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A Multicenter, Phase 3, Randomized, Open-label, Active-controlled, Parallel-group Trial Investigating the Safety, Tolerability, and Efficacy of TransCon hGH Administered Once a Week Versus Standard Daily hGH Replacement Therapy Over 52 Weeks in Prepubertal Children With Growth Hormone Deficiency (GHD)

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Trial Profile

A Multicenter, Phase 3, Randomized, Open-label, Active-controlled, Parallel-group Trial Investigating the Safety, Tolerability, and Efficacy of TransCon hGH Administered Once a Week Versus Standard Daily hGH Replacement Therapy Over 52 Weeks in Prepubertal Children With Growth Hormone Deficiency (GHD)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Jun 2025

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At a glance

  • Drugs Lonapegsomatropin (Primary) ; Somatropin
  • Indications Somatotropin deficiency
  • Focus Registrational; Therapeutic Use
  • Acronyms heiGHT
  • Sponsors Ascendis Pharma

Most Recent Events

  • 29 May 2025 According to an Ascendis Pharma media release, company Therapeutic Goods Administration (TGA) has approved SKYTROFA as a treatment for "growth failure in children and adolescents aged from 3 years up to 18 years due to insufficient endogenous growth hormone secretion based on the results of heiGHt, fliGHt and enlighten trials.
  • 18 Jun 2023 Results assessing explores IGF-1 levels, dose adjustments, and height outcomes by Tanner Stage in 3 studies heiGHt (treatment-naive trial), fliGHt (switch trial), and enliGHten (open-label extension trial), presented at the 105th Annual Meeting of the Endocrine Society.
  • 13 Jun 2023 According to an Ascendis Pharma media release, the poster including the subanalysis of tanner stage in children and adolescents with growth hormone deficiency treated with lonapegsomatropin will be presented at ENDO 2023, the annual meeting of the Endocrine Society being held June 15-18 in Chicago.

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