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CTRI Number  CTRI/2020/08/027258 [Registered on: 20/08/2020] Trial Registered Prospectively
Last Modified On: 26/02/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A Research Study in Children Born Small and Who Stayed Small. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day 
Scientific Title of Study   A Dose-finding Trial Evaluating the Effect and Safety of Once-weekly Treatment of Somapacitan Compared to Daily Norditropin® in Children With Short Stature Born Small for Gestational Age With no Catch-up Growth by 2 Years of Age or Older 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
2018-000232-10  EudraCT 
NCT03878446  ClinicalTrials.gov 
NN8640-4245, Version 3.0, Dated 17 July 2019  Protocol Number 
U1111-1207-9741  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr Maya Sharma 
Designation  Vice President - Clinical, Medical, Regulatory & Pharmacovigilance 
Affiliation  Novo Nordisk India Private Ltd 
Address  Novo Nordisk India Private Ltd. NXT-2, 1 & 2nd Floor, Embassy Manyata Business Park, Nagavara Village, Kasaba Hobli, Bangalore - 560045
Novo Nordisk India Private Ltd. NXT-2, 1 & 2nd Floor, Embassy Manyata Business Park, Nagavara Village, Kasaba Hobli, Bangalore - 560045
Bangalore
KARNATAKA
560045
India 
Phone  9911497869  
Fax  080-41123518  
Email  yrms@novonordisk.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Dr Maya Sharma 
Designation  Vice President - Clinical, Medical, Regulatory & Pharmacovigilance 
Affiliation  Novo Nordisk India Private Ltd 
Address  Novo Nordisk India Private Ltd. NXT-2, 1 & 2nd Floor, Embassy Manyata Business Park, Nagavara Village, Kasaba Hobli, Bangalore - 560045
Novo Nordisk India Private Ltd. NXT-2, 1 & 2nd Floor, Embassy Manyata Business Park, Nagavara Village, Kasaba Hobli, Bangalore - 560045
Bangalore
KARNATAKA
560045
India 
Phone  9911497869  
Fax  080-41123518  
Email  yrms@novonordisk.com  
 
Source of Monetary or Material Support  
Novo Nordisk India Private Ltd, Plot No.32, 47 - 50, EPIP Area, Whitefield, Bangalore - 560 066, India 
 
Primary Sponsor  
Name  Novo Nordisk AS 
Address  Novo Allé, 2880 Bagsvaerd Denmark 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment
Modification(s)  		   Slovakia
Algeria
Austria
Canada
Denmark
Estonia
France
Hungary
India
Ireland
Israel
Italy
Japan
Latvia
Norway
Poland
Russian Federation
Serbia
Spain
Switzerland
Thailand
Ukraine
United Kingdom
United States of America  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rajesh Khadgawat  All India Institute of Medical Sciences  Room No 303, Dept of Endocrinology & Metabolism, Biotechnology Block, Ansari Nagar, New Delhi- 110029, India
New Delhi
DELHI 		 9891418190

rajeshkhadgawat@hotmail.com 
Dr Praveen Valliyaparambil Pavithran  Amrita Institute of Medical Sciences & Research Centre  Amrita Institute of Medical Sciences & Research Centre, Dept of Endocrinology and Diabetes, AIMS, Ponekkara. P.O,Kochi, Kerala-682041
Kozhikode
KERALA 		 9446742989

praveenvp@aims.amrita.edu 
Dr Khadilkar Vaman Vasant  Jehangir Clinical Development Centre  Jehangir Hospital Premises, 32, Sassoon Road, Pune, Maharashtra- 411001, India
Pune
MAHARASHTRA 		 9860027285

vaman.khadilkar@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Ethics Committee,Jehangir Clinical Development Centre Pvt Ltd  Approved 
Institute Ethics Committee, AIIMS  Approved 
Institutional Ethics Committee, Amrita Institute of Medical Sciences & Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E20-E35||Disorders of other endocrine glands,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Norditropin®   Norditropin® injected under the skin once a day for a total of 52 weeks 
Intervention  somapacitan   Somapacitan injected under the skin once a week for a total of 52 weeks 
 
Inclusion Criteria
Modification(s)  
Age From  2.00 Year(s)
Age To  11.00 Year(s)
Gender  Both 
Details  Subjects are eligible to be included in the trial only if all of the following criteria apply:
1. Informed consent of parent or legally acceptable representative of subject and child assent, as
age-appropriate must be obtained before any trial-related activities.
a) The parent or legally acceptable representative of the child must sign and date the
Informed Consent Form (according to local requirements).
b) The child must sign and date the Child Assent Form or provide oral assent (if required
according to local requirements).
2. Pre-pubertal children:
a) Boys:
o Age ≥ 2 years and 26 weeks and < 11.0 years at screening.
o Testes volume < 4 ml.
b) Girls:
o Age ≥ 2 years and 26 weeks and < 10.0 years at screening.
o Tanner stage 1 for breast development (no palpable glandular breast
tissue).
3. Born small for gestational age (birth length and/or weight < -2 SDS) (according to national
standards).
For Israel and Japan: see Appendix 9
4. Impaired height defined as at least 2.5 standard deviations below the mean height for
chronological age and gender at screening according to the standards of Centers for Disease
Control and Prevention.
For India: see Appendix 9
5. Impaired height velocity defined as annualised height velocity below the 50th percentile for
chronological age and gender according to the standards of Prader calculated over a time span
of minimum 6 months and maximum 18 months prior to screening.
6. No prior exposure to growth hormone therapy or IGF-I treatment.
7. Gestational age at birth ≥ 32 weeks.
8. Body Mass Index <95th percentile according to Centers for Disease Control and Prevention,
Body Mass Index-for-age growth charts.
For India: see Appendix 9
 
 
ExclusionCriteria 
Details  Subjects are excluded from the trial if any of the following criteria apply:
1. Known or suspected hypersensitivity to trial product(s) or related products.
2. Previous participation in this trial. Participation is defined as randomisation.
3. Receipt of any investigational medicinal product within 3 months before screening or
participation in another clinical trial at time of randomisation.
4. Any known or suspected clinically significant abnormality likely to affect growth or the ability
to evaluate growth with standing height measurements:
a) Turner Syndrome (including mosaicisms)
b) Chromosomal aneuploidy and significant gene mutations causing medical “syndromes”
with short stature, including but not limited to Laron syndrome, Noonan syndrome,
Prader-Willi Syndrome, abnormal SHOX-1 gene analysis or absence of GH receptors
c) Significant spinal abnormalities including but not limited to scoliosis, kyphosis and
spina bifida variants
d) Congenital abnormalities (causing skeletal abnormalities), including but not limited to
Russell-Silver Syndrome or skeletal dysplasias
e) Family history of skeletal dysplasia
For India: see Appendix 9
5. Children with hormonal deficiencies including suspected or confirmed growth hormone
deficiency according to local practise.
6. Children diagnosed with diabetes mellitus or screening values from central laboratory of
a) Fasting plasma glucose ≥126 mg/dl (7.0 mmol/L) or
b) HbA1c ≥ 6.5 %
7. Current inflammatory diseases requiring systemic corticosteroid treatment for longer than 2
consecutive weeks within the last 3 months prior to screening.
8. Children requiring inhaled glucocorticoid therapy at a dose of greater than 400 μg/day of
inhaled budesonide or equivalents for longer than 4 consecutive weeks within the last 12 months
prior to screening.
9. Concomitant administration of other treatments that may have an effect on growth, e.g. but not
limited to methylphenidate for treatment of attention deficit hyperactivity disorder (ADHD).
10. Diagnosis of attention deficit hyperactivity disorder.
11. Prior history or known presence of malignancy including intracranial tumours.
12. Prior history or known presence of active Hepatitis B or Hepatitis C (exceptions to this
exclusion criterion is the presence of antibodies due to vaccination against Hepatitis B).
13. Any disorder which, in the opinion of the investigator, might jeopardise subject’s safety or
compliance with the protocol.
For France, Spain, and UK: see Appendix 9
14. The subject or the parent/legally acceptable representative is likely to be non-compliant in
respect to trial conduct, as judged by the investigator.
15. Children who are small due to malnutrition defined as -2 SD according to standards: 0-5 years:
weight for height on World Health Organisation Multicentre Growth Reference Study 2006 and
>5 years: World Health Organisation 2007 Body Mass Index.
For India: see Appendix 9
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Height velocity   Time Frame: From baseline (week 0) to week 26
Unit : cm/year 
 
Secondary Outcome  
Outcome  TimePoints 
Change in bone age   Time Frame: From baseline (week 0) to week 52
unit: years 
Change in height standard deviation score (SDS)
 		 From baseline (week 0) to week 26
unit : minus 10 to Plus 10 
Change in height velocity SDS   From baseline (week 0) to week 26
unit : minus 10 to plus 10 
Change in fasting plasma glucose   From screening (visit 1) to week 26
unit :mmol/l 
Change in homeostatic model assessment (HOMA)   From screening (visit 1) to week 26
unit:percent 
Change in glycated haemoglobin (HbA1c)  From screening (visit 1) to week 26
unit:Percentage points 
Change in insulin-like growth factor I (IGF-I) SDS   From screening (visit 1) to week 26
unit : minus 10 to plus 10 
Change in insulin-like growth factor binding protein 3 (IGFBP-3) SDS   From screening (visit 1) to week 26
unit: minus 10 to plus 10 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="10" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   24/08/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  04/07/2019 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The study compares 2 medicines used for the treatment of children who are born small and who stayed small: somapacitan given once a week (a new medicine) and Norditropin® given once a day (the medicine doctors can already prescribe).

Participants will either get somapacitan or Norditropin® - which treatment is decided by chance. Both participants and the study doctor will know which treatment the participants get. The study will last for 2 years. Participants will take either an injection once every week or once every day. Participants will have 9 clinic visits and will be in the study for 1 year. The follow-up period is at least 30 days.

 
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