Efficacy and safety of LB03002, a once-weekly sustained-release human GH for 12-month treatment in Korean children with GH deficiency

Abstract

Purpose: The purpose of this study was to investigate the efficacy and safety of LB03002, a sustainedrelease human GH (SR-hGH), compared with that of daily rhGH for 12 months in children with GH deficiency (GHD). Methods: A total of 73 children with GHD were screened and 63 eligible subjects were randomized in a 1:1 ratio of LB03002 (SR-hGH) to daily rhGH treatment group. LB03002 was administered once weekly at a dose of 0.5 mg/kg while daily rhGH was administered for 6 consecutive days with equally divided doses to make a total of 0.21 mg/kg per week. Treatments were given for 12 months by s.c. injections. Injection site reactions and adverse events were investigated throughout the study period. Results: The mean (S.D.) height velocity (HV) showed a clinically significant increase after the 6-month treatment: 3.00 (1.15) cm/year at screening to 9.78 (1.98) cm/year at 6 months in the LB03002 group; 2.39 (1.63) cm/year at screening to 10.56 (2.65) cm/year at 6 months in the daily rhGH group. The increased HV at 12 months was still maintained in both the groups: 9.06 (1.63) cm/year at 12 months in the LB03002 group; 9.72 (2.32) cm/year at 12 months in the daily rhGH group. Most of the adverse drug reactions were mild and tolerable. No subjects were withdrawn due to adverse events. Conclusion: Weekly injection of LB03002 at a dose of 0.5 mg/kg per week was confirmed to have comparable efficacy to daily injection of rhGH at a dose of 0.21 mg/kg per week. Both formulations were well tolerated.

RETRACTED: Effect of Weekly Long-Acting Growth Hormone Replacement Therapy Compared to Daily Growth Hormone on Children With Short Stature: A Meta-Analysis

“…A total of 1,245 unique studies were identified, of which 11 studies (between 2012 and 2021) fulfilled the inclusion criteria and were included in the study (25)(26)(27)(28)(29)(30)(31)(32)(33)(34)(35).…”

Long-acting PEGylated recombinant human growth hormone (Jintrolong) for children with growth hormone deficiency: phase II and phase III multicenter, randomized studies

“…The safety profile of our PEG-rhGH was mostly consistent with previous reports of long-acting rhGH (9, 10, 11, 12). Our study did show higher incidence of peripheral edema associated with PEG-rhGH vs daily rhGH, while previous studies on LB03002 and Neutropin Depot did not report increased incidence of peripheral edema in pediatric patients with GHD (2, 11, 12, 21). In our study, most incidences of edema experienced by patients were mild and resolved themselves without treatment interruption.…”

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

“…The first plausible explanation is that the LB03002 dose (0.5 mg/kg/week) might not have been high enough to improve the HV of children with ISS. In the previous phase III trial of Korean GHD patients [15], HV achieved after administration of LB03002 at 0.5 mg/kg/week was not inferior to that obtained with daily rhGH 0.21 mg/kg/week. This implies that a higher dose (0.7 mg/kg/week) of LB03002 should be considered for children with ISS.…”