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ABSTRACT: Introduction
This international, Phase 3, open-label extension trial evaluated the long-term safety and efficacy of once-weekly lonapegsomatropin in children with growth hormone deficiency (GHD).Methods
Conducted across 63 sites (15 countries), the enliGHten trial enrolled children with GHD who previously participated in a Phase 3 lonapegsomatropin trial (heiGHt or fliGHt). Participants received subcutaneous injections of lonapegsomatropin dosed at 0.24 mg hGH/kg/week. Safety was monitored through adverse events, local tolerability, hormone levels, and metabolic parameters. Efficacy was evaluated through annualized height velocity (AHV), change in height standard deviation score (SDS), and IGF-1 SDS.Results
Lonapegsomatropin demonstrated sustained efficacy with mean
SUBMITTER: Maniatis AK
PROVIDER: S-EPMC12060840 | biostudies-literature | 2025 Mar
REPOSITORIES: biostudies-literature