline in IGFBP-3 SDS indicated a better outcome. Data is reported for 'in-trial' observation period. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.</description>
        <time_frame>Baseline (week 0), week 52</time_frame>
        <population>Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Norditropin</title>
            <description>Participants received 0.034 milligrams/kilogram (mg/kg) norditropin subcutaneously (s.c.; under the skin) by FlexPro pen-injector once daily for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).</description>
          </group>
          <group group_id="O2">
            <title>Somapacitan</title>
            <description>Participants received 0.16 mg/kg somapacitan s.c. once weekly by PDS290 pen-injector for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) Standard Deviation Score (SDS) at Week 52</title>
          <description>Change from baseline (week 0) in IGFBP-3 SDS at week 52 is presented. The range for IGFBP-3 SDS was from -10 to +10. Negative scores indicated a IGFBP-3 below the mean IGFBP-3 for a child with the same age and gender, whereas positive scores indicated a IGFBP-3 above the mean IGFBP-3 for a child with the same age and gender. For participants with low IGFBP-3 SDS at baseline, a positive change from baseline in IGFBP-3 SDS indicated a better outcome. Data is reported for 'in-trial' observation period. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.</description>
          <population>Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="132"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.68" spread="1.02"/>
                    <measurement group_id="O2" value="1.58" spread="0.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in IGFBP-3 SDS at Week 104</title>
        <time_frame>Baseline (week 0), week 104</time_frame>
        <posting_date>12/2025</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in IGFBP-3 SDS at Week 156</title>
        <time_frame>Baseline (week 0), week 156</time_frame>
        <posting_date>12/2025</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in IGFBP-3 SDS at Week 208</title>
        <time_frame>Baseline (week 0), week 208</time_frame>
        <posting_date>12/2025</posting_date>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From week -2 up to week 52</time_frame>
      <desc>Safety analysis set included all randomized participants exposed to at least one dose of randomized treatment.</desc>
      <group_list>
        <group group_id="E1">
          <title>Norditropin</title>
          <description>Participants received 0.034 milligrams/kilogram (mg/kg) norditropin subcutaneously (s.c.; under the skin) by FlexPro pen-injector once daily for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).</description>
        </group>
        <group group_id="E2">
          <title>Somapacitan</title>
          <description>Participants received 0.16 mg/kg somapacitan s.c. once weekly by PDS290 pen-injector for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 24</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="132"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="132"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Cryptorchism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="132"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Adrenocortical insufficiency acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="132"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Umbilical hernia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="132"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="132"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>COVID-19</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="132"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="132"/>
              </event>
              <event>
                <sub_title>Otitis media</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="132"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="132"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="132"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Adenoidal hypertrophy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="132"/>
              </event>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="132"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 24</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="46" subjects_at_risk="132"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="6" subjects_affected="4" subjects_at_risk="68"/>
                <counts group_id="E2" events="10" subjects_affected="6" subjects_at_risk="132"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="12" subjects_affected="7" subjects_at_risk="68"/>
                <counts group_id="E2" events="14" subjects_affected="10" subjects_at_risk="132"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="68"/>
                <counts group_id="E2" events="6" subjects_affected="4" subjects_at_risk="132"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="13" subjects_affected="7" subjects_at_risk="68"/>
                <counts group_id="E2" events="22" subjects_affected="15" subjects_at_risk="132"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E2" events="17" subjects_affected="12" subjects_at_risk="132"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="11" subjects_affected="6" subjects_at_risk="68"/>
                <counts group_id="E2" events="22" subjects_affected="16" subjects_at_risk="132"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Reporting Office (2834)</name_or_title>
      <organization>Novo Nordisk A/S</organization>
      <phone>(+1) 866-867-7178</phone>
      <email>clinicaltrials@novonordisk.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03811535
org study id: NN8640-4263
secondary id: U1111-1207-9691
secondary id: 2018-000231-27
secondary id: JapicCTI-194773
nct id: NCT03811535
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The study compares 2 medicines for children who do not have enough hormone to grow:
      somapacitan given once a week (a new medicine) and Norditropin® given once a day (the
      medicine doctors can already prescribe). Researchers will test to see how well somapacitan
      works. The study will also test if somapacitan is safe. Participants will either get
      somapacitan or Norditropin® - which treatment participants get, is decided by chance. Both
      participants and the study doctor will know which treatment participants get. The study will
      last for 4 years. Participants will attend 19 clinic visits and have 1 phone call with the
      study doctor.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants will receive either somapacitan once weekly or Norditropin® once daily for 52 weeks (main trial period). All participants completing the main trial period will receive somapacitan weekly for 3 years (extension trial period).
