Thursday, March 17, 2011

Effects of Once-Weekly Sustained-Release Growth Hormone: A Double-Blind, Placebo-Controlled Study in Adult Growth Hormone Deficiency

 The Journal of Clinical Endocrinology & Metabolism, doi:10.1210/jc.2010-2819

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 and Christian J. Strasburger

Massachusetts General Hospital (B.M.K.B.), Boston, Massachusetts 02114; LG Life Sciences, Ltd. (H.-J.J., H.A.), Seoul 150-721, Korea; Biopartners, GmbH (C.S., E.C.S.), CH-6340 Baar, Switzerland; Institute of Endocrinology (V.P.), HU-11000 Belgrade, Serbia; Institute of Endocrinology (M.C.), C.I. Parhon, 011863 Bucharest, Romania; University of Munich (J.R.), 80336 Munchen, Germany; SANA Medical Center (C.G.), 011025 Bucharest, Romania; Oregon Health and Science University (D.M.C.), Portland, Oregon 97239; and Division of Clinical Endocrinology (C.J.S.), Department of Medicine, Campus Charite, Mitte, 10117 Berlin, Germany

Address all correspondence and requests for reprints to: Beverly M. K. Biller, Massachusetts General Hospital, Boston, Massachusetts 02114. E-mail:

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 sc 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.