A study comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® as well as evaluating long-term safety of somapacitan in a basket study design in children with short stature either born small for gestational age or with Turner syndrome, Noonan syndrome, or idiopathic short stature

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-506927-27-00

Acronym

NN8640-4467

Enrollment

135

Registered

2024-07-15

Start date

2022-08-29

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children with short stature either born small for gestational age or with Turner syndrome, Noonan syndrome, or idiopathic short stature

Brief summary

Height velocity

Detailed description

Change in Height SDS, Change in Height Velocity SDS, Change in bone age, Change in IGF-I SDS, Change in IGFBP-3 SDS, Change in fasting plasma glucose, Change in homeostatic model assessment-B (HOMA-B), Change in homeostatic model assessment-IR (HOMA-IR), Change in glycated haemoglobin (HbA1c), CCI

Interventions

DRUGSogroya 5 mg/1.5 mL solution for injection in pre-filled pen

DRUGSogroya 15 mg/1.5 mL solution for injection in pre-filled pen

DRUGSogroya 10 mg/1.5 mL solution for injection in pre-filled pen

DRUGNorditropin FlexPro

DRUGinjektionsvæske

DRUGopløsning i fyldt pen

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Height velocity	—

Secondary

Measure	Time frame
Change in Height SDS, Change in Height Velocity SDS, Change in bone age, Change in IGF-I SDS, Change in IGFBP-3 SDS, Change in fasting plasma glucose, Change in homeostatic model assessment-B (HOMA-B), Change in homeostatic model assessment-IR (HOMA-IR), Change in glycated haemoglobin (HbA1c), CCI	—

Countries

Austria, Belgium, Bulgaria, Croatia, Finland, France, Germany, Greece, Italy, Latvia, Lithuania, Netherlands, Poland, Portugal, Slovenia, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026