Once-Weekly Administration of Sustained-Release Growth Hormone in Korean Prepubertal Children with Idiopathic Short Stature: A Randomized, Controlled Phase II Study

Jin Soon Hwang; Hae Sang Lee; Kee Hyoung Lee; Han Wook Yoo; Dae Yeol Lee; Byung Kyu Suh; Cheol Woo Ko; Woo Yeong Chung; Dong Kyu Jin; Choong Ho Shin; Heon Seok Han; Song Han; Ho Seong Kim

doi:10.1159/000489262

Once-Weekly Administration of Sustained-Release Growth Hormone in Korean Prepubertal Children with Idiopathic Short Stature: A Randomized, Controlled Phase II Study

Jin Soon Hwang, Hae Sang Lee, Kee Hyoung Lee, Han Wook Yoo, Dae Yeol Lee, Byung Kyu Suh, Cheol Woo Ko, Woo Yeong Chung, Dong Kyu Jin, Choong Ho Shin, Heon Seok Han, Song Han, Ho Seong Kim

Research output: Contribution to journal › Article › peer-review

17 Citations (Scopus)

Abstract

Background/Aims: To determine the optimal dose of LB03002, a sustained-release, once-weekly formulation of recombinant human growth hormone (rhGH), and to compare its efficacy and safety with daily rhGH in children with idiopathic short stature (ISS). Methods: This multicenter, randomized, open-label, phase II study included GH-naïve, prepubertal children with ISS, randomized to receive daily rhGH 0.37 mg/kg/week (control, n = 16), LB03002 0.5 mg/kg/week (n = 14), or LB03002 0.7 mg/kg/week (n = 16). The primary endpoint was height velocity (HV) change at week 26. Results: At week 26, the least square (LS) means for HV change (cm/year) with control, LB03002 0.5 mg/kg/week, and LB03002 0.7 mg/kg/week were 5.08, 3.65, and 4.38, and the LS means for the change in height standard deviation score were 0.65, 0.49, and 0.58, respectively. The lower bound of the 90% confidence interval for the difference between LB03002 0.7 mg/kg/week and the control in the LS mean for HV change (-1.72) satisfied the noninferiority margin (-1.75). Adverse events were generally mild and short-lived. Conclusion: A once-weekly regimen of LB03002 0.7 mg/kg demonstrated noninferiority to the daily regimen of rhGH 0.37 mg/kg/week in terms of HV increments. LB03002 was well tolerated and its safety profile was comparable with that of daily rhGH.

Original language	English
Pages (from-to)	54-63
Number of pages	10
Journal	Hormone Research in Paediatrics
Volume	90
Issue number	1
DOIs	https://doi.org/10.1159/000489262
Publication status	Published - 2018 Sept 1

Bibliographical note

Funding Information:
This study was sponsored by LG Life Sciences, Ltd., which is now merged with LG Chem, Ltd., Korea. S.H. is employed by LG Chem, Ltd. J.S.H., K.-H.L., H.-W.Y., B.-K.S., C.H.S., H.-S.H., H.-S.K., and C.H.S. are the Steering Committee members of LGS (LG Growth Study). Otherwise, the authors have no competing interest to declare that could be perceived as prejudicing the impartiality of the research reported.

Funding Information:
We thank the patients and their caregivers; Suin Lee of LG Chem, Ltd., for her support in clinical operations; and Hye-Ryon Kim and Szymon Bruzewicz (SciencePro) for editorial assistance in the preparation of the manuscript.

Publisher Copyright:
© 2018 The Author(s). Published by S. Karger AG, Basel.

Keywords

Height velocity
Idiopathic short stature
Sustained-release growth hormone

ASJC Scopus subject areas

Pediatrics, Perinatology, and Child Health
Endocrinology, Diabetes and Metabolism
Endocrinology

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1159/000489262

Cite this

Hwang, J. S., Lee, H. S., Lee, K. H., Yoo, H. W., Lee, D. Y., Suh, B. K., Ko, C. W., Chung, W. Y., Jin, D. K., Shin, C. H., Han, H. S., Han, S., & Kim, H. S. (2018). Once-Weekly Administration of Sustained-Release Growth Hormone in Korean Prepubertal Children with Idiopathic Short Stature: A Randomized, Controlled Phase II Study. Hormone Research in Paediatrics, 90(1), 54-63. https://doi.org/10.1159/000489262

