Growth Hormone Deficiency in ChildrenPhase 2/3NCT07126288

Evaluating the Efficacy and Safety of GB08 Injection in Pediatric Patients With Growth Hormone Deficiency

A Phase 2/3 study testing GB08 and Norditropin NordiFlex in people with Growth Hormone Deficiency in Children and Growth Hormone Deficiency (GHD), run by Shenzhen Kexing Pharmaceutical Co., Ltd. at 16 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

This study aims to evaluate the efficacy and safety of GB08 injection compared to Norditropin NordiFlex in pediatric patients with growth hormone deficiency (PGHD). It seeks to resolve the following questions: 1: Does GB08 injection demonstrate comparable efficacy in treating PGHD at 24 weeks compared to Norditropin… Read more about this study

Who is it for?: Ages 3 to 11 years
Conditions the study is for: Growth Hormone Deficiency in Children, Growth Hormone Deficiency (GHD), Growth Hormone
What is being tested?: GB08 and Norditropin NordiFlex
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 268 participants
Where: 16 sitesChina
Study dates: 31 Aug 2025to 23 Dec 2028
Phase: Phase 2/3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 3 to 11 years
All sexes
No healthy volunteers
Child

Who may be able to join

1. Diagnosed with Growth Hormone Deficiency (GHD) based on medical history, clinical symptoms and signs, GH stimulation tests, and imaging studies. The participant must meet the following:
Absolute height 2 standard deviations (SD) below the mean height of children of the same age and sex, according to the standardized growth curves for children and adolescents in China (0-18 years old) published in 2009.
Annualized height velocity (AHV) ≤ 5.0 cm/year, calculated from measurement of 6 to 18 months before screening.
GH peak ≤ 10 ng/ml proved by two different GH stimulation tests within a year before screening.
Bone age lagging at least 1 year behind actual age (bone age assessment within the past 6 months before screening), with girls < 10 years old and boys < 11 years old.
2. Aging > 3 years and ≤ 10 years (girls) or ≤ 11 years (boys) based on birth date; Tanner stage I (testicular volume < 4 ml for boys and no palpable breast tissue for girls) 3. Uniform short stature with normal intellectual development. 4. IGF-1 levels below the mean for children and adolescents of the same age and sex, at least 1 SD below (IGF-1 SDS ≤ -1.0).

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5. Body mass index (BMI) within ±2 SD of the mean BMI for children and adolescents of the same age and sex.
6. For subjects with GHD as part of multiple pituitary hormone deficiencies, must be stable for ≥1 month, as determined by the investigator.
7. Guardians understand and sign the Informed Consent Form (ICF). If the participant is ≥8 years old, they must also sign the ICF. For participants <8 years old who can express consent, their consent must be recorded.

Who cannot join

History of systematic growth-promoting therapy, including growth hormone and sex hormones.
Severe allergic constitution or known allergy to growth hormone or its excipients, such as mannitol, lysine, or sodium chloride.
Closed epiphyses.
Other types of growth disorders such as idiopathic short stature, Turner syndrome, Noonan syndrome, Prader-Willi syndrome, and Russell-Silver syndrome.
Short stature due to other causes, such as intrauterine growth restriction, familial short stature, thyroid hormone deficiency, adrenal insufficiency, antidiuretic hormone deficiency, celiac disease, rickets, psychological factors, chronic kidney disease, infections, or trauma.
Any clinically significant abnormalities that may affect growth or growth assessment; subjects with liver or kidney dysfunction (ALT > 1.5 times upper limit of normal, creatinine > upper limit of normal), chronic diseases (malnutrition, fasting blood glucose ≥ 126 mg/dL or HbA1c ≥ 6.5%), diabetes, severe cardiac, pulmonary, hematological, or systemic infections, immunodeficiency, psychiatric disorders, or congenital malformations.

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Infectious diseases, such as hepatitis B, hepatitis C, AIDS, syphilis, or tuberculosis (HBV surface antigen-positive subjects must undergo HBV DNA testing; HCV antibody-positive subjects must undergo HCV RNA testing; if HBV DNA or HCV RNA > detection limit, they are excluded).
Use of corticosteroids or other steroids within the past 12 months, such as long-term steroid use for asthma.
History of pituitary or hypothalamic tumors, or other intracranial tumors on MRI; history of leukemia, lymphoma, or other malignancies.
History of radiation therapy or chemotherapy.
Congenital intracranial hypertension.
Femoral head slipped epiphysis (SCFE).
Spinal scoliosis > 15°.
Participation in any other drug clinical trial within the past 3 months (as a subject).
Other factors deemed unsuitable for participation in the study by the investigator.

