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

Novo Nordisk A/S57 sites in 1 country110 target enrollmentJuly 22, 2021

ConditionsGrowth Hormone Deficiency in Children

Interventionssomapacitan Norditropin®

Drugssomapacitan Norditropin®

Overview

Phase: Phase 3
Intervention: somapacitan
Conditions: Growth Hormone Deficiency in Children
Sponsor: Novo Nordisk A/S
Enrollment: 110
Locations: 57
Primary Endpoint: Height Velocity
Status: Completed
Last Updated: 3 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 22, 2021

End Date

December 18, 2023

Last Updated

3 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novo Nordisk A/S

Responsible Party

Sponsor

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

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

Arms & Interventions

Somapacitan weekly

participants will receive once-weekly somapacitan for 52 weeks

Intervention: somapacitan

Norditropin® daily

Participants will receive Norditropin® daily for 52 weeks

Intervention: Norditropin®

Outcomes

Primary Outcomes

Height Velocity

Time Frame: Baseline (Week 0); Week 52

Height velocity (HV) was derived from height measurements taken at baseline (week 0) and the week 52 visit as: HV = (height at 52 weeks visit - height at baseline)/(time from baseline to 52 weeks visit in years).