Weekly subcutaneous pegylated recombinant native human leptin (PEG-OB) administration in obese men.

Abstract

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.

• Authors: C J Hukshorn, W H Saris, M S Westerterp-Plantenga, A R Farid, F J Smith, L A Campfield
• Journal: The Journal of clinical endocrinology and metabolism (J Clin Endocrinol Metab) Vol. 85 Issue 11 Pg. 4003-9 (Nov 2000) ISSN: 0021-972X [Print] United States
• PMID: 11095423 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Leptin
• Placebos
• Recombinant Proteins
• Triglycerides

Topics

• Adolescent
• Adult
• Body Composition (drug effects)
• Double-Blind Method
• Energy Metabolism (drