Effective GH Replacement With Once-weekly Somapacitan vs Daily GH in Children with GHD: 3-year Results From REAL 3.

ABSTRACT:

Context

Current GH therapy requires daily injections, which can be burdensome. Somapacitan is a long-acting GH derivative in development for treatment of GH deficiency (GHD).

Objective

Evaluate the efficacy, safety, and tolerability of once-weekly somapacitan after 3 years of treatment.

Design

A multicenter, randomized, controlled, phase 2 study comparing somapacitan and once-daily GH for 156 weeks (NCT02616562).

Setting

Twenty-nine sites in 11 countries.

Patients

Fifty-nine children with GHD randomized (1:1:1:1) and exposed to treatment. Fifty-three children completed the 3-year period.

Interventions

Patients received somapacitan (0.04 [n = 14], 0.08 [n = 15], or 0.16 [n = 14] mg/kg/wk) or daily GH (n = 14) (0.034 mg/kg/d, equivalent to 0.238 mg/

SUBMITTER: Savendahl L 

PROVIDER: S-EPMC9016428 | biostudies-literature | 2022 Apr

REPOSITORIES: biostudies-literature