A Research Study in Chinese Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day.

Last updated: October 12, 2025
Sponsor: Novo Nordisk A/S
Overall Status: Completed

Phase

3

Condition

Growth Hormone Deficiencies/abnormalities

Treatment

somapacitan

Norditropin®

Clinical Study ID

NCT04970654
NN8640-4468
2020-002974-28
U1111-1250-7530
  • All Genders

Study Summary

The study compares two medicines for children with a low level of hormone to grow: somapacitan (a new medicine) given once a week and Norditropin® (a medicine doctors can already prescribe) given once a day. Researchers will test somapacitan to see how well it works, compared to the standard treatment with Norditropin®. The participants will either get Norditropin® once every day or somapacitan once every week - which treatment the participant gets is decided by chance. The participant and the study doctor will know which treatment the participant gets. The study includes a 52 week treatment period and a minimum of 30 days follow up period.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Informed consent of parent or legally acceptable representative of participant andchild assent, as age-appropriate must be obtained before any trial relatedactivities

  • The parent or legally acceptable representative of the child must sign and date theInformed consent form (according to local requirements)

  • The child must sign and date child assent form or provide oral assent (if requiredaccording to local requirements)

  • Prepubertal children: a) Boys: Age more than or equal to 2 years and 26 weeks andless than or equal to 11.0 years at the time of signing informed consent.

  • Testis volume less than 4 ml. b) Girls: Age more than or equal to 2 years and 26weeks and less than or equal to 10.0 years at the time of signing informed consent.Tanner stage 1 for breast development (no palpable glandular breast tissue)

  • Confirmed diagnosis of growth hormone deficiency determined by two different growthhormone stimulation tests performed within 12 months prior to randomisation, definedas a peak growth hormone level of less than or equal to 10.0 ng/ml using the WHOInternational Somatropin 98/574 standard

  • If only one growth hormone stimulation test is available before screening, thenconfirmation of growth hormone deficiency by second and different growth hormonestimulation test must be done

  • For children with at least 2 additional pituitary hormone deficiencies (other thangrowth hormone deficiency) only one growth hormone stimulation test is needed

  • Impaired height defined as at least 2.0 standard deviations below the mean heightfor chronological age and gender according to Chinese general population standardsat screening

  • Impaired height velocity defined as annualised height velocity at screening lessthan 7cm/year for subjects between 2.5 and 3 years old and less than 5 cm/year forsubjects from 3 years and above calculated over a time span of minimum 3 months andmaximum 18 months prior to screening according to Chinese guideline and expertconsensus on children with short stature and GH therapy

  • No prior exposure to growth hormone therapy or IGF-I treatment

  • Bone age less than chronological age at screening

  • Body Mass Index more than 5th and less than 95th percentile, Body Mass Index-for-agegrowth charts according to Chinese general population standards.

  • IGF-I < -1.0 SDS at screening, compared to age and gender normalized range measuredat central laboratory

  • No intracranial tumour confirmed by magnetic resonance imaging or computertomography scan. An image or scan taken within 9 months prior to screening can beused as screening data if the medical evaluation and conclusion is available

Exclusion

Exclusion Criteria:

  • Known or suspected hypersensitivity to trial product(s) or related products.

  • Previous participation in this trial. Participation is defined as randomisation.

  • Receipt of any investigational medicinal product within 3 months before screening orparticipation in another clinical trial before randomisation

  • Any known or suspected clinically significant abnormality likely to affect growth orthe ability to evaluate growth with standing height measurements:

  • Turner Syndrome (including mosaicisms)

  • 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

  • Significant spinal abnormalities including but not limited to scoliosis, kyphosisand spina bifida variants

  • Congenital abnormalities (causing skeletal abnormalities), including but not limitedto Russell-Silver Syndrome or skeletal dysplasias

  • Family history of skeletal dysplasia

  • Children born small for gestational age (birth weight 10th percentile of therecommended gender-specific birth weight for gestational age according to nationalstandards in China5

  • Children diagnosed with diabetes mellitus or screening values from centrallaboratory of

  1. fasting plasma glucose more than or equal to 126 mg/dl (7.0 mmol/L) or

  2. HbA1c more than or equal to 6.5 %

  • Current inflammatory diseases requiring systemic corticosteroid treatment for longerthan 2 consecutive weeks within the last 3 months prior to screening

  • Children requiring inhaled glucocorticoid therapy at a dose greater than 400 µg/dayof inhaled budesonide or equivalents for longer than 4 consecutive weeks within thelast 12 months prior to screening

  • Concomitant administration of other treatments that may have an effect on growth,e.g. but not limited to methylphenidate for treatment of attention deficithyperactivity disorder (ADHD)

  • Diagnosis of attention deficit hyperactivity disorder

  • Prior history or presence of malignancy including intracranial tumours

  • Prior history or known presence of active Hepatitis B or Hepatitis C (exceptions tothis exclusion criterion is the presence of antibodies due to vaccination againstHepatitis B)

  • Any clinically significant abnormal laboratory screening tests, as judged by thestudy doctor

  • Any disorder which, in the opinion of the study doctor, might jeopardiseParticipant's safety or compliance with the protocol

  • The participant or the parent/legally acceptable representative is likely to benon-compliant in respect to trial conduct, as judged by the study doctor

  • Children with hypothyroidism and/or adrenal insufficiency not on adequate and stablereplacement therapy for at least 90 days prior to randomisation.

Study Design

Total Participants: 110
Treatment Group(s): 2
Primary Treatment: somapacitan
Phase: 3
Study Start date:
July 22, 2021
Estimated Completion Date:
December 18, 2023

Connect with a study center

  • Novo Nordisk Investigational Site

    Hefei, Anhui 230601
    China

    Completed

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui 230601
    China

    Site Not Available

  • The Second Hospital of Anhui Medical University

    Hefei 1808722, Anhui 1818058 230601
    China

    Site Not Available

  • Beijing Children's Hospital,Capital Medical University

    Beijing, Beijing 100045
    China

    Site Not Available

  • Capital Institute of Paediatrics

    Beijing, Beijing 100020
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Beijing, Beijing 100045
    China

    Site Not Available

  • Beijing Children's Hospital, Capital Medical University

    Beijing 1816670, Beijing Municipality 2038349 100045
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Guangzhou, Guangdong 510080
    China

    Completed

  • The First Affiliated Hospital , Sun Yat-sen University

    Guangzhou, Guangdong 510080
    China

    Site Not Available

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou 1809858, Guangdong 1809935 510080
    China

    Site Not Available

  • Henan Children's Hospital

    Zhengzhou, Henan 450018
    China

    Site Not Available

  • Henan Children's Hospital Zhengzhou Children's Hospital

    Zhengzhou, Henan 450018
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Zhengzhou, Henan 450018
    China

    Active - Recruiting

  • Henan Children's Hospital

    Zhengzhou 1784658, Henan 1808520 450018
    China

    Site Not Available

  • Henan Children's Hospital Zhengzhou Children's Hospital-Endocrine Genetics and Metabolism

    Zhengzhou 1784658, Henan 1808520 450018
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Wuhan, Hubei 430030
    China

    Completed

  • Tongji Hospital,Tongji Medical College of Huazhong University of Science &Technology

    Wuhan, Hubei 430030
    China

    Site Not Available

  • Tongji Hospital, Tongji Medical College of HUST-Pediatric

    Wuhan 1791247, Hubei 1806949 430030
    China

    Site Not Available

  • Hunan Children's Hospital

    Changsha, Hunan 410007
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Changsha, Hunan 410007
    China

    Active - Recruiting

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan 410011
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Shaoyang, Hunan 422000
    China

    Completed

  • The First Affiliated Hospital of Shaoyang University

    Shaoyang, Hunan 422001
    China

    Site Not Available

  • Hunan Children's Hospital

    Changsha 1815577, Hunan 1806691 410007
    China

    Site Not Available

  • Hunan Children's Hospital-Child Health Center

    Changsha 1815577, Hunan 1806691 410007
    China

    Site Not Available

  • The Second Xiangya Hospital of Central South University

    Changsha 1815577, Hunan 1806691 410011
    China

    Site Not Available

  • The First Affiliated Hospital of Shaoyang University-Pediatric

    Shaoyang 1816920, Hunan 1806691 422001
    China

    Site Not Available

  • Children's Hospital of Soochow University

    Suzhou, Jiangsu 215025
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Suzhou, Jiangsu 215025
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Wuxi, Jiangsu 214023
    China

    Active - Recruiting

  • Wuxi Children's Hospital

    Wuxi, Jiangsu 214023
    China

    Site Not Available

  • Jiangxi Provincial Children's Hospital-Endocrine Genetics and Metabolism

    Nanchang 7528770, Jiangsu 1806260 330006
    China

    Site Not Available

  • Children's Hospital of Soochow University

    Suzhou 1886760, Jiangsu 1806260 215025
    China

    Site Not Available

  • Children's Hospital of Soochow University-Endocrine Genetics and Metabolism

    Suzhou 1886760, Jiangsu 1806260 215025
    China

    Site Not Available

  • Wuxi Children's Hospital

    Wuxi 1790923, Jiangsu 1806260 214023
    China

    Site Not Available

  • Wuxi Children's Hospital-Pediatric Endocrinology

    Wuxi 1790923, Jiangsu 1806260 214023
    China

    Site Not Available

  • Jiangxi Provincial Children's Hospital

    Nanchang, Jiangxi 330006
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Nanchang, Jiangxi 330006
    China

    Completed

  • Novo Nordisk Investigational Site

    Pingxiang, Jiangxi 337055
    China

    Active - Recruiting

  • Pingxiang Maternal and Child Health Care Hospital

    Pingxiang, Jiangxi 337055
    China

    Site Not Available

  • The First Hospital of Jiaxing

    Jiaxing, Jiangxi 1806222 314001
    China

    Site Not Available

  • The First Hospital of Jiaxing-Pediatric

    Jiaxing, Jiangxi 1806222 314001
    China

    Site Not Available

  • Pingxiang Maternal and Child Health Care Hospital

    Pingxiang 1798654, Jiangxi 1806222 337055
    China

    Site Not Available

  • Pingxiang Maternal and Child Health Care Hospital-Child Health Care

    Pingxiang 1798654, Jiangxi 1806222 337055
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Changchun, Jilin 130021
    China

    Site Not Available

  • The First Hospital of Jilin University

    Changchun, Jilin 130021
    China

    Site Not Available

  • The First Bethune Hospital of Jilin University-Pediatric

    Changchun 2038180, Jilin 2036500 130021
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Jinan, Shandong 250021
    China

    Completed

  • Shandong Provincial Hospital

    Jinan, Shandong 250098
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Linyi, Shandong 276016
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Qingdao, Shandong 266043
    China

    Active - Recruiting

  • Qingdao Women and Children's Hospital

    Qingdao, Shandong 266043
    China

    Site Not Available

  • Shandong Provincial Hospital-Pediatric

    Jinan 1805753, Shandong 1796328 250098
    China

    Site Not Available

  • Qingdao Women and Children's Hospital

    Qingdao 1797929, Shandong 1796328 266043
    China

    Site Not Available

  • Qingdao Women and Children's Hospital-Pediatric Endocrinology&Metabolism

    Qingdao 1797929, Shandong 1796328 266034
    China

    Site Not Available

  • Chengdu Women's and Children's central hospital

    Chengdu, Sichuan 610000
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Chengdu, Sichuan 610000
    China

    Completed

  • Chengdu Women's and Children's Central Hospital

    Chengdu 1815286, Sichuan 1794299 610000
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Hangzhou, Zhejiang 310003
    China

    Site Not Available

  • The Children's Hospital, Zhejiang University school of medicine

    Hangzhou, Zhejiang 310052
    China

    Site Not Available

  • Novo Nordisk Investigational Site

    Jiaxing, Zhejiang 314000
    China

    Completed

  • Children's Hospital, Zhejiang University School of Medicine

    Hangzhou 1808926, Zhejiang 1784764 310052
    China

    Site Not Available

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