Trial locations and contacts

16 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Yanqing Lin contact

86-0755-23018589

linyanqing@kexing.com

Jinhai Lin contact

86-13760806104

linjinhai@kexing.com

City, postcode or hospital

16 sites in 1 country

China16 sites

The First Hospital of Jilin University
Changchun, Jilin, 130021
Yining Zhang
Chengdu Women's and Children's Central Hospital
Chengdu, Sichuan, 610017
Fang Tang
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310014
Qin Zhou
Children's Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310051
Junfen Fu
Linyi Maternal and Child Health Hospital
Linyi, Shandong, 276000
Xiuying Ge
Meishan People's Hospital
Meishan, Sichuan, 620010
Yangfan Fei
Jiangxi Children's Hospital
Nanchang, Jiangxi, 330006
Yu Yang
Nanyang Central Hospital
Nanyang, Henan, 473000
Na Xu
The First Affiliated Hospital of Nanyang Medical College
Nanyang, Henan, 473000
Xiaoxia Shi
Ningbo Women's and Children's Hospital
Ningbo, Zhejiang, 315010
Shuxia Ding
Pingxiang Maternal and Child Health Hospital
Pingxiang, Jiangxi, 337000
Li Zhou
Suzhou University Children's Hospital
Suzhou, Jiangsu, 215000
Rongrong Xie
Wuhan Children's Hospital
Wuhan, Hubei, 430016
Hui Yao
Xiamen Maternal and Child Health Hospital
Xiamen, Fujian, 361000
Xiaoqing Yang
The Third Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, 453003
Jinfen Han
The Second People's Hospital of Yibin
Yibin, Sichuan, 644000
Lan Yao

Other trials in China

About this study

Official title: A Phase II/III, Seamless, Multicenter, Randomized, Open-Label, Positive-Comparator Controlled Clinical Trial to Evaluate the Efficacy and Safety of GB08 Injection in Pediatric Patients With Growth Hormone Deficiency

1: Does GB08 injection demonstrate comparable efficacy in treating PGHD at 24 weeks compared to Norditropin NordiFlex?
2: Which dose (0.4 mg/kg, 0.8 mg/kg, and 1.2 mg/kg) of GB08 injection best balances efficacy and safety in treating PGHD at 24 weeks?
3: Does GB08 injection maintain its efficacy in treating PGHD at 52 weeks compared to Norditropin NordiFlex? To achieve these, GB08 injection will be compared to Norditropin NordiFlex to see if it provides a more effective or safer treatment option for PGHD.

This is a Phase II/III, Seamless, Multicenter, Randomized, Open-Label, Positive-Comparator Controlled Clinical Trial with two stages. Stage 1 answers questions #1 and #2 by comparing the efficacy and safety of GB08 injection and Norditropin NordiFlex intervention among PGHD at 24 weeks. It involves four groups (n=16 each): GB08 0.4 mg/kg, GB08 0.8 mg/kg, GB08 1.2 mg/kg, and Norditropin NordiFlex 0.035 mg/kg. GB08 and Norditropin NordiFlex will be administered once weekly and once daily, respectively. The primary outcome measurement is annualized height velocity (AHV) at 24 weeks. Other measurements include growth hormone levels, safety parameters, immunogenicity markers, and pharmacokinetic/pharmacodynamic profiles.

The optimal GB08 dose will be further investigated in Stage 2, which answers question #3. At this stage, PGHD patients will randomly receive either GB08 injection or Norditropin NordiFlex intervention for 52 weeks (n=102 for each). After that, the efficacy and safety of GB08 will also be detected.

Read the detailed description

This is a multicenter, randomized, open-label, positive-controlled Phase II/III seamless design clinical study evaluating the efficacy and safety of GB08 injection in pediatric patients with growth hormone deficiency (PGHD). It aims to compare the efficacy and safety of GB08 injection with Norditropin NordiFlex in PGHD patients, thereby benefiting this population. This study involves two parts: Phase II and Phase III.

Phase II: Identifying the Optimal Dose This part assesses the efficacy and safety of three doses of GB08 in treating PGHD to recommend the optimal dose for the phase III.

Eligible patients with PGHD will be randomly divided into four groups (n=16 per group) and stratified by GH peak value (≤5 μg/L and >5 μg/L). They will receive GB08 0.4 mg/kg, GB08 0.8 mg/kg, GB08 1.2 mg/kg, or Norditropin NordiFlex 0.035 mg/kg (positive control) treatment for 24 weeks with another 28 weeks of follow-up. GB08 and Norditropin NordiFlex therapy will be provided once weekly and once daily, respectively. All participants will have blood samples collected for pharmacokinetics (GB08 groups only), pharmacodynamics, immunogenicity, and safety and efficacy assessments, as well as records of concomitant medications/treatments and adverse events. The primary outcome measurement is the annualized height velocity (AHV) at 24 weeks among the four groups. The optimal GB08 dose will be identified based on the 24-week data.

Phase III: The 52-week efficacy and safety of GB08 injection compared to Norditropin NordiFlex This part aims to evaluate the efficacy of GB08 injection compared to Norditropin NordiFlex in PGHD patients at 52 weeks.

It contains a treatment group (GB08 injection) and a control group (Norditropin NordiFlex), each with 102 participants. Accordingly, they will receive GB08 or Norditropin NordiFlex intervention for 52 weeks. The dose of GB08 will be determined by Phase II. Stratified randomization will be based on age (<6 years vs. ≥6 years), gender (male vs. female), and GH peak value (≤ 5 ug/L, 5-7 ug/L, >7 ug/L). The treatment period will last for 52 weeks with a 2-week follow-up. The primary endpoint measurement is the efficacy of GB08 injection at the 52nd week compared to Norditropin NordiFlex.

