A research study looking at how safe somapacitan is and how well it works in children who need help to grow – REAL 9

Phase 1

• Conditions: Idiopathic short stature, Noonan syndrome, Turner’s syndrome, Small for gestational age; MedDRA version: 20.0Level: PTClassification code: 10029748Term: Noonan syndrome Class: 100000004850; MedDRA version: 21.1Level: LLTClassification code: 10041093Term: Small for gestational age Class: 10036585; MedDRA version: 20.0Level: PTClassification code: 10045181Term: Turner's syndrome Class: 100000004850; MedDRA version: 23.0Level: LLTClassification code: 10066333Term: Idiopathic short stature Class: 10028395; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: CTIS2022-501055-87-01
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-02
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Applicable to children with SGA - Born small for gestational age (according to national standards)., Applicable to children with TS - Female participants: Age equal to or above xx years and below xx years at screening., Applicable to children with TS - Open epiphyses; defined as bone age xx years for females and bone age xx years for males., Applicable to children with NS - Diagnosis of NS according to local clinical practice., Applicable to children with NS - Male participants: Age equal to or above xx years and below xx years at screening. Female participants: Age equal to or above xx years and below xx years at screening., Applicable to children with NS - Open epiphyses; defined as bone age xx years for females and bone age xx years for males., Applicable to children with ISS - Male participants: Age equal to or above xx years and below xx years at screening. Female participants: Age equal to or above xx years and below xx years at screening., Applicable to children with ISS - Open epiphyses; defined as bone age xx years for females and bone age xx years for males., Applicable to children with SGA - Male participants: Age equal to or above xx years and below xx years at screening. Female participants: Age equal to or above xx years and below xx years at screening., Applicable to children with SGA - Open epiphyses; defined as bone age xx years for females and bone age xx years for males., Applicable to children with TS - Diagnosis of TS according to local clinical practice.

Exclusion Criteria

Children with suspected or confirmed growth hormone deficiency according to local practice., Children diagnosed with diabetes mellitus or screening values from the central laboratory of fasting plasma glucose above or equal to xx, Current inflammatory diseases requiring xx treatment for longer than xx

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified