GB06 Phase III Trial for Pediatric Growth Hormone Deficiency

This study aims to evaluate the efficacy and safety of GB06 (a biosimilar of Norditropin®FlexProTM from Novo Nordisk) for the treatment of growth disorders caused by growth hormone deficiency (GHD) in children. It aims to determine whether the annual height velocity (an index of height growth rate) in children diagnosed with GHD after 52 weeks of GB06 intervention is comparable to that of Norditropin®FlexProTM. To achieve this, the participants will administer GB06 or Norditropin®FlexProTM at 0.035mg/kg/day for 52 consecutive weeks.

NCT Number	NCT07553351
Lead Sponsor	Kexing Biopharm Co., Ltd.
Conditions	Growth Hormone Deficiency (GHD), Growth Hormone Deficiency in Children, Growth Hormone Deficiency, Pediatric
Enrollment	192 participants
Start Date	2026-06-06
Primary Completion	2028-07-25 (estimated)
Study Completion	2028-10-24 (estimated)
Updated on ClinicalTrials.gov	2026-06-10