Active — Not RecruitingPhase 3

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

United States47 participantsStarted 2023-02-01

Plain-language 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.

Who can participate

Age range10 Years – 18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 (\<) 14 years for females and bone age \< 16 years for males. * For Growth Hormone (GH) treatment naïve participants: Impaired height defined as at least 2.5 standard deviations below the mean height for chronological age and sex at screening according to the standards of Centers for Disease Control and Prevention. Applicable to children with TS: • Diagnosis of TS according to local clinical practice. * Age: \- Female participants: Age equal to or above 10.0 years and below 18.0 years at screening. * Open epiphyses; defined as bone age \< 14 years for females and bone age \< 16 years for males. * For GH treatment naïve participants: Impaired height defined as at least 2.0 standard deviation below the mean height for chronological age and sex at screening according to the standards of Centers for Disease Control and Prevention. * For GH treatment naïve participants: Confirmed diagnosis of TS by 30-cell (or more) lymphocyte chromosomal analysis or confirmation of TS and TS mosaicism using comparative genomic hybridization (CGH)-array. Applicable to…

What they're measuring

Number of Adverse Events (AEs) Reported in Children Born Small for Gestational Age- Weeks 0 to 26

Timeframe: From baseline (Week 0) to Week 26

Number of Adverse Events Reported for Turner Syndrome (TS)- Weeks 0 to 26

Timeframe: From baseline (Week 0) to Week 26

Number of Adverse Events Reported for Noonan Syndrome- Weeks 0 to 26

Timeframe: From baseline (Week 0) to Week 26

Number of Adverse Events Reported for Idiopathic Short Stature (ISS)- Weeks 0 to 26

Timeframe: From baseline (Week 0) to Week 26

Trial details

NCT IDNCT05723835

SponsorNovo Nordisk A/S

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-06-07

Results submitted2025-09-24

View on ClinicalTrials.gov More SGA trials

Plain-language summary

Who can participate

Age range10 Years – 18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Adverse Events (AEs) Reported in Children Born Small for Gestational Age- Weeks 0 to 26

Timeframe: From baseline (Week 0) to Week 26

Number of Adverse Events Reported for Turner Syndrome (TS)- Weeks 0 to 26

Timeframe: From baseline (Week 0) to Week 26

Number of Adverse Events Reported for Noonan Syndrome- Weeks 0 to 26

Timeframe: From baseline (Week 0) to Week 26

Number of Adverse Events Reported for Idiopathic Short Stature (ISS)- Weeks 0 to 26

Timeframe: From baseline (Week 0) to Week 26