Conditions: Growth Hormone Deficiency in Children, Growth Hormone Deficiency (GHD), Growth Hormone
Being tested: GB08, Norditropin NordiFlex
Keywords: growth hormone deficiency, annualized height velocity, growth hormone, clinical trial, GB08 injection
Medical subject headings: Dwarfism, Pituitary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GB08Drug
In Phase II trial, eligible PGHD patients will receive GB08 0.4mg/kg, 0.8mg/kg, or 1.2mg/kg subcutaneous injection, once a week for 24 weeks.
In Phase III trial, the individuals will receive GB08 subcutaneous injection, once a week for 52 weeks. The dose of GB08 at this stage will be determined by the outcomes of Phase II.
Norditropin NordiFlexDrug
Norditropin NordiFlex 0.035 mg/kg subcutaneous injection, daily, for 24 weeks (Phase II) or 52 weeks (Phase III)

Study groups in NCT07126288
Study group	Role	What they receive
PhaseII GB08 0.4 mg/kg	Experimental	GB08 0.4mg/kg subcutaneous injection, once a week for 24 weeks Receives: Drug: GB08
PhaseII GB08 0.8 mg/kg	Experimental	GB08 0.8mg/kg subcutaneous injection, once a week for 24 weeks Receives: Drug: GB08
PhaseII GB08 1.2 mg/kg	Experimental	GB08 1.2mg/kg subcutaneous injection, once a week for 24 weeks Receives: Drug: GB08
PhaseII Norditropin NordiFlex	Active comparator	Norditropin NordiFlex 0.035 mg/kg subcutaneous injection, daily, for 24 weeks Receives: Drug: Norditropin NordiFlex
PhaseIII GB08	Experimental	GB08 subcutaneous injection (The dose will be determined by data from PhaseII), once a week for 52 weeks Receives: Drug: GB08
PhaseIII Norditropin NordiFlex	Active comparator	Norditropin NordiFlex 0.035 mg/kg subcutaneous injection, daily, for 52 weeks Receives: Drug: Norditropin NordiFlex

What is being measured

The primary outcome is the main question the study is designed to answer.

PhaseII-Comparison of annualized height velocity at 24 weeks
Comparison of annualized height velocity of PGHD patients receiving 24-week GB08 and Norditropin NordiFlex treatment
Measured: From enrollment to end of treatment at 24 weeks
PhaseIII-Comparison of annualized height velocity at week 52
Comparison of annualized height velocity between PGHD patients receiving GB08 and Norditropin NordiFlex at 52 weeks
Measured: From enrollment to end of treatment at week 52

Secondary outcomes (24)

