Weekly subcutaneous pegylated recombinant native human leptin (PEG-OB) administration in obese men.
To assess the biological activity and tolerability of pegylated recombinant native human leptin (PEG-OB), 30 obese men (mean body mass index, 33.9 kg/m2) were randomized to a double-blind treatment with weekly sc injections of 20 mg PEG-OB or placebo for 12 weeks, in addition to a hypocaloric diet (deficit, 2 MJ/day). Body composition, energy expenditure, and metabolic parameters were measured before and after treatment. PEG-OB was generally well tolerated based on adverse event reports, lab values, and vital signs. Weekly sc PEG-OB led to sustained serum concentrations of PEG-OB and leptin throughout treatment. No significant differences in the delta or percent weight loss, percent body fat, sleeping metabolic rate, or respiratory quotient were observed between the PEG-OB and placebo groups. Percent change in serum triglycerides from baseline was significantly correlated with body weight loss in the PEG-OB group, but not in the placebo group. Although larger reductions in serum triglycerides were observed in the PEG-OB group compared with the placebo group, these differences were not statistically significant. We concluded that weekly injection of PEG-OB leads to sustained serum concentration of PEG-OB and leptin throughout the 12-week treatment period and is generally well tolerated. The trends observed in serum triglycerides suggest that a weekly 20-mg sc treatment with PEG-OB may have biological effects in obese men.
Hukshorn
C J
CJ
Nutrition and Toxicology Research Center, NUTRIM, University of Maastricht, The Netherlands.
Saris
W H
WH
Westerterp-Plantenga
M S
MS
Farid
A R
AR
Smith
F J
FJ
Campfield
L A
LA
D000293:Adolescent; D000328:Adult; D001823:Body Composition / Q000187:drug effects; D004311:Double-Blind Method; D004734:Energy Metabolism / Q000187:drug effects; D006801:Humans; D020738:Leptin / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000097:blood / Q000188:drug therapy* / Q000503:physiopathology; D010919:Placebos; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D012449:Safety; D013997:Time Factors; D014280:Triglycerides / Q000097:blood
D020738:Leptin; D010919:Placebos; D011994:Recombinant Proteins; D014280:Triglycerides