RANDOMIZED STUDY TO DETERMINE EFFECTS OF SUBCUTANEOUS RECOMBINANT LEPTIN

这是一项为期16周的随机、盲法、安慰剂对照、平行研究，约150名受试者被纳入3个治疗组（10mg和20mg r-met-HuLeptin和匹配的安慰剂[安慰剂合并分析]）。符合条件的受试者将按91:1的比例随机分配到以下两种剂量方案中的一种：- 10mg r-met-HuLeptin/安慰剂注射剂皮下注射，每天1次（早上每日一次）；-每日两次皮下注射10mg r-met-HuLeptin/安慰剂（BID，早晚各一次）。在每个剂量计划中，受试者将按2:1的比例随机分配到r-met-HuLeptin或安慰剂组。将使用最小化程序来平衡血红蛋白A（<10%和>10%）基线的治疗组。受试者将接受为期16周的盲法治疗，随后可能进行开放标签维持研究。

A 16 week radomized, blinded, placebo controlled, parallel study w enrollment of approximately 150 subjects into 3 treatment groups (10mg and 20 mg r-met-HuLeptin and matched placebo [placebo pooled for analysis]). Eligible subjects will be randomized 91:1 ratio to one of the following two dose schedules: - 10mg r-met-HuLeptin/placebo injection given subcutaneously, one dailyu (QD in the morning); - 10mg r-met-HuLeptin/placebo injection given subcutaneously twice daily (BID in the morning and evening). Within each dose schedule subjects will be randomly allocated to r-met-HuLeptin or placebo in a 2:1 ratio. A minimization procedure will be used to balance the treatment groups at baseline for hemoglobin A (<10%and >10%). Subjects will receive blinded treatment for 16 weeks which may be followed by an open label maintenance study.