PhaseII-annualized height velocity at weeks 4, 12, 36, 48, 52
Measured: From enrollment to weeks 4, 12, 36, 48, 52
PhaseII-Standard deviation (SD) scores of AHV of GB08 injection and Norditropin NordiFlex at baseline, and at weeks 4, 12, 36, 48, 52
Measured: From enrollment to weeks 4, 12, 36, 48, 52
PhaseII-Standard deviation of actual height SDS (Ht SDS CA) of GB08 injection and Norditropin NordiFlex at weeks 4, 12, 24, 36, 48, 52
Measured: From enrollment to weeks 4, 12, 24, 36, 48, 52
PhaseII-Standard deviation of bone age (BA) SDS (Ht SDS BA) of GB08 injection and Norditropin NordiFlex at week 24 and 52
Measured: From enrollment to weeks 24 and 52
PhaseII-Tanner stage changes at baseline and at weeks 12, 24, 52
Measured: From enrollment to weeks 12, 24, and 52
PhaseII-Body weight and BMI changes at baseline and at weeks 2, 4, 8, 12, 24, 52
Measured: From enrollment to weeks 2, 4, 8, 12, 24, and 52
PhaseII-Ratio of BA to CA at baseline and at weeks 24, 52
Measured: From enrollment to weeks 24 and 52
PhaseII-Serum IGF-1, IGF-1 SDS, and IGFBP-3 levels, and their changes from baseline at weeks 2, 4, 8, 12, 24, 36, 48, 52
Measured: From enrollment to weeks 2, 4, 8, 12, 24, 36, 48, and 52
PhaseII-Serum IGF-1, IGF-1 SDS, and IGFBP-3 levels, and their changes from baseline at 48 hours post-dose of GB08 injection at weeks 2, 4, 8, 12, 24, 36, 48, 52
Measured: From enrollment to weeks 2, 4, 8, 12, 24, 36, 48, and 52
PhaseIII-AHV of GB08 injection and Norditropin NordiFlex at baseline, and at weeks 4, 12, 24, 36, 48, 52
Measured: From enrollment to weeks 4, 12, 24, 36, 48, and 52
PhaseIII-Standard deviation (SD) scores of AHV of GB08 injection and Norditropin NordiFlex at baseline, and at weeks 4, 12, 24, 36, 48, 52
Measured: From enrollment to weeks 4, 12, 24, 36, 48, and 52
PhaseIII-Standard deviation of actual height SDS (Ht SDS CA) of GB08 injection and Norditropin NordiFlex at weeks 4, 12, 24, 36, 48, 52
Measured: From enrollment to weeks 4, 12, 24, 36, 48, and 52
PhaseIII-Standard deviation of bone age (BA) SDS (Ht SDS BA) of GB08 injection and Norditropin NordiFlex at week 52
Measured: From enrollment to week 52
PhaseIII-Tanner stage changes at baseline and at weeks 12, 24, 52
Measured: From enrollment to weeks 12, 24, and 52
PhaseIII-Body weight and BMI changes at baseline and at weeks 2, 4, 8, 12, 24, 52
Measured: From enrollment to weeks 2, 4, 8, 12, 24, and 52
PhaseIII-Serum IGF-1, IGF-1 SDS, and IGFBP-3 levels, and their changes from baseline at weeks 2, 4, 8, 12, 24, 36, 48, 52
Measured: From enrollment to weeks 2, 4, 8, 12, 24, 36, 48, and 52
PhaseIII-Serum IGF-1, IGF-1 SDS, and IGFBP-3 levels, and their changes from baseline at 48 hours post-dose of GB08 injection at weeks 2, 4, 8, 12, 24, 36, 48, 52
Measured: From enrollment to weeks 2, 4, 8, 12, 24, 36, 48, and 52
PhaseII-Safety Evaluation Endpoints
Adverse events (AEs), vital signs, ECG, physical examination, abnormal clinical laboratory parameters (including but not limited to complete blood count, blood biochemistry, urinalysis, thyroid function, fasting insulin, prolactin, HbA1c, fasting serum cortisol), and injection site examination.
Measured: weeks 2, 4, 8, 12, 24, 36, 48, 52.
PhaseII-Immunogenicity Evaluation Endpoints
Blood samples will be collected at baseline and at weeks 12, 24, 36, 52 to determine the presence of anti-drug antibodies (ADA). If ADA is positive, neutralizing antibody and titer analysis will be performed. If ADA-positive subjects are needed for safety and efficacy analysis, additional ADA, neutralizing antibody, and titer testing may be conducted.
Measured: weeks 12, 24, 36, 52
PhaseII-Pharmacokinetics Evaluation Endpoints
PK parameters: maximum concentration (Cmax), area under the curve from time 0 to the last measurable concentration (AUC0-t), area under the curve from time 0 to infinity (AUC0-inf), time to peak concentration (Tmax), elimination rate constant (λz), elimination half-life (t1/2), apparent volume of distribution (Vd/F), apparent clearance (CL/F), AUC0-inf extrapolated percentage (AUC_%Extrap).
Measured: weeks 2, 4, 8, 12, 24, 36, 48, 52.
PhaseII-Pharmacodynamics Evaluation Endpoints
Observed maximum effect (Emax), time to reach maximum effect (TEmax), area under the effect-time curve from time 0 to the last measurable time point (AUEC0-t), area under the effect-time curve from time 0 to 24 hours (AUEC0-24h), area under the effect-time curve from time 0 to 168 hours (AUEC0-168h).
Measured: time 0 to 168 hours
PhaseIII-Safety Evaluation Endpoints
Adverse events (AEs), vital signs, 12-lead ECG, physical examination, abnormal clinical laboratory parameters (including but not limited to complete blood count, blood biochemistry, urinalysis, thyroid function, fasting insulin, prolactin, HbA1c, fasting serum cortisol), and injection site examination.
Measured: weeks 2, 4, 8, 12, 24, 36, 48, 52
PhaseIII-Immunogenicity Evaluation Endpoints
Blood samples will be collected at baseline and at weeks 12, 24, 36, 52 to determine the presence of anti-drug antibodies (ADA). If ADA is positive, neutralizing antibody and titer analysis will be performed. If ADA-positive subjects are needed for safety and efficacy analysis, additional ADA, neutralizing antibody, and titer testing may be conducted.
Measured: weeks 12, 24, 36, 52
PhaseIII-Pharmacodynamics Evaluation Endpoints
GB08 injection and Norditropin NordiFlex concentrations of IGF-1 and IGFBP-3, relative changes from baseline, and percentage changes at baseline and at weeks 12, 24, 36, 52.
Measured: weeks 12, 24, 36, 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Aug 202523 Dec 2028

First posted17 Aug 2025
Study start31 Aug 2025 (estimated)
Primary completion15 Sep 2028 (estimated)
Study completion23 Dec 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Growth Hormone Deficiency in ChildrenStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Model description: Phase II/III seamless design clinical study
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 268 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07126288
Sponsor's protocol ID: KXZY-GB08-201
Status last verified: Aug 2025
First submitted: 10 Aug 2025
Last updated: 22 Aug 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Christiansen JS, Backeljauw PF, Bidlingmaier M, Biller BM, Boguszewski MC, Casanueva FF, Chanson P, Chatelain P, Choong CS, Clemmons DR, Cohen LE, Cohen P, Frystyk J, Grimberg A, Hasegawa Y, Haymond MW, Ho K, Hoffman AR, Holly JM, Horikawa R, Hoybye C, Jorgensen JO, Johannsson G, Juul A, Katznelson L, Kopchick JJ, Lee KO, Lee KW, Luo X, Melmed S, Miller BS, Misra M, Popovic V, Rosenfeld RG, Ross J, Ross RJ, Saenger P, Strasburger CJ, Thorner MO, Werner H, Yuen K. Growth Hormone Research Society perspective on the development of long-acting growth hormone preparations. Eur J Endocrinol. 2016 Jun;174(6):C1-8. doi: 10.1530/EJE-16-0111. Epub 2016 Mar 23.
PubMed 27009113
Rosenfeld RG, Bakker B. Compliance and persistence in pediatric and adult patients receiving growth hormone therapy. Endocr Pract. 2008 Mar;14(2):143-54. doi: 10.4158/EP.14.2.143.
PubMed 18308651
Allen DB, Backeljauw P, Bidlingmaier M, Biller BM, Boguszewski M, Burman P, Butler G, Chihara K, Christiansen J, Cianfarani S, Clayton P, Clemmons D, Cohen P, Darendeliler F, Deal C, Dunger D, Erfurth EM, Fuqua JS, Grimberg A, Haymond M, Higham C, Ho K, Hoffman AR, Hokken-Koelega A, Johannsson G, Juul A, Kopchick J, Lee P, Pollak M, Radovick S, Robison L, Rosenfeld R, Ross RJ, Savendahl L, Saenger P, Sorensen HT, Stochholm K, Strasburger C, Swerdlow A, Thorner M. GH safety workshop position paper: a critical appraisal of recombinant human GH therapy in children and adults. Eur J Endocrinol. 2016 Feb;174(2):P1-9. doi: 10.1530/EJE-15-0873. Epub 2015 Nov 12.
PubMed 26563978
Cook DM, Rose SR. A review of guidelines for use of growth hormone in pediatric and transition patients. Pituitary. 2012 Sep;15(3):301-10. doi: 10.1007/s11102-011-0372-6.
PubMed 22271255
Yuen KCJ, Biller BMK, Radovick S, Carmichael JD, Jasim S, Pantalone KM, Hoffman AR. AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY GUIDELINES FOR MANAGEMENT OF GROWTH HORMONE DEFICIENCY IN ADULTS AND PATIENTS TRANSITIONING FROM PEDIATRIC TO ADULT CARE. Endocr Pract. 2019 Nov;25(11):1191-1232. doi: 10.4158/GL-2019-0405.
PubMed 31760824
Kim JH, Chae HW, Chin SO, Ku CR, Park KH, Lim DJ, Kim KJ, Lim JS, Kim G, Choi YM, Ahn SH, Jeon MJ, Hwangbo Y, Lee JH, Kim BK, Choi YJ, Lee KA, Moon SS, Ahn HY, Choi HS, Hong SM, Shin DY, Seo JA, Kim SH, Oh S, Yu SH, Kim BJ, Shin CH, Kim SW, Kim CH, Lee EJ. Diagnosis and Treatment of Growth Hormone Deficiency: A Position Statement from Korean Endocrine Society and Korean Society of Pediatric Endocrinology. Endocrinol Metab (Seoul). 2020 Jun;35(2):272-287. doi: 10.3803/EnM.2020.35.2.272. Epub 2020 Jun 24.
PubMed 32615711
Ranke MB, Wit JM. Growth hormone - past, present and future. Nat Rev Endocrinol. 2018 May;14(5):285-300. doi: 10.1038/nrendo.2018.22. Epub 2018 Mar 16.
PubMed 29546874
Cunningham BC, Ultsch M, De Vos AM, Mulkerrin MG, Clauser KR, Wells JA. Dimerization of the extracellular domain of the human growth hormone receptor by a single hormone molecule. Science. 1991 Nov 8;254(5033):821-5. doi: 10.1126/science.1948064.
PubMed 1948064
Kopchick JJ, Parkinson C, Stevens EC, Trainer PJ. Growth hormone receptor antagonists: discovery, development, and use in patients with acromegaly. Endocr Rev. 2002 Oct;23(5):623-46. doi: 10.1210/er.2001-0022.
PubMed 12372843
DOI:10.3969/j.issn.2095-1736.2020.05.103.
de Fries Jensen L, Antavalis V, Odgaard-Jensen J, Rossi A, Pietropoli A, Hojby M. Efficacy and Safety of Somapacitan Relative to Somatrogon and Lonapegsomatropin in Pediatric Growth Hormone Deficiency: Systematic Literature Review and Network Meta-analysis. Adv Ther. 2024 Nov;41(11):4098-4124. doi: 10.1007/s12325-024-02966-y. Epub 2024 Sep 11.
PubMed 39261416

Interested in taking part?

