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A Research Study Looking at How Safe Somapacitan is and How Well it Works in Children Who Need Help to Grow - REAL 9

Locations

Not recruiting

Start date

01/02/2023

Identifiers

Trial ID NN8640-4469,
NCT number NCT05723835,
Eudract number 2022-501055-87

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.

Trial Overview:

Condition

SGA

Turner Syndrome

Noonan Syndrome

ISS

Treatment

DRUG: Somapacitan

Study type

INTERVENTIONAL

Trial duration

Feb 01 2023 - Oct 29 2027

Participants

48

Phase

III

Are you eligible?

Gender

Male and female

Age

10 to 18 years old

Questions or concerns

Do you have any question about what it’s like being a clinical volunteer? Have a look at our answers to frequently asked questions.

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