effect of pegylated recombinant human leptin (PEG-OB) on weight loss and inflammatory status in obese subjects

OBJECTIVE: To investigate whether weekly subcutaneous administration of 60 mg of long-acting pegylated human leptin (PEG-OB) for 8 weeks was able to influence weight loss, metabolic profile and inflammatory status of obese subjects on a mildly hypoenergetic diet (deficit: 3.2 MJ/day). DESIGN: A prospective, randomized, double-blind and placebo-controlled single-center trial. SUBJECTS: Twenty-eight healthy, obese subjects (16 women, 12 men; age 22-65 y; body mass index 27.7-38.7 kg/m2). MEASUREMENTS: Bodyweight, metabolic profile (including lipids), C-reactive protein (CRP) and soluble TNF α-receptor (sTNF-R) 55 and 75 levels. RESULTS: At the end of the study no significant differences in the delta or percentage weight loss between the placebo (n=14) and PEG-OB (n=14) groups was observed. Also the changes in metabolic profile, CRP, sTNF-R55 and R75 concentrations between the two groups after 8 weeks of treatment did not differ. CONCLUSION: Weekly injection of 60 mg PEG-OB did not lead to additional weight loss after 8 weeks of treatment. Furthermore, PEG-OB administration did not affect the changes in metabolic profile and the inflammatory status of obese subjects.