Weekly Somapacitan is Effective and Well Tolerated in Children With GH Deficiency: The Randomized Phase 3 REAL4 Trial.

ABSTRACT:

Context

Somapacitan, a once-weekly reversible albumin-binding GH derivative, is evaluated in children with GH deficiency (GHD).

Objective

To demonstrate efficacy and safety of somapacitan vs daily GH.

Methods

REAL4 is a randomised, multinational, open-labeled, active-controlled parallel group phase 3 trial, comprising a 52-week main trial and 3-year extension (NCT03811535).

Setting

Eighty-six sites across 20 countries.

Patients

200 treatment-naïve patients were randomized and exposed.

Interventions

Patients were randomized 2:1 to somapacitan (0.16 mg/kg/wk) or daily GH (Norditropin; 0.034 mg/kg/d), administered subcutaneously.

Main outcome measures

The primary endpoint was annualized height velocity (HV; cm/y) at week 52. Additional assessm

SUBMITTER: Miller BS 

PROVIDER: S-EPMC9693810 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature