A dose-finding trial evaluating the effect and safety of once-weekly treatment of somapacitan compared to daily Norditropin® in children with short stature born small for gestational age with no catch-up growth by 2 years of age or older

Conditions

SGA - small for gestational age children

Brief summary

Endpoint title: Height velocity (HV) Time frame: From baseline (week 0) to visit 6 (week 26) Unit: cm/year

Detailed description

Effect Endpoint title: Change in bone age Time frame: From baseline (week 0) to visit 8 (week 52) Unit: Years, Effect Endpoint title: Change in height SDS Time frame: From baseline (week 0) to visit 6 (week 26) Unit: -10 to +10, Effect Endpoint title: Change in Height velocity SDS Time frame: From baseline (week 0) to visit 6 (week 26) Unit: -10 to +10, Safety Endpoint title: Change in fasting plasma glucose Time frame: From screening (visit 1) to visit 6 (week 26) Unit: mmol/l, Safety Endpoint title: Change in homeostatic model assessment (HOMA) Time frame: From screening (visit 1) to visit 6 (week 26) Unit: %, Safety Endpoint title: Change in Glycated haemoglobin (HbA1c) Time frame: From screening (visit 1) to visit 6 (week 26) Unit: % point, Pharmacodynamics Endpoint title: Change in IGF-I SDS Time frame: From baseline (week 0) to visit 6 (week 26) Unit: -10 to +10, Pharmacodynamics Endpoint title: Change in IGFBP-3 SDS Time frame: From baseline (week 0) to visit 6 (week 26) Unit: -10 to +10

Related papers

No related papers found yet.

Interventions

DRUGNorditropin FlexPro

DRUGinjektionsvæske

DRUGopløsning i fyldt pen

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

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

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

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Endpoint title: Height velocity (HV) Time frame: From baseline (week 0) to visit 6 (week 26) Unit: cm/year	—

Secondary

Measure	Time frame
Effect Endpoint title: Change in bone age Time frame: From baseline (week 0) to visit 8 (week 52) Unit: Years, Effect Endpoint title: Change in height SDS Time frame: From baseline (week 0) to visit 6 (week 26) Unit: -10 to +10, Effect Endpoint title: Change in Height velocity SDS Time frame: From baseline (week 0) to visit 6 (week 26) Unit: -10 to +10, Safety Endpoint title: Change in fasting plasma glucose Time frame: From screening (visit 1) to visit 6 (week 26) Unit: mmol/l, Safety Endpoint title: Change in homeostatic model assessment (HOMA) Time frame: From screening (visit 1) to visit 6 (week 26) Unit: %, Safety Endpoint title: Change in Glycated haemoglobin (HbA1c) Time frame: From screening (visit 1) to visit 6 (week 26) Unit: % point, Pharmacodynamics Endpoint title: Change in IGF-I SDS Time frame: From baseline (week 0) to visit 6 (week 26) Unit: -10 to +10, Pharmacodynamics Endpoint title: Change in IGFBP-3 SDS Time frame: From baseline (week 0) to visit 6 (week 26) Unit: -	—

Measure

Time frame

Effect Endpoint title: Change in bone age Time frame: From baseline (week 0) to visit 8 (week 52) Unit: Years, Effect Endpoint title: Change in height SDS Time frame: From baseline (week 0) to visit 6 (week 26) Unit: -10 to +10, Effect Endpoint title: Change in Height velocity SDS Time frame: From baseline (week 0) to visit 6 (week 26) Unit: -10 to +10, Safety Endpoint title: Change in fasting plasma glucose Time frame: From screening (visit 1) to visit 6 (week 26) Unit: mmol/l, Safety Endpoint title: Change in homeostatic model assessment (HOMA) Time frame: From screening (visit 1) to visit 6 (week 26) Unit: %, Safety Endpoint title: Change in Glycated haemoglobin (HbA1c) Time frame: From screening (visit 1) to visit 6 (week 26) Unit: % point, Pharmacodynamics Endpoint title: Change in IGF-I SDS Time frame: From baseline (week 0) to visit 6 (week 26) Unit: -10 to +10, Pharmacodynamics Endpoint title: Change in IGFBP-3 SDS Time frame: From baseline (week 0) to visit 6 (week 26) Unit: -

—

Countries

Austria, France, Hungary, Italy, Latvia

Outcome results

None listed