Hwang, JS, Lee, HS, Lee, KH, Yoo, HW, Lee, DY, Suh, BK, Ko, CW, Chung, WY, Jin, DK, Shin, CH, Han, HS, Han, S & Kim, HS 2018, 'Once-Weekly Administration of Sustained-Release Growth Hormone in Korean Prepubertal Children with Idiopathic Short Stature: A Randomized, Controlled Phase II Study', Hormone Research in Paediatrics, vol. 90, no. 1, pp. 54-63. https://doi.org/10.1159/000489262

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title = "Once-Weekly Administration of Sustained-Release Growth Hormone in Korean Prepubertal Children with Idiopathic Short Stature: A Randomized, Controlled Phase II Study",

abstract = "Background/Aims: To determine the optimal dose of LB03002, a sustained-release, once-weekly formulation of recombinant human growth hormone (rhGH), and to compare its efficacy and safety with daily rhGH in children with idiopathic short stature (ISS). Methods: This multicenter, randomized, open-label, phase II study included GH-na{\"i}ve, prepubertal children with ISS, randomized to receive daily rhGH 0.37 mg/kg/week (control, n = 16), LB03002 0.5 mg/kg/week (n = 14), or LB03002 0.7 mg/kg/week (n = 16). The primary endpoint was height velocity (HV) change at week 26. Results: At week 26, the least square (LS) means for HV change (cm/year) with control, LB03002 0.5 mg/kg/week, and LB03002 0.7 mg/kg/week were 5.08, 3.65, and 4.38, and the LS means for the change in height standard deviation score were 0.65, 0.49, and 0.58, respectively. The lower bound of the 90% confidence interval for the difference between LB03002 0.7 mg/kg/week and the control in the LS mean for HV change (-1.72) satisfied the noninferiority margin (-1.75). Adverse events were generally mild and short-lived. Conclusion: A once-weekly regimen of LB03002 0.7 mg/kg demonstrated noninferiority to the daily regimen of rhGH 0.37 mg/kg/week in terms of HV increments. LB03002 was well tolerated and its safety profile was comparable with that of daily rhGH.",

keywords = "Height velocity, Idiopathic short stature, Sustained-release growth hormone",

author = "Hwang, {Jin Soon} and Lee, {Hae Sang} and Lee, {Kee Hyoung} and Yoo, {Han Wook} and Lee, {Dae Yeol} and Suh, {Byung Kyu} and Ko, {Cheol Woo} and Chung, {Woo Yeong} and Jin, {Dong Kyu} and Shin, {Choong Ho} and Han, {Heon Seok} and Song Han and Kim, {Ho Seong}",

note = "Funding Information: This study was sponsored by LG Life Sciences, Ltd., which is now merged with LG Chem, Ltd., Korea. S.H. is employed by LG Chem, Ltd. J.S.H., K.-H.L., H.-W.Y., B.-K.S., C.H.S., H.-S.H., H.-S.K., and C.H.S. are the Steering Committee members of LGS (LG Growth Study). Otherwise, the authors have no competing interest to declare that could be perceived as prejudicing the impartiality of the research reported. Funding Information: We thank the patients and their caregivers; Suin Lee of LG Chem, Ltd., for her support in clinical operations; and Hye-Ryon Kim and Szymon Bruzewicz (SciencePro) for editorial assistance in the preparation of the manuscript. Publisher Copyright: {\textcopyright} 2018 The Author(s). Published by S. Karger AG, Basel.",

year = "2018",

month = sep,

day = "1",

doi = "10.1159/000489262",

language = "English",

volume = "90",

pages = "54--63",

journal = "Hormone Research in Paediatrics",

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publisher = "S. Karger AG",

number = "1",

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TY - JOUR

T1 - Once-Weekly Administration of Sustained-Release Growth Hormone in Korean Prepubertal Children with Idiopathic Short Stature

