Somapacitan for Small for Gestational Age, Turner Syndrome, Noonan Syndrome, Intrauterine Growth Restriction.

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Small for Gestational Age, Turner Syndrome, Noonan Syndrome, Intrauterine Growth Restriction.Somapacitan - Drug
Eligibility
2 - 10
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new growth hormone against a current one to see if it's more effective in children with Turner Syndrome, Noonan Syndrome, Idiopathic Short Stature, or who were born small and stay small.

Eligible Conditions
  • Small for Gestational Age, Turner Syndrome, Noonan Syndrome, Intrauterine Growth Restriction.

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 12 Secondary · Reporting Duration: From screening (visit 1) to visit 15 (week 156)

Week 52
Change in Height Velocity SDS reported separately for SGA, TS, NS and ISS
Change in Height standard deviation scores (SDS) reported separately for SGA, TS, NS and ISS
Change in bone age reported separately for SGA, TS and NS
Height velocity reported separately for small for gestational age (SGA), Turner syndrome (TS), Noonan syndrome (NS) and idiopathic short stature (ISS)
Week 52
Change in insulin-like growth factor 1 (IGF-1) SDS reported separately for SGA, TS, NA and ISS
Change in insulin-like growth factor binding protein-3 (IGFBP-3) SDS reported separately for SGA, TS, NA and ISS
Week 156
Change in fasting plasma glucose reported separately for SGA, TS, NS and ISS
Change in glycated haemoglobin (HbA1c) reported separately for SGA, TS, NS and ISS
Change in homeostatic model assessment of insulin resistance (HOMA-IR) reported separately for SGA, TS, NS and ISS
Change in homeostatic model assessment-B (HOMA-B) reported separately for SGA, TS, NS and ISS
Week 52
Change in bone age for ISS
Change in homeostatic model assessment of insulin resistance (HOMAIR) reported separately for SGA, TS, NS and ISS
Week 52
Weekly average somapacitan concentration (Cavg) based on population PK analysis

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Norditropin®
1 of 2
Somapacitan
1 of 2

Active Control

Experimental Treatment

399 Total Participants · 2 Treatment Groups

Primary Treatment: Somapacitan · No Placebo Group · Phase 3

Somapacitan
Drug
Experimental Group · 1 Intervention: Somapacitan · Intervention Types: Drug
Norditropin®
Drug
ActiveComparator Group · 1 Intervention: Norditropin® · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Somapacitan
2017
Completed Phase 1
~80

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from screening (visit 1) to visit 15 (week 156)

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,403 Previous Clinical Trials
2,308,470 Total Patients Enrolled
Clinical Transparency dept. 2834Study DirectorNovo Nordisk A/S
24 Previous Clinical Trials
507,652 Total Patients Enrolled

Eligibility Criteria

Age 2 - 10 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must be between 2 years and 10 months old to 9 years 11 months old at the time of screening.
Your Body Mass Index is lower than the 95th percentile according to Centers for Disease Control and Prevention's Body Mass Index-for-age growth charts.
Before any procedures related to the study are conducted, an informed consent from a parent or legally acceptable representative of the participant must be obtained along with child assent as appropriate.
You have not received any form of growth-stimulating treatment, such as growth hormone, IGF-I and ghrelin analogues.
You were born smaller than the national standard for gestational age, as determined by either your birth length being below -2 SDS or your birth weight being below -2 SDS (or both).
You are between two years, three months and 11 years old.
You have a testicular volume below 4 mL.
Your breast development is immature, with no detectable glandular tissue.
You are of an impaired height as determined by the Centers for Disease Control and Prevention, with a minimum deviation of 2.5 standard deviations below the mean height for your chronological age and gender.
You have a reduced rate of height growth, as indicated by measurements at or below the 50th percentile for your age and gender over a period of between 6 months to 18 months before screening.