Yanqing Lin

86-0755-23018589

linyanqing@kexing.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Study at a glance

From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II/III, Seamless, Multicenter, Randomized, Open-Label, Positive-Comparator Controlled Clinical Trial to Evaluate the Efficacy and Safety of GB08 Injection in Pediatric Patients With Growth Hormone Deficiency
ClinicalTrials.gov ID: NCT07126288
Acronym / sponsor ID: KXZY-GB08-201
Conditions: Growth Hormone Deficiency in Children, Growth Hormone Deficiency (GHD), Growth Hormone
Keywords: growth hormone deficiency, annualized height velocity, growth hormone, clinical trial, GB08 injection
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 268 participants (estimated)
Lead sponsor: Shenzhen Kexing Pharmaceutical Co., Ltd.Research network
Study start: 31 Aug 2025 (estimated)
Primary completion: 15 Sep 2028 (estimated)
Study completion: 23 Dec 2028 (estimated)
First posted: 17 Aug 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

1: Does GB08 injection demonstrate comparable efficacy in treating PGHD at 24 weeks compared to Norditropin NordiFlex?
2: Which dose (0.4 mg/kg, 0.8 mg/kg, and 1.2 mg/kg) of GB08 injection best balances efficacy and safety in treating PGHD at 24 weeks?
3: Does GB08 injection maintain its efficacy in treating PGHD at 52 weeks compared to Norditropin NordiFlex? To achieve these, GB08 injection will be compared to Norditropin NordiFlex to see if it provides a more effective or safer treatment option for PGHD.

Detailed description

Phase II: Identifying the Optimal Dose This part assesses the efficacy and safety of three doses of GB08 in treating PGHD to recommend the optimal dose for the phase III.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Single blind (outcomes assessor)
Number of arms: 6
Model description: Phase II/III seamless design clinical study

Arm	Type	Receives
PhaseII GB08 0.4 mg/kg	Experimental	Drug: GB08GB08 0.4mg/kg subcutaneous injection, once a week for 24 weeks
PhaseII GB08 0.8 mg/kg	Experimental	Drug: GB08GB08 0.8mg/kg subcutaneous injection, once a week for 24 weeks
PhaseII GB08 1.2 mg/kg	Experimental	Drug: GB08GB08 1.2mg/kg subcutaneous injection, once a week for 24 weeks
PhaseII Norditropin NordiFlex	Active comparator	Drug: Norditropin NordiFlexNorditropin NordiFlex 0.035 mg/kg subcutaneous injection, daily, for 24 weeks
PhaseIII GB08	Experimental	Drug: GB08GB08 subcutaneous injection (The dose will be determined by data from PhaseII), once a week for 52 weeks
PhaseIII Norditropin NordiFlex	Active comparator	Drug: Norditropin NordiFlexNorditropin NordiFlex 0.035 mg/kg subcutaneous injection, daily, for 52 weeks

Who may qualify

Ages: 3 to 11 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (9 listed)

1. Diagnosed with Growth Hormone Deficiency (GHD) based on medical history, clinical symptoms and signs, GH stimulation tests, and imaging studies. The participant must meet the following:
Absolute height 2 standard deviations (SD) below the mean height of children of the same age and sex, according to the standardized growth curves for children and adolescents in China (0-18 years old) published in 2009.
Annualized height velocity (AHV) ≤ 5.0 cm/year, calculated from measurement of 6 to 18 months before screening.
GH peak ≤ 10 ng/ml proved by two different GH stimulation tests within a year before screening.
Bone age lagging at least 1 year behind actual age (bone age assessment within the past 6 months before screening), with girls < 10 years old and boys < 11 years old.

Key exclusion criteria (15 listed)

History of systematic growth-promoting therapy, including growth hormone and sex hormones.
Severe allergic constitution or known allergy to growth hormone or its excipients, such as mannitol, lysine, or sodium chloride.
Closed epiphyses.
Other types of growth disorders such as idiopathic short stature, Turner syndrome, Noonan syndrome, Prader-Willi syndrome, and Russell-Silver syndrome.
Short stature due to other causes, such as intrauterine growth restriction, familial short stature, thyroid hormone deficiency, adrenal insufficiency, antidiuretic hormone deficiency, celiac disease, rickets, psychological factors, chronic kidney disease, infections, or trauma.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GB08In Phase II trial, eligible PGHD patients will receive GB08 0.4mg/kg, 0.8mg/kg, or 1.2mg/kg subcutaneous injection, once a week for 24 weeks. In Phase III trial, the individuals will receive GB08 subcutaneous injection, once a week for 52 weeks. The dose of GB08 at this stage will be determined by the outcomes of Phase II.	Drug	PhaseII GB08 0.4 mg/kg, PhaseII GB08 0.8 mg/kg, PhaseII GB08 1.2 mg/kg, PhaseIII GB08
Norditropin NordiFlexNorditropin NordiFlex 0.035 mg/kg subcutaneous injection, daily, for 24 weeks (Phase II) or 52 weeks (Phase III)	Drug	PhaseII Norditropin NordiFlex, PhaseIII Norditropin NordiFlex

Primary outcome

PhaseII-Comparison of annualized height velocity at 24 weeks
Time frame: From enrollment to end of treatment at 24 weeks
Comparison of annualized height velocity of PGHD patients receiving 24-week GB08 and Norditropin NordiFlex treatment
PhaseIII-Comparison of annualized height velocity at week 52
Time frame: From enrollment to end of treatment at week 52
Comparison of annualized height velocity between PGHD patients receiving GB08 and Norditropin NordiFlex at 52 weeks

24 secondary outcomes

PhaseII-annualized height velocity at weeks 4, 12, 36, 48, 52
Time frame: From enrollment to weeks 4, 12, 36, 48, 52
PhaseII-Standard deviation (SD) scores of AHV of GB08 injection and Norditropin NordiFlex at baseline, and at weeks 4, 12, 36, 48, 52
Time frame: From enrollment to weeks 4, 12, 36, 48, 52
PhaseII-Standard deviation of actual height SDS (Ht SDS CA) of GB08 injection and Norditropin NordiFlex at weeks 4, 12, 24, 36, 48, 52
Time frame: From enrollment to weeks 4, 12, 24, 36, 48, 52
PhaseII-Standard deviation of bone age (BA) SDS (Ht SDS BA) of GB08 injection and Norditropin NordiFlex at week 24 and 52
Time frame: From enrollment to weeks 24 and 52
PhaseII-Tanner stage changes at baseline and at weeks 12, 24, 52
Time frame: From enrollment to weeks 12, 24, and 52
PhaseII-Body weight and BMI changes at baseline and at weeks 2, 4, 8, 12, 24, 52
Time frame: From enrollment to weeks 2, 4, 8, 12, 24, and 52
PhaseII-Ratio of BA to CA at baseline and at weeks 24, 52
Time frame: From enrollment to weeks 24 and 52
PhaseII-Serum IGF-1, IGF-1 SDS, and IGFBP-3 levels, and their changes from baseline at weeks 2, 4, 8, 12, 24, 36, 48, 52
Time frame: From enrollment to weeks 2, 4, 8, 12, 24, 36, 48, and 52
PhaseII-Serum IGF-1, IGF-1 SDS, and IGFBP-3 levels, and their changes from baseline at 48 hours post-dose of GB08 injection at weeks 2, 4, 8, 12, 24, 36, 48, 52
Time frame: From enrollment to weeks 2, 4, 8, 12, 24, 36, 48, and 52
PhaseIII-AHV of GB08 injection and Norditropin NordiFlex at baseline, and at weeks 4, 12, 24, 36, 48, 52
Time frame: From enrollment to weeks 4, 12, 24, 36, 48, and 52
PhaseIII-Standard deviation (SD) scores of AHV of GB08 injection and Norditropin NordiFlex at baseline, and at weeks 4, 12, 24, 36, 48, 52
Time frame: From enrollment to weeks 4, 12, 24, 36, 48, and 52
PhaseIII-Standard deviation of actual height SDS (Ht SDS CA) of GB08 injection and Norditropin NordiFlex at weeks 4, 12, 24, 36, 48, 52
Time frame: From enrollment to weeks 4, 12, 24, 36, 48, and 52
PhaseIII-Standard deviation of bone age (BA) SDS (Ht SDS BA) of GB08 injection and Norditropin NordiFlex at week 52
Time frame: From enrollment to week 52
PhaseIII-Tanner stage changes at baseline and at weeks 12, 24, 52
Time frame: From enrollment to weeks 12, 24, and 52
PhaseIII-Body weight and BMI changes at baseline and at weeks 2, 4, 8, 12, 24, 52
Time frame: From enrollment to weeks 2, 4, 8, 12, 24, and 52
PhaseIII-Serum IGF-1, IGF-1 SDS, and IGFBP-3 levels, and their changes from baseline at weeks 2, 4, 8, 12, 24, 36, 48, 52
Time frame: From enrollment to weeks 2, 4, 8, 12, 24, 36, 48, and 52
PhaseIII-Serum IGF-1, IGF-1 SDS, and IGFBP-3 levels, and their changes from baseline at 48 hours post-dose of GB08 injection at weeks 2, 4, 8, 12, 24, 36, 48, 52
Time frame: From enrollment to weeks 2, 4, 8, 12, 24, 36, 48, and 52
PhaseII-Safety Evaluation Endpoints
Time frame: weeks 2, 4, 8, 12, 24, 36, 48, 52.
PhaseII-Immunogenicity Evaluation Endpoints
Time frame: weeks 12, 24, 36, 52
PhaseII-Pharmacokinetics Evaluation Endpoints
Time frame: weeks 2, 4, 8, 12, 24, 36, 48, 52.
PhaseII-Pharmacodynamics Evaluation Endpoints
Time frame: time 0 to 168 hours
PhaseIII-Safety Evaluation Endpoints
Time frame: weeks 2, 4, 8, 12, 24, 36, 48, 52
PhaseIII-Immunogenicity Evaluation Endpoints
Time frame: weeks 12, 24, 36, 52
PhaseIII-Pharmacodynamics Evaluation Endpoints
Time frame: weeks 12, 24, 36, 52

