BACKGROUND: A sustained-release recombinant human GH formulation, LB03002, has been recently developed, with pharmacokinetics and pharmacodynamic activity appropriate for once-weekly administration. LB03002 is a long-acting GH that is administered once a week by s.c. injection. OBJECTIVE: This study evaluated efficacy and safety of LB03002 in adult patients with GH deficiency. PATIENTS AND METHODS: A total of 152 patients were randomized to receive LB03002 or placebo once weekly for 26 wk. Changes in body composition were evaluated from DXA (dual-energy x-ray absorptiometry). IGF-I was assessed at each study visit. Safety was assessed from adverse events, glucose homeostasis, and antibody development. RESULTS:IGF-I increased significantly (P < 0.001) with LB03002 and remained unchanged with placebo. Mean fat mass (FM) decreased by 1.052 kg [95% confidence interval (CI) = -1.614 to -0.491] in the LB03002 group vs. an increase of 0.570 kg (95% CI = -0.205-1.345) in the placebo group; treatment difference was 1.622 kg (95% CI = -2.527 to -0.717; P < 0.001). FM change was mainly due to decreased trunk fat. Least square mean treatment difference was 1.032 kg (95% CI = -1.560 to -0.515; P < 0.001). LBM (lean body mass) was significantly increased with LB03002 vs. placebo (least square mean difference was 1.393 kg; 95% CI = 0.614-2.171; P < 0.001). No concerning safety issues arose during the study. CONCLUSIONS: Weekly GH replacement with the sustained-release preparation LB03002 in adults significantly reduced FM over 6 months and was well tolerated.
RCT Entities:
BACKGROUND: A sustained-release recombinant human GH formulation, LB03002, has been recently developed, with pharmacokinetics and pharmacodynamic activity appropriate for once-weekly administration. LB03002 is a long-acting GH that is administered once a week by s.c. injection. OBJECTIVE: This study evaluated efficacy and safety of LB03002 in adult patients with GH deficiency. PATIENTS AND METHODS: A total of 152 patients were randomized to receive LB03002 or placebo once weekly for 26 wk. Changes in body composition were evaluated from DXA (dual-energy x-ray absorptiometry). IGF-I was assessed at each study visit. Safety was assessed from adverse events, glucose homeostasis, and antibody development. RESULTS:IGF-I increased significantly (P < 0.001) with LB03002 and remained unchanged with placebo. Mean fat mass (FM) decreased by 1.052 kg [95% confidence interval (CI) = -1.614 to -0.491] in the LB03002 group vs. an increase of 0.570 kg (95% CI = -0.205-1.345) in the placebo group; treatment difference was 1.622 kg (95% CI = -2.527 to -0.717; P < 0.001). FM change was mainly due to decreased trunk fat. Least square mean treatment difference was 1.032 kg (95% CI = -1.560 to -0.515; P < 0.001). LBM (lean body mass) was significantly increased with LB03002 vs. placebo (least square mean difference was 1.393 kg; 95% CI = 0.614-2.171; P < 0.001). No concerning safety issues arose during the study. CONCLUSIONS: Weekly GH replacement with the sustained-release preparation LB03002 in adults significantly reduced FM over 6 months and was well tolerated.
Authors: Beverly M K Biller; Hyi-Jeong Ji; Hyunji Ahn; Conrad Savoy; E Christine Siepl; Vera Popovic; Mihail Coculescu; Josefine Roemmler; Catalin Gavrila; David M Cook; Christian J Strasburger Journal: Pituitary Date: 2013-09 Impact factor: 4.107
Authors: Jeffrey L Cleland; Nathan C Geething; Jerome A Moore; Brian C Rogers; Benjamin J Spink; Chai-Wei Wang; Susan E Alters; Willem P C Stemmer; Volker Schellenberger Journal: J Pharm Sci Date: 2012-06-07 Impact factor: 3.534
Authors: Kevin C J Yuen; Gerard S Conway; Vera Popovic; George R Merriam; Timothy Bailey; Amir H Hamrahian; Beverly M K Biller; Mark Kipnes; Jerome A Moore; Eric Humphriss; George M Bright; Jeffrey L Cleland Journal: J Clin Endocrinol Metab Date: 2013-04-12 Impact factor: 5.958