CClinicalTrials.gg
Sign In
Not yet recruitingNCT07126288Updated Aug 22, 2025

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

A Phase 2/3 interventional study of GB08 and Norditropin NordiFlex in Growth Hormone Deficiency in Children, Growth Hormone Deficiency (GHD) and Growth Hormone, sponsored by Shenzhen Kexing Pharmaceutical Co., Ltd.. Not yet recruiting at 16 sites in China. Open to participants aged 3 Years to 11 Years. Per ClinicalTrials.gov, last updated 2025-08-22.

Sponsored by Shenzhen Kexing Pharmaceutical Co., Ltd. · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
268
Allocation
Randomized
Ages
3 Years to 11 Years
Sex
All
01

Study 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 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.

02

Conditions studied

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

Browse trials for

Keywords

  • growth hormone deficiency
  • annualized height velocity
  • growth hormone
  • clinical trial
  • GB08 injection
03

In context

Dwarfism, Pituitary

164 studies on the registry are indexed under Dwarfism, Pituitary; 25 are open to participants now.

This study's planned enrollment of 268 is above the median of 72 across 122 interventional studies indexed under Dwarfism, Pituitary.

Browse Dwarfism, Pituitary studies →

Lead sponsor

Shenzhen Kexing Pharmaceutical Co., Ltd. is the lead sponsor of 6 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 11 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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:

  1. 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.
  2. Annualized height velocity (AHV) ≤ 5.0 cm/year, calculated from measurement of 6 to 18 months before screening.
  3. GH peak ≤ 10 ng/ml proved by two different GH stimulation tests within a year before screening.
  4. 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).

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.

Exclusion criteria

Exclusion Criteria:

  1. History of systematic growth-promoting therapy, including growth hormone and sex hormones.
  2. Severe allergic constitution or known allergy to growth hormone or its excipients, such as mannitol, lysine, or sodium chloride.
  3. Closed epiphyses.
  4. Other types of growth disorders such as idiopathic short stature, Turner syndrome, Noonan syndrome, Prader-Willi syndrome, and Russell-Silver syndrome.
  5. 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.
  6. 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.
  7. 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).
  8. Use of corticosteroids or other steroids within the past 12 months, such as long-term steroid use for asthma.
  9. History of pituitary or hypothalamic tumors, or other intracranial tumors on MRI; history of leukemia, lymphoma, or other malignancies.
  10. History of radiation therapy or chemotherapy.
  11. Congenital intracranial hypertension.
  12. Femoral head slipped epiphysis (SCFE).
  13. Spinal scoliosis > 15°.
  14. Participation in any other drug clinical trial within the past 3 months (as a subject).
  15. Other factors deemed unsuitable for participation in the study by the investigator.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Single (Outcomes assessor)
Enrollment
268 participants (estimated)

Study arms

  • Experimental
    PhaseII GB08 0.4 mg/kg

    GB08 0.4mg/kg subcutaneous injection, once a week for 24 weeks

    Drug: GB08

  • Experimental
    PhaseII GB08 0.8 mg/kg

    GB08 0.8mg/kg subcutaneous injection, once a week for 24 weeks

    Drug: GB08

  • Experimental
    PhaseII GB08 1.2 mg/kg

    GB08 1.2mg/kg subcutaneous injection, once a week for 24 weeks

    Drug: GB08

  • Active comparator
    PhaseII Norditropin NordiFlex

    Norditropin NordiFlex 0.035 mg/kg subcutaneous injection, daily, for 24 weeks

    Drug: Norditropin NordiFlex

  • Experimental
    PhaseIII GB08

    GB08 subcutaneous injection (The dose will be determined by data from PhaseII), once a week for 52 weeks

    Drug: GB08

  • Active comparator
    PhaseIII Norditropin NordiFlex

    Norditropin NordiFlex 0.035 mg/kg subcutaneous injection, daily, for 52 weeks

    Drug: Norditropin NordiFlex

Interventions

  • DrugGB08

    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.