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
Background: PubMed 27009113Christiansen JS, Backeljauw PF, Bidlingmaier M, Biller BM, Boguszewski MC, Casanueva FF, Chanson P, Chatelain P, Choong CS, Clemmons DR, Cohen LE, Cohen P, Frystyk J, Grimberg A, Hasegawa Y, Haymond MW, Ho K, Hoffman AR, Holly JM, Horikawa R, Hoybye C, Jorgensen JO, Johannsson G, Juul A, Katznelson L, Kopchick JJ, Lee KO, Lee KW, Luo X, Melmed S, Miller BS, Misra M, Popovic V, Rosenfeld RG, Ross J, Ross RJ, Saenger P, Strasburger CJ, Thorner MO, Werner H, Yuen K. Growth Hormone Research Society perspective on the development of long-acting growth hormone preparations. Eur J Endocrinol. 2016 Jun;174(6):C1-8. doi: 10.1530/EJE-16-0111. Epub 2016 Mar 23.
Background: PubMed 18308651Rosenfeld RG, Bakker B. Compliance and persistence in pediatric and adult patients receiving growth hormone therapy. Endocr Pract. 2008 Mar;14(2):143-54. doi: 10.4158/EP.14.2.143.
Background: PubMed 26563978Allen DB, Backeljauw P, Bidlingmaier M, Biller BM, Boguszewski M, Burman P, Butler G, Chihara K, Christiansen J, Cianfarani S, Clayton P, Clemmons D, Cohen P, Darendeliler F, Deal C, Dunger D, Erfurth EM, Fuqua JS, Grimberg A, Haymond M, Higham C, Ho K, Hoffman AR, Hokken-Koelega A, Johannsson G, Juul A, Kopchick J, Lee P, Pollak M, Radovick S, Robison L, Rosenfeld R, Ross RJ, Savendahl L, Saenger P, Sorensen HT, Stochholm K, Strasburger C, Swerdlow A, Thorner M. GH safety workshop position paper: a critical appraisal of recombinant human GH therapy in children and adults. Eur J Endocrinol. 2016 Feb;174(2):P1-9. doi: 10.1530/EJE-15-0873. Epub 2015 Nov 12.
Background: PubMed 22271255Cook DM, Rose SR. A review of guidelines for use of growth hormone in pediatric and transition patients. Pituitary. 2012 Sep;15(3):301-10. doi: 10.1007/s11102-011-0372-6.
Background: PubMed 31760824Yuen KCJ, Biller BMK, Radovick S, Carmichael JD, Jasim S, Pantalone KM, Hoffman AR. AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY GUIDELINES FOR MANAGEMENT OF GROWTH HORMONE DEFICIENCY IN ADULTS AND PATIENTS TRANSITIONING FROM PEDIATRIC TO ADULT CARE. Endocr Pract. 2019 Nov;25(11):1191-1232. doi: 10.4158/GL-2019-0405.
Background: PubMed 32615711Kim JH, Chae HW, Chin SO, Ku CR, Park KH, Lim DJ, Kim KJ, Lim JS, Kim G, Choi YM, Ahn SH, Jeon MJ, Hwangbo Y, Lee JH, Kim BK, Choi YJ, Lee KA, Moon SS, Ahn HY, Choi HS, Hong SM, Shin DY, Seo JA, Kim SH, Oh S, Yu SH, Kim BJ, Shin CH, Kim SW, Kim CH, Lee EJ. Diagnosis and Treatment of Growth Hormone Deficiency: A Position Statement from Korean Endocrine Society and Korean Society of Pediatric Endocrinology. Endocrinol Metab (Seoul). 2020 Jun;35(2):272-287. doi: 10.3803/EnM.2020.35.2.272. Epub 2020 Jun 24.
Background: PubMed 29546874Ranke MB, Wit JM. Growth hormone - past, present and future. Nat Rev Endocrinol. 2018 May;14(5):285-300. doi: 10.1038/nrendo.2018.22. Epub 2018 Mar 16.
Background: PubMed 1948064Cunningham BC, Ultsch M, De Vos AM, Mulkerrin MG, Clauser KR, Wells JA. Dimerization of the extracellular domain of the human growth hormone receptor by a single hormone molecule. Science. 1991 Nov 8;254(5033):821-5. doi: 10.1126/science.1948064.
Background: PubMed 12372843Kopchick JJ, Parkinson C, Stevens EC, Trainer PJ. Growth hormone receptor antagonists: discovery, development, and use in patients with acromegaly. Endocr Rev. 2002 Oct;23(5):623-46. doi: 10.1210/er.2001-0022.
BackgroundDOI:10.3969/j.issn.2095-1736.2020.05.103.
Background: PubMed 39261416de Fries Jensen L, Antavalis V, Odgaard-Jensen J, Rossi A, Pietropoli A, Hojby M. Efficacy and Safety of Somapacitan Relative to Somatrogon and Lonapegsomatropin in Pediatric Growth Hormone Deficiency: Systematic Literature Review and Network Meta-analysis. Adv Ther. 2024 Nov;41(11):4098-4124. doi: 10.1007/s12325-024-02966-y. Epub 2024 Sep 11.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Yanqing Lin contact

86-0755-23018589

linyanqing@kexing.com

Jinhai Lin contact

86-13760806104

linjinhai@kexing.com

Junfen Fu principal investigator

The Children's Hospital of Zhejiang University School of Medicine

Yijia Zhang study director

Shenzhen Kexing Pharmaceutical Co., Ltd.

16 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yanqing Lin (86-0755-23018589, linyanqing@kexing.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PhaseII-Comparison of annualized height velocity at 24 weeks (time frame: From enrollment to end of treatment at 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07126288, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.