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A Multicenter, 12-Month, Randomized, Double Blind, Placebo-Controlled Phase 3 Efficacy and Safety Study of Daily Oral LUM-201 in Naïve-to-Treatment, Prepubertal Children With Growth Hormone Deficiency (GHD)

Trial Profile

A Multicenter, 12-Month, Randomized, Double Blind, Placebo-Controlled Phase 3 Efficacy and Safety Study of Daily Oral LUM-201 in Naïve-to-Treatment, Prepubertal Children With Growth Hormone Deficiency (GHD)

Status: Not yet recruiting
Phase of Trial: Phase III

Latest Information Update: 05 May 2025

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At a glance

  • Drugs Ibutamoren (Primary)
  • Indications Somatotropin deficiency
  • Focus Registrational; Therapeutic Use
  • Sponsors Lumos Pharma

Most Recent Events

  • 29 Apr 2025 Status changed from planning to not yet recruiting.
  • 23 Oct 2024 According to a Lumos Pharma media release, company announced that the FDA are aligned on the Company's final Phase 3 trial design and This trial will be conducted at approximately 80 global sites.
  • 01 Aug 2024 According to a Lumos Pharma media release, company expects to be in a position to initiate this trial in the second quarter of 2025

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