  • DrugNorditropin NordiFlex

    Norditropin NordiFlex 0.035 mg/kg subcutaneous injection, daily, for 24 weeks (Phase II) or 52 weeks (Phase III)

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: From enrollment to end of treatment at 24 weeks

  2. 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

    Time frame: From enrollment to end of treatment at week 52

Secondary outcomes

  1. PhaseII-annualized height velocity at weeks 4, 12, 36, 48, 52

    Time frame: From enrollment to weeks 4, 12, 36, 48, 52

  2. 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

  3. 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

  4. 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

  5. PhaseII-Tanner stage changes at baseline and at weeks 12, 24, 52

    Time frame: From enrollment to weeks 12, 24, and 52

  6. 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

  7. PhaseII-Ratio of BA to CA at baseline and at weeks 24, 52

    Time frame: From enrollment to weeks 24 and 52

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. PhaseIII-Tanner stage changes at baseline and at weeks 12, 24, 52

    Time frame: From enrollment to weeks 12, 24, and 52

  15. 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

  16. 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

  17. 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

  18. 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.

    Time frame: weeks 2, 4, 8, 12, 24, 36, 48, 52.

  19. 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.

    Time frame: weeks 12, 24, 36, 52

  20. 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).

    Time frame: weeks 2, 4, 8, 12, 24, 36, 48, 52.

  21. 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).

    Time frame: time 0 to 168 hours

  22. 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.

    Time frame: weeks 2, 4, 8, 12, 24, 36, 48, 52

  23. 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.

    Time frame: weeks 12, 24, 36, 52

  24. 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.

    Time frame: weeks 12, 24, 36, 52

07

Study locations

16 sites
  • Xiamen Maternal and Child Health Hospital
    Xiamen, Fujian 361000, China
    • Xiaoqing Yang · Sub investigator
  • Nanyang Central Hospital
    Nanyang, Henan 473000, China
    • Na Xu · Sub investigator
  • The First Affiliated Hospital of Nanyang Medical College
    Nanyang, Henan 473000, China
    • Xiaoxia Shi · Sub investigator
  • The Third Affiliated Hospital of Xinxiang Medical University
    Xinxiang, Henan 453003, China
    • Jinfen Han · Sub investigator
  • Wuhan Children's Hospital
    Wuhan, Hubei 430016, China
    • Hui Yao · Sub investigator
  • Suzhou University Children's Hospital
    Suzhou, Jiangsu 215000, China
    • Rongrong Xie · Sub investigator
  • Jiangxi Children's Hospital
    Nanchang, Jiangxi 330006, China
    • Yu Yang · Sub investigator
  • Pingxiang Maternal and Child Health Hospital
    Pingxiang, Jiangxi 337000, China
    • Li Zhou · Sub investigator
  • The First Hospital of Jilin University
    Changchun, Jilin 130021, China
    • Yining Zhang · Sub investigator
  • Linyi Maternal and Child Health Hospital
    Linyi, Shandong 276000, China
    • Xiuying Ge · Sub investigator
  • Chengdu Women's and Children's Central Hospital
    Chengdu, Sichuan 610017, China
    • Fang Tang · Sub investigator
  • Meishan People's Hospital
    Meishan, Sichuan 620010, China
    • Yangfan Fei · Sub investigator
  • The Second People's Hospital of Yibin
    Yibin, Sichuan 644000, China
    • Lan Yao · Sub investigator
  • Zhejiang Provincial People's Hospital
    Hangzhou, Zhejiang 310014, China
    • Qin Zhou · Sub investigator
  • Children's Hospital of Zhejiang University School of Medicine
    Hangzhou, Zhejiang 310051, China
    • Junfen Fu · Principal investigator
  • Ningbo Women's and Children's Hospital
    Ningbo, Zhejiang 315010, China
    • Shuxia Ding · Sub investigator
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07126288
Lead sponsor
Shenzhen Kexing Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Aug 17, 2025
Start date
Aug 31, 2025 (estimated)
Primary completion
Sep 15, 2028 (estimated)
Completion
Dec 23, 2028 (estimated)
Last update
Aug 22, 2025

Study contacts

Yanqing Lin
Contact
linyanqing@kexing.com
86-0755-23018589
Jinhai Lin
Contact
linjinhai@kexing.com
86-13760806104
Junfen Fu
principal investigator · The Children's Hospital of Zhejiang University School of Medicine
Yijia Zhang
study director · Shenzhen Kexing Pharmaceutical Co., Ltd.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Dwarfism, Pituitary→

Other studies from this sponsor

Shenzhen Kexing Pharmaceutical Co., Ltd.

Start the discussion