T2 - A Randomized, Controlled Phase II Study

AU - Hwang, Jin Soon

AU - Lee, Hae Sang

AU - Lee, Kee Hyoung

AU - Yoo, Han Wook

AU - Lee, Dae Yeol

AU - Suh, Byung Kyu

AU - Ko, Cheol Woo

AU - Chung, Woo Yeong

AU - Jin, Dong Kyu

AU - Shin, Choong Ho

AU - Han, Heon Seok

AU - Han, Song

AU - Kim, Ho Seong

N1 - Funding Information: This study was sponsored by LG Life Sciences, Ltd., which is now merged with LG Chem, Ltd., Korea. S.H. is employed by LG Chem, Ltd. J.S.H., K.-H.L., H.-W.Y., B.-K.S., C.H.S., H.-S.H., H.-S.K., and C.H.S. are the Steering Committee members of LGS (LG Growth Study). Otherwise, the authors have no competing interest to declare that could be perceived as prejudicing the impartiality of the research reported. Funding Information: We thank the patients and their caregivers; Suin Lee of LG Chem, Ltd., for her support in clinical operations; and Hye-Ryon Kim and Szymon Bruzewicz (SciencePro) for editorial assistance in the preparation of the manuscript. Publisher Copyright: © 2018 The Author(s). Published by S. Karger AG, Basel.

PY - 2018/9/1

Y1 - 2018/9/1

N2 - Background/Aims: To determine the optimal dose of LB03002, a sustained-release, once-weekly formulation of recombinant human growth hormone (rhGH), and to compare its efficacy and safety with daily rhGH in children with idiopathic short stature (ISS). Methods: This multicenter, randomized, open-label, phase II study included GH-naïve, prepubertal children with ISS, randomized to receive daily rhGH 0.37 mg/kg/week (control, n = 16), LB03002 0.5 mg/kg/week (n = 14), or LB03002 0.7 mg/kg/week (n = 16). The primary endpoint was height velocity (HV) change at week 26. Results: At week 26, the least square (LS) means for HV change (cm/year) with control, LB03002 0.5 mg/kg/week, and LB03002 0.7 mg/kg/week were 5.08, 3.65, and 4.38, and the LS means for the change in height standard deviation score were 0.65, 0.49, and 0.58, respectively. The lower bound of the 90% confidence interval for the difference between LB03002 0.7 mg/kg/week and the control in the LS mean for HV change (-1.72) satisfied the noninferiority margin (-1.75). Adverse events were generally mild and short-lived. Conclusion: A once-weekly regimen of LB03002 0.7 mg/kg demonstrated noninferiority to the daily regimen of rhGH 0.37 mg/kg/week in terms of HV increments. LB03002 was well tolerated and its safety profile was comparable with that of daily rhGH.

AB - Background/Aims: To determine the optimal dose of LB03002, a sustained-release, once-weekly formulation of recombinant human growth hormone (rhGH), and to compare its efficacy and safety with daily rhGH in children with idiopathic short stature (ISS). Methods: This multicenter, randomized, open-label, phase II study included GH-naïve, prepubertal children with ISS, randomized to receive daily rhGH 0.37 mg/kg/week (control, n = 16), LB03002 0.5 mg/kg/week (n = 14), or LB03002 0.7 mg/kg/week (n = 16). The primary endpoint was height velocity (HV) change at week 26. Results: At week 26, the least square (LS) means for HV change (cm/year) with control, LB03002 0.5 mg/kg/week, and LB03002 0.7 mg/kg/week were 5.08, 3.65, and 4.38, and the LS means for the change in height standard deviation score were 0.65, 0.49, and 0.58, respectively. The lower bound of the 90% confidence interval for the difference between LB03002 0.7 mg/kg/week and the control in the LS mean for HV change (-1.72) satisfied the noninferiority margin (-1.75). Adverse events were generally mild and short-lived. Conclusion: A once-weekly regimen of LB03002 0.7 mg/kg demonstrated noninferiority to the daily regimen of rhGH 0.37 mg/kg/week in terms of HV increments. LB03002 was well tolerated and its safety profile was comparable with that of daily rhGH.

KW - Height velocity

KW - Idiopathic short stature

KW - Sustained-release growth hormone

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U2 - 10.1159/000489262

DO - 10.1159/000489262

M3 - Article

C2 - 29925064

AN - SCOPUS:85048875519

SN - 1663-2818

VL - 90

SP - 54

EP - 63

JO - Hormone Research in Paediatrics

JF - Hormone Research in Paediatrics

IS - 1

ER -

Once-Weekly Administration of Sustained-Release Growth Hormone in Korean Prepubertal Children with Idiopathic Short Stature: A Randomized, Controlled Phase II Study

Abstract

Bibliographical note

Keywords

ASJC Scopus subject areas

UN SDGs

Access to Document

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