Effective GH Replacement with Somapacitan in Children with GHD: REAL4 2-year Results and after Switch from Daily GH.

ABSTRACT:

Context

Somapacitan is a long-acting GH derivative for treatment of GH deficiency (GHD).

Objective

Evaluate the efficacy and tolerability of somapacitan in children with GHD after 2 years of treatment and after switch from daily GH.

Design

A randomised, multi-national, open-labelled, controlled parallel group phase 3 trial, comprising a 52-week main phase and 3-year safety extension (NCT03811535).

Setting

Eighty-five sites across 20 countries.

Patients

200 treatment-naïve pre-pubertal patients were randomized and exposed. 194 completed the 2-year period.

Interventions

Patients were randomized 2:1 to somapacitan (0.16 mg/kg/week) or daily GH (0.034 mg/kg/day) during the first year, after which all patients received somapacitan 0.16 mg/kg/week.

M

SUBMITTER: Miller BS 

PROVIDER: S-EPMC10655534 | biostudies-literature | 2023 Jul

REPOSITORIES: biostudies-literature