primary purpose: Treatment
masking: None (Open Label)
measure: Height Velocity: In-trial Observation Period
time frame: From baseline (week 0) to visit 7 (week 52)
description: Height velocity (HV) was derived from height measurements taken at baseline and Week 52 visit as: HV = (height at 52 weeks visit - height at baseline)/(time from baseline to 52 weeks visit in years). Data is reported for 'in-trial' observation period. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.
measure: Height Velocity: On-treatment Observation Period
time frame: From baseline (week 0) to visit 7 (week 52)
description: Height velocity was derived from height measurements taken at baseline and Week 52 visit as: HV = (height at 52 weeks visit - height at baseline)/(time from baseline to 52 weeks visit in years). Data is reported for 'on-treatment' observation period. On-treatment observation period: from first administration and up until last trial contact, visit 7 or 14 days after last administration, whichever comes first.
measure: Change in Bone Age
time frame: Baseline (week -2), week 52
description: Change from baseline (week -2) in bone age at week 52 is presented. X-ray images of left hand and wrist for bone age assessment according to the Greulich and Pyle atlas were taken. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.
measure: Change in Height Standard Deviation Score (HSDS)
time frame: Baseline (week 0), week 52
description: Change from baseline (week 0) in HSDS at week 52 is presented. HSDS was derived using Centre for Disease Control and Prevention (CDC) standards. The range for HSDS was -10 to +10. Negative scores indicated a height below the mean height for a child with the same age and gender, whereas positive scores indicated a height above the mean height for a child with the same age and gender. Positive value in change from baseline in HSDS indicated that HSDS was better than baseline HSDS. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.
measure: Change in Height Velocity Standard Deviation Score (HV SDS)
time frame: Baseline (week 0), week 52
description: Change from baseline (week 0) in HV SDS at week 52 is presented. HV SDS was calculated using the formula: HV SDS = (height velocity - mean)/standard deviation (SD), where height velocity was the height velocity variable measured, mean and SD of height velocity by gender and age for the reference population. The range for HV SDS was -10 to +10. Negative scores indicated a height velocity below the mean height velocity for a child with the same age and gender, whereas positive scores indicated a height velocity above the mean height velocity for a child with the same age and gender. Positive value in change from baseline in HV SDS indicated that HV SDS was better than baseline HV SDS. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.
measure: Change in Fasting Plasma Glucose (FPG) at Week 52
time frame: Baseline (week -2), week 52
description: Change from baseline (week -2) in FPG at week 52 is presented.
measure: Change in FPG at Week 104
time frame: Baseline (week -2), week 104
measure: Change in FPG at Week 156
time frame: Baseline (week -2), week 156
measure: Change in FPG at Week 208
time frame: Baseline (week -2), week 208
measure: Change in Homeostatic Model Assessment Steady State Beta Cell Function (HOMA-B) at Week 52
time frame: Baseline (week -2), week 52
description: Change from baseline (week -2) in HOMA-B at week 52 is presented. HOMA-B is a measure of the beta cell function and was calculated as follows: HOMA-B = (20 * fasting insulin (picomoles per liter [pmol/L]) * 1/6(microunit per milliliter [µU/mL]))/ FPG(mmol/L)-3.5). Negative change from baseline in HOMA-B indicated a worse outcome.
measure: Change in HOMA-B at Week 104
time frame: Baseline (week -2), week 104
measure: Change in HOMA-B at Week 156
time frame: Baseline (week -2), week 156
measure: Change in HOMA-B at Week 208
time frame: Baseline (week -2), week 208
measure: Change in Homeostatic Model Assessment Insulin Resistance (HOMA-IR) at Week 52
time frame: Baseline (week -2), week 52
description: Change from baseline (week -2) in HOMA-IR at week 52 is presented. HOMA-IR is an evaluation of the insulin resistance and was calculated as HOMA-IR = fasting insulin (pmol/L) * 1/6(µU/mL) * FPG(mmol/L) / 22.5. Positive change from baseline in HOMA-IR indicated a worse outcome.
measure: Change in HOMA-IR at Week 104
time frame: Baseline (week -2), week 104
measure: Change in HOMA-IR at Week 156
time frame: Baseline (week -2), week 156
measure: Change in HOMA-IR at Week 208
time frame: Baseline (week -2), week 208
measure: Change in Glycated Haemoglobin (HbA1c) at Week 52
time frame: Baseline (week -2), week 52
description: Change from baseline (week -2) in HbA1c at week 52 is presented.
measure: Change in HbA1c at Week 104
time frame: Baseline (week -2), week 104
measure: Change in HbA1c at Week 156
time frame: Baseline (week -2), week 156
measure: Change in HbA1c at Week 208
time frame: Baseline (week -2), week 208
measure: Change in Insulin-like Growth Factor I (IGF-I) Standard Deviation Score (SDS) at Week 52
time frame: Baseline (week 0), week 52
description: Change from baseline (week 0) in IGF-I SDS at week 52 is presented. The range for IGF-I SDS was from -10 to +10. Negative scores indicated a IGF-I below the mean IGF-I for a child with the same age and gender, whereas positive scores indicated a IGF-I above the mean IGF-I for a child with the same age and gender. For participants with low IGF-I SDS at baseline, a positive change from baseline in IGF-I SDS indicated a better outcome. Data is reported for 'in-trial' observation period. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.
measure: Change in IGF-I SDS at Week 104
time frame: Baseline (week 0), week 104
measure: Change in IGF-I SDS at Week 156
time frame: Baseline (week 0), week 156
measure: Change in IGF-I SDS at Week 208
time frame: Baseline (week 0), week 208
measure: Change in Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) Standard Deviation Score (SDS) at Week 52
time frame: Baseline (week 0), week 52
description: Change from baseline (week 0) in IGFBP-3 SDS at week 52 is presented. The range for IGFBP-3 SDS was from -10 to +10. Negative scores indicated a IGFBP-3 below the mean IGFBP-3 for a child with the same age and gender, whereas positive scores indicated a IGFBP-3 above the mean IGFBP-3 for a child with the same age and gender. For participants with low IGFBP-3 SDS at baseline, a positive change from baseline in IGFBP-3 SDS indicated a better outcome. Data is reported for 'in-trial' observation period. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.
measure: Change in IGFBP-3 SDS at Week 104
time frame: Baseline (week 0), week 104
measure: Change in IGFBP-3 SDS at Week 156
time frame: Baseline (week 0), week 156
measure: Change in IGFBP-3 SDS at Week 208
time frame: Baseline (week 0), week 208
arm group label: Somapacitan weekly
arm group type: Experimental
description: Participants will receive somapacitan weekly for 52 weeks (main trial period). Participants completing the main trial period in both the treatment arms ('Somapacitan weekly' and 'Norditropin® daily') will receive somapacitan weekly for 3 years (extension trial period).
arm group label: Norditropin® daily
arm group type: Active Comparator
description: Participants will receive Norditropin® daily for 52 weeks (main trial period).
intervention type: Drug
intervention name: Somapacitan
description: Somapacitan will be administered subcutaneously (s.c.; under the skin) once weekly by PDS290 pen-injector. Somapacitan can be injected any time during the once weekly dosing day. The dose will be calculated based on the subject's current body weight.
arm group label: Somapacitan weekly
intervention type: Drug
intervention name: Norditropin®
description: Norditropin® will be administered s.c. once daily by FlexPro® pen-injector. Norditropin® should be injected daily in the evening. The dose will be calculated based on the subject's current body weight.
arm group label: Norditropin® daily
criteria: 
gender: All
minimum age: N/A
maximum age: 11 Years
healthy volunteers: No
last name: Clinical Transparency (dept. 2834)
role: Study Director
affiliation: Novo Nordisk A/S
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country: Algeria
country: Austria
country: Canada
country: Estonia
country: France
country: Germany
country: India
country: Ireland
country: Israel
country: Italy
country: Japan
country: Korea, Republic of
country: Latvia
country: Norway
country: Poland
country: Russian Federation
country: Serbia
country: Slovenia
country: Spain
country: Switzerland
country: Thailand
country: Ukraine
country: United Kingdom
country: United States
country: Denmark
country: Hungary
responsible party type: Sponsor
mesh term: Dwarfism, Pituitary
sharing ipd: Yes
ipd description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
ipd url: https://www.novonordisk-trials.com
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 