Weekly shot may replace daily needle for kids with growth hormone deficiency

NCT ID NCT04970654

Disease control Sponsor: Novo Nordisk A/S Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new medicine, somapacitan, given once a week against the standard daily growth hormone shot (Norditropin®) in 110 Chinese children with growth hormone deficiency. The goal was to see if the weekly shot works as well as the daily one for helping children grow. Children were randomly assigned to one treatment for 52 weeks, and researchers measured their growth rate and bone development.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

110 people

The number who actually took part.

Started

Jul 2021

Finished

Dec 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Informed consent of parent or legally acceptable representative of participant and child assent, as age-appropriate must be obtained before any trial related activities * The parent or legally acceptable representative of the child must sign and date the Informed consent form (according to local requirements) * The child must sign and date child assent form or provide oral assent (if required according to local requirements) * Prepubertal children: a) Boys: Age more than or equal to 2 years and 26 weeks and less 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 26 weeks 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 growth hormone stimulation tests performed within 12 months prior to randomisation, defined as a peak growth hormone level of less than or equal to 10.0 ng/ml using the WHO International Somatropin 98/574 standard * If only one growth hormone stimulation test is available before screening, then confirmation of growth hormone deficiency by second and different growth hormone stimulation test must be done * For children with at least 2 additional pituitary hormone deficiencies (other than growth hormone deficiency) only one growth hormone stimulation test is needed * Impaired height defined as at least 2.0 standard deviations below the mean height for chronological age and gender according to Chinese general population standards at screening * Impaired height velocity defined as annualised height velocity at screening less than 7cm/year for subjects between 2.5 and 3 years old and less than 5 cm/year for subjects from 3 years and above calculated over a time span of minimum 3 months and maximum 18 months prior to screening according to Chinese guideline and expert consensus 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-age growth charts according to Chinese general population standards. * IGF-I \< -1.0 SDS at screening, compared to age and gender normalized range measured at central laboratory * No intracranial tumour confirmed by magnetic resonance imaging or computer tomography scan. An image or scan taken within 9 months prior to screening can be used as screening data if the medical evaluation and conclusion is available 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 or participation in another clinical trial before randomisation * Any known or suspected clinically significant abnormality likely to affect growth or the 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, kyphosis and spina bifida variants * Congenital abnormalities (causing skeletal abnormalities), including but not limited to Russell-Silver Syndrome or skeletal dysplasias * Family history of skeletal dysplasia * Children born small for gestational age (birth weight 10th percentile of the recommended gender-specific birth weight for gestational age according to national standards in China5 * Children diagnosed with diabetes mellitus or screening values from central laboratory 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 longer than 2 consecutive weeks within the last 3 months prior to screening * Children requiring inhaled glucocorticoid therapy at a dose greater than 400 µg/day of inhaled budesonide or equivalents for longer than 4 consecutive weeks within the last 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 deficit hyperactivity 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 to this exclusion criterion is the presence of antibodies due to vaccination against Hepatitis B) * Any clinically significant abnormal laboratory screening tests, as judged by the study doctor * Any disorder which, in the opinion of the study doctor, might jeopardise Participant's safety or compliance with the protocol * The participant or the parent/legally acceptable representative is likely to be non-compliant in respect to trial conduct, as judged by the study doctor * Children with hypothyroidism and/or adrenal insufficiency not on adequate and stable replacement therapy for at least 90 days prior to randomisation.

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Conditions

The condition(s) this trial relates to.

isolated congenital growth hormone deficiency

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Growth hormone deficiency in children

Contacts and locations

Locations

Beijing Children's Hospital, Capital Medical University

Beijing, Beijing Municipality, 100045, China
Capital Center for Children's Health, Capital Medical University-Endocrinology

Beijing, Beijing Municipality, 100020, China
Chengdu Women's and Children's Central Hospital

Chengdu, Sichuan, 610000, China
Children's Hospital of Soochow University

Suzhou, Jiangsu, 215025, China
Children's Hospital of Soochow University-Endocrine Genetics and Metabolism

Suzhou, Jiangsu, 215025, China
Children's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310052, China
Henan Children's Hospital

Zhengzhou, Henan, 450018, China
Henan Children's Hospital Zhengzhou Children's Hospital-Endocrine Genetics and Metabolism

Zhengzhou, Henan, 450018, China
Hunan Children's Hospital

Changsha, Hunan, 410007, China
Hunan Children's Hospital-Child Health Center

Changsha, Hunan, 410007, China
Jiangxi Provincial Children's Hospital-Endocrine Genetics and Metabolism

Nanchang, Jiangsu, 330006, China
Pingxiang Maternal and Child Health Care Hospital

Pingxiang, Jiangxi, 337055, China
Pingxiang Maternal and Child Health Care Hospital-Child Health Care

Pingxiang, Jiangxi, 337055, China
Qingdao Women and Children's Hospital

Qingdao, Shandong, 266043, China
Qingdao Women and Children's Hospital-Pediatric Endocrinology&Metabolism

Qingdao, Shandong, 266034, China
Shandong Provincial Hospital-Pediatric

Jinan, Shandong, 250098, China
Shanghai Children's Hospital

Shanghai, Shanghai Municipality, 200062, China
The First Affiliated Hospital of Shaoyang University-Pediatric

Shaoyang, Hunan, 422001, China
The First Affiliated Hospital of Xiamen University-Pediatric

Xiamen, Fujian, 361003, China
The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China
The First Bethune Hospital of Jilin University-Pediatric

Changchun, Jilin, 130021, China
The First Bethune hospital of Jilin University-Endocrinology

Changchun, Julin, China
The First Hospital of Jiaxing

Jiaxing, Jiangxi, 314001, China
The First Hospital of Jiaxing-Pediatric

Jiaxing, Jiangxi, 314001, China
The Second Hospital of Anhui Medical University

Hefei, Anhui, 230601, China
The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China
The Third Affiliated Hospital, Sun Yat-Sen University-Pediatric

Guangzhou, Guangdong, 510630, China
Tongji Hospital, Tongji Medical College of HUST-Pediatric

Wuhan, Hubei, 430030, China
Women & Children's Health Care Hospital of Linyi-Endocrine Genetics and Metabolism

Linyi, Shandong, 276016, China
Wuhan Children Hospital-Endocrine Genetics and Metabolism

Wuhan, China
Wuxi Children's Hospital

Wuxi, Jiangsu, 214023, China
Wuxi Children's Hospital-Pediatric Endocrinology

Wuxi, Jiangsu, 214023, China

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