RANDOMIZED STUDY TO DETERMINE EFFECTS OF SUBCUTANEOUS RECOMBINANT LEPTIN

一项为期16周的随机、盲法、安慰剂对照的平行研究 将大约150名受试者分成3个治疗组(10 mg 和20毫克r-MET-HuLeptin和匹配的安慰剂[安慰剂池 分析])。符合条件的受试者将按91：1的比例随机分配 以下两种给药方案：-10 mg r-Met-HuLeptin/安慰剂 皮下注射，每日一次，每日一次，早上一次；-10毫克 R-Met-HuLeptin/安慰剂皮下注射，每日两次(每日两次) 在早上和晚上)。在每个剂量计划内，受试者将 按2：1的比例随机分配给r-Met-HuLeptin或安慰剂。一个 将使用最小化程序来平衡治疗组在 血红蛋白A的基线(10%和10%)。受试者将被蒙在鼓里 治疗16周，之后可能会有开放标签 维修研究。

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 daily (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.