GB06 Phase III Trial for Pediatric Growth Hormone Deficiency

NCT07553351 | Not Yet Recruiting Phase 3

• 1 other identifier: KXZY-GB06-301
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief 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 in Children; Growth Hormone Deficiency (GHD); Growth Hormone Deficiency, Pediatric

Keywords

Growth Hormone; Growth Hormone Deficiency; Annual Height Velocity; Insulin-like Growth Factor-1; Bone Age; GB06

Outcome Measures

Primary Outcomes (1)

• Annual height velocity (AHV) at week 52.

  From enrollment to the end of treatment at 52 weeks

Secondary Outcomes (10)

• AHV at weeks 5, 13, 26, and 39 and their changes from baseline

  From enrollment to treatment at 39 weeks

• AHV standard deviation score (SDS) at weeks 5, 13, 26, 39, and 52, and their change from baseline

  From enrollment to the end of treatment at 52 weeks

• Change in height SDS for chronological age (Ht SDS CA) at weeks 5, 13, 26, 39, and 52, and comparison with baseline

  From enrollment to the end of treatment at 52 weeks

• Bone age at week 52

  From enrollment to the end of treatment at 52 weeks

• Change from baseline in Bone Age Height SDS (Ht SDS BA) at Week 52

  From enrollment to the end of treatment at 52 weeks

Study Arms (2)

GB06

EXPERIMENTAL

Drug: GB06

Norditropin®FlexProTM

ACTIVE COMPARATOR

Drug: Norditropin®FlexProTM

Interventions

GB06 DRUG

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

GB06

Norditropin®FlexProTM DRUG

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

Norditropin®FlexProTM

Eligibility Criteria

• Age: 3 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The legal guardian of the participant understands and signs the written informed consent form (ICF); Participants over 8 years old are also required to sign the ICF, and if they are under 8 years old but can express consent, their opinions should be clearly documented.
• Age ≥ 3 years old and ≤ 11 years old (boys) or ≤ 10 years old (girls);
• Height below two standard deviations (SD) of the average height of children of the same age and gender;
• Annual height velocity (AHV) \<5cm/year, based on height within 6 months to 18 months before screening;
• Body mass index (BMI) within the average ±2 SD of healthy children of the same age and gender;
• Short stature with normal intellectual development;
• Tanner stage I (testicular volume \<4ml for boys, no palpable breast gland tissue for girls);
• IGF-1 level below the reference value corresponding to -1SDS for children of the same age and gender;
• Bone age lags behind the chronological age;
• Diagnosis as GHD by GH stimulation test with two different drugs within 12 months before screening, and the peak GH level ≤ 10.0ng/ml;
• A standard karyotype of 46, XX for girls.

You may not qualify if:

• Known allergy to ingredients of the study drug;
• Previous treatment with recombinant human growth hormone (rhGH) or IGF-1 or combination with other treatments that may affect growth;
• Administration of any investigational drug within 3 months before screening or participation in another clinical trial before randomization;
• Small for gestational age;
• Epiphyseal closure;
• Congenital intracranial hypertension;
• Slipped capital femoral epiphysis;
• GHD secondary to another pituitary hormone deficiency;
• Previous history or current diagnosis of malignancy (including intracranial tumors); Intracranial tumors must be confirmed by magnetic resonance imaging or computed tomography;
• History of fundus lesions (optic nerve papilledema lesions);
• Diagnosis of diabetes, or fasting blood glucose ≥ 7.0 mmol/L or hemoglobin A1c (HbA1c) ≥ 6.5%;
• Administration of systemic corticosteroid therapy consecutively for more than 2 weeks within 3 months before screening;
• Expected requirement to inhale budesonide \>400μg/day or equivalent dose of inhaled glucocorticoid therapy for more than four consecutive weeks during the trial;
• Other growth abnormalities or abnormalities that may affect height, including but not limited to: chromosomal aneuploidy, Turner syndrome, Lehren's syndrome, Noonan syndrome, Prader-Willi syndrome, SHOX-1 gene abnormality, GH receptor deletion, or other significant genetic mutations causing short stature; Significant spinal abnormalities, including but not limited to scoliosis, kyphosis, and spina bifida; Congenital anomalies (resulting in skeletal abnormalities), including but not limited to Russell-Silver syndrome and bone dysplasia; Family history of bone dysplasia;
• Other clinically significant abnormalities that may affect growth or assessment of growth capacity, including but not limited to hepatic and renal dysfunction \[e.g., alanine aminotransferase (ALT)\> 1.5 times the upper limit of normal, creatinine (Cr) \>upper limit of normal value\], malnutrition, severe cardiopulmonary and hematological diseases, systemic infection, immunodeficiency, mental abnormalities, and other congenital malformations;

Sponsors & Collaborators

• Kexing Biopharm Co., Ltd.: lead

Study Sites (1)

Chengdu Women and Children Central Hospital

Chengdu, Sichuan, 610074, China

Location

MeSH Terms

Conditions

Dwarfism, Pituitary

Condition Hierarchy (Ancestors)

Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Hypopituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors who measure the height of participants will be blinded to the grouping to reduce bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: April 28, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): July 25, 2028
• Study Completion (Estimated): October 24, 2028
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)