title: Effects of once-weekly sustained-release growth hormone: a double-blind, placebo-controlled study in adult growth hormone deficiency.
abstract: 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.
  
  
  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.affiliation: Massachusetts General Hospital, Boston, Massachusetts 02114, USA. bbiller@partners.org
authors.forename: Beverly M K
authors.initials: BM
authors.lastname: Biller
authors.forename: Hyi-Jeong
authors.initials: HJ
authors.lastname: Ji
authors.forename: Hyunji
authors.initials: H
authors.lastname: Ahn
authors.forename: Conrad
authors.initials: C
authors.lastname: Savoy
authors.forename: E Christine
authors.initials: EC
authors.lastname: Siepl
authors.forename: Vera
authors.initials: V
authors.lastname: Popovic
authors.forename: Mihail
authors.initials: M
authors.lastname: Coculescu
authors.forename: Josefine
authors.initials: J
authors.lastname: Roemmler
authors.forename: Catalin
authors.initials: C
authors.lastname: Gavrila
authors.forename: David M
authors.initials: DM
authors.lastname: Cook
authors.forename: Christian J
authors.initials: CJ
authors.lastname: Strasburger
mesh_terms: D015502:Absorptiometry, Photon; D000273:Adipose Tissue / Q000187:drug effects*; D000328:Adult; D000704:Analysis of Variance; D001823:Body Composition / Q000187:drug effects*; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004393:Dwarfism, Pituitary / Q000097:blood / Q000628:therapy*; D005260:Female; D020249:Hormone Replacement Therapy; D019382:Human Growth Hormone / Q000008:administration & dosage / Q000172:deficiency / Q000627:therapeutic use*; D006801:Humans; D007334:Insulin-Like Growth Factor I / Q000378:metabolism; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome
chemical_list: D003692:Delayed-Action Preparations; D019382:Human Growth Hormone; D007334:Insulin-Like Growth Factor I