EVAL WT LOSS EFFECTS OF RECOMB METHIONYL HUMAN LEPTIN IN OBESE SUBJECTS

$42,739M01FY2000RRNIH

Tufts Medical Center, Boston MA

Investigators

Linked publications & trials

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Abstract

This is a phase II, randomized, placebo-controlled study to evaluate weight loss effects after induction with r-metHuLeptin. All eligible subjects will receive 10 mg subcutaneous injections of r-metHuLeptin, twice daily (10-14 hours apart, once in the morning and once in the evening) for 4 weeks. Participants will be taught to self inject by day 3. Subjects who remain eligible after the induction period will be randomized and will receive 10 mg subcutaneous injections, twice daily, of either r-metHuLeptin or placebo for approximately 24 weeks. This study is expected to last for approximately 9 months and participants will be monitored with physical exams, dietary intervention, body composition, and with a disease specific health related quality of life questionnaire.

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