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NCT05723835
A Research Study Looking at How Safe Somapacitan is and How Well it Works in Children Who Need Help to Grow - REAL 9
Conditions: SGA, Turner Syndrome, Noonan Syndrome, ISS
Sex: All
Ages: 10 Years – 18 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 47
Sponsor: Novo Nordisk A/S
Location: Univ of AL at Birmingham_BRM Birmingham Alabama
Summary
The purpose of this study is to find out if somapacitan is safe and how well somapacitan works in children either born small for gestational age or with Turner syndrome, Noonan syndrome or idiopathic short stature. Somapacitan is a new growth hormone medicine for treatment of low level of growth hormone. The study will last for about 3 years. During the study, the participants will be treated with somapacitan once a week. Somapacitan can be injected anytime during the day. The study doctor or nurse will show how to inject somapacitan, so that the participant knows how to do it at home.
Eligibility Criteria
Inclusion Criteria:
Applicable to children with SGA:
* Born small for gestational age (birth length below -2 SDS OR birth weight below -2 SDS OR both) (according to national standards).
* Age:
\- Male participants: Age equal to or above 11.0 years and below 18.0 years at screening.
\- Female participants: Age equal to or above 10.0 years and below 18.0 years at screening.
* Open epiphyses; defined as bone age less than (\
Source: ClinicalTrials.gov (NCT05723835). StuddyBuddy aggregates publicly available trial information.
