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Somapacitan vs Norditropin in Children With Growth Hormone Deficiency

NCT03811535Phase 3

Key facts

Status: Completed
Start: May 2019
Primary completion: Nov 2021
Countries: 26
Sponsor: Novo Nordisk
Modality: Recombinant Proteins and Enzymes

Drugs: somapacitan
Conditions: growth hormone deficiency (GHD)

Overview

Phase 3, randomised, open-label trial of somapacitan in growth hormone deficiency (GHD) (2 arms), sponsored by Novo Nordisk. Primary endpoint: Height Velocity at 52 weeks. Started May 2019; status: completed.

Design

2 arms

Study design: RandomizedOpen-label

Somapacitan weekly
Somapacitan administered subcutaneously once weekly
Norditropin® daily
Norditropin administered subcutaneously once daily

Who it enrols

Prepubertal children (boys <11 years, girls <10 years) with confirmed growth hormone deficiency, impaired height and height velocity, and no prior exposure to growth hormone therapy or IGF-I treatment.

Endpoints

Primary

Height Velocity52 weeks

Secondary

Change in Bone Age52 weeks
Height Standard Deviation Score52 weeks
Height Velocity Standard Deviation Score52 weeks
Fasting Plasma Glucose208 weeks
Homeostatic Model Assessment Steady State Beta Cell Function208 weeks
Homeostatic Model Assessment Insulin Resistance208 weeks
Glycated Haemoglobin208 weeks
Insulin-like Growth Factor I Standard Deviation Score208 weeks

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