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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. | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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.

A Trial Comparing the Efficacy and Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® in Chinese Children With Growth Hormone Deficiency

NCT04970654•Novo Nordisk A/S

View on ClinicalTrials.gov

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

Age

All ages

Sex

ALL

Healthy Volunteers

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
+5 more criteria

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
+13 more criteria

Locations (32)

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

Key Dates

Start Date

July 22, 2021

Primary Completion Date

November 17, 2023

Completion Date

December 18, 2023

Last Updated

January 6, 2026

Enrollment

110

ACTUAL participants

Conditions

Growth Hormone Deficiency in Children

Interventions

somapacitan

DRUG

Norditropin®

DRUG

Special Use-results Surveillance on Long Term Use of Sogroya® in Children With Short Stature Due to Growth Hormone Deficiency Where Epiphysial Discs Are Not Closed

NCT06109935

Growth Hormone Deficiency in Children

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COMPLETEDPHASE1

First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy Subjects

NCT01514500

Growth Hormone DisorderAdult Growth Hormone Deficiency+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 6, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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.

Inclusion Criteria

Exclusion Criteria

Special Use-results Surveillance on Long Term Use of Sogroya® in Children With Short Stature Due to Growth Hormone Deficiency Where Epiphysial Discs Are Not Closed

First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy Subjects

Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Various Degrees of Impaired Renal Function Compared to Subjects With Normal Renal Function

Observational Prospective Study on Patients Treated With Norditropin®

Norditropin NordiFlex® Device Compared to the Device Previously Used by Patients or Parents

An Observational Study on Treatment Compliance by Children Treated With Growth Hormone