Pediatric endocrinology

Children with Growth Hormone Deficiency Treated with Lonapegsomatropin Demonstrated Sustained Height Improvements for up to 6 Years: enliGHten Trial Final Results

Horm Res PaediatrPublished Open-label extension trial

Authors' conclusion

Treatment of pediatric GHD with lonapegsomatropin in the enliGHten trial provided robust growth outcomes and maintained a safety profile comparable to that of daily GH in a population with a broad range of pubertal statuses. </p>.

Study context

Population
Children with growth hormone deficiency (GHD) who previously participated in a phase 3 lonapegsomatropin trial (heiGHt or fliGHt)
Outcome
Height SDS
Follow-up
Year 4
Methodological detailsinternational, phase 3, 63 sites (15 countries)
  • International
  • Phase 3
  • 63 sites (15 countries)

Main finding

As reported in the abstract

Lonapegsomatropin

−0.39

mean

Further findings

OutcomeValues
Met or exceeded average parental height SDS at last visit, among participants completing treatmentLonapegsomatropin 59.3%
  • Met or exceeded average parental height standard deviation score (SDS) at last visit, among participants completing treatment: 81 completed treatment for pediatric GHD

Weekly average IGF-1 SDS

Mean weekly average IGF-1 remained within 0-2 SDS throughout the trial

Growth during puberty and dose

Growth maintained throughout pubertal development; dose remained stable

Safety

Adverse events

AEs mostly mild or moderate, consistent with prior reports of daily somatropin; no evidence of accelerated skeletal maturation or safety signals associated with anti-drug antibodies

Original publication

Children with Growth Hormone Deficiency Treated with Lonapegsomatropin Demonstrated Sustained Height Improvements for up to 6 Years: enliGHten Trial Final Results. Horm Res Paediatr. Published 6 March 2025. doi:10.1159/000545064

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