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GB06 Phase III Trial for Pediatric Growth Hormone Deficiency

NCT07553351 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2026-06-10

No results posted yet for this study

Summary

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.

Conditions

  • Growth Hormone Deficiency (GHD)
  • Growth Hormone Deficiency in Children
  • Growth Hormone Deficiency, Pediatric

Interventions

DRUG

GB06

GB06 0.035mg/kg/day by subcutaneous injection for 52 weeks

DRUG

Norditropin®FlexProTM

Norditropin®FlexProTM 0.035mg/kg/day by subcutaneous injection for 52 weeks

Sponsors & Collaborators

  • Kexing Biopharm Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-06
Primary Completion
2028-07-25
Completion
2028-10-24

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07553351 on ClinicalTrials.gov