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Effects of once-weekly sustained-release growth hormone: a double-blind, placebo-controlled study in adult growth hormone deficiency.

Author(s): Biller BM, Ji HJ, Ahn H, Savoy C, Siepl EC, Popovic V, Coculescu M, Roemmler J, Gavrila C, Cook DM, Strasburger CJ

Affiliation(s): Massachusetts General Hospital, Boston, Massachusetts 02114, USA. bbiller@partners.org

Publication date & source: 2011-06, J Clin Endocrinol Metab., 96(6):1718-26. Epub 2011 Mar 16.

Publication type: Randomized Controlled Trial; Research Support, Non-U.S. Gov't

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.

Page last updated: 2011-12-09

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