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.

NCT ID: NCT04970654

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-22
• Study Completion Date: 2023-12-18

Brief 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.

Conditions

Growth Hormone Deficiency in Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Somapacitan weekly

participants will receive once-weekly somapacitan for 52 weeks

Group Type: EXPERIMENTAL

somapacitan

Intervention Type: DRUG

Somapacitan (0.16 mg/kg/week) 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.

Norditropin® daily

Participants will receive Norditropin® daily for 52 weeks

Group Type: ACTIVE_COMPARATOR

Norditropin®

Intervention Type: DRUG

Norditropin® (0.034 mg/kg/day) 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.

Interventions

somapacitan

Somapacitan (0.16 mg/kg/week) 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.

Intervention Type: DRUG

Norditropin®

Norditropin® (0.034 mg/kg/day) 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Transparency (dept. 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

The Second Hospital of Anhui Medical University

Hefei, Anhui, China

Capital Center for Children's Health, Capital Medical University-Endocrinology

Beijing, Beijing Municipality, China

Beijing Children's Hospital, Capital Medical University

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Xiamen University-Pediatric

Xiamen, Fujian, China

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

The Third Affiliated Hospital, Sun Yat-Sen University-Pediatric

Guangzhou, Guangdong, China

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

Zhengzhou, Henan, China

Henan Children's Hospital

Zhengzhou, Henan, China

Tongji Hospital, Tongji Medical College of HUST-Pediatric

Wuhan, Hubei, China

Hunan Children's Hospital-Child Health Center

Changsha, Hunan, China

Hunan Children's Hospital

Changsha, Hunan, China

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

The First Affiliated Hospital of Shaoyang University-Pediatric

Shaoyang, Hunan, China

Jiangxi Provincial Children's Hospital-Endocrine Genetics and Metabolism

Nanchang, Jiangsu, China

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

Suzhou, Jiangsu, China

Children's Hospital of Soochow University

Suzhou, Jiangsu, China

Wuxi Children's Hospital-Pediatric Endocrinology

Wuxi, Jiangsu, China

Wuxi Children's Hospital

Wuxi, Jiangsu, China

The First Hospital of Jiaxing-Pediatric

Jiaxing, Jiangxi, China

The First Hospital of Jiaxing

Jiaxing, Jiangxi, China

Pingxiang Maternal and Child Health Care Hospital-Child Health Care

Pingxiang, Jiangxi, China

Pingxiang Maternal and Child Health Care Hospital

Pingxiang, Jiangxi, China

The First Bethune Hospital of Jilin University-Pediatric

Changchun, Jilin, China

The First Bethune hospital of Jilin University-Endocrinology

Changchun, Julin, China

Shandong Provincial Hospital-Pediatric

Jinan, Shandong, China

Women & Children's Health Care Hospital of Linyi-Endocrine Genetics and Metabolism

Linyi, Shandong, China

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

Qingdao, Shandong, China

Qingdao Women and Children's Hospital

Qingdao, Shandong, China

Shanghai Children's Hospital

Shanghai, Shanghai Municipality, China

Chengdu Women's and Children's Central Hospital

Chengdu, Sichuan, China

Children's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Wuhan Children Hospital-Endocrine Genetics and Metabolism

Wuhan, , China

Countries

China

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

U1111-1250-7530

Identifier Type: OTHER

Identifier Source: secondary_id

2020-002974-28

Identifier Type: OTHER

Identifier Source: secondary_id

NN8640-4468

Identifier Type: -

Identifier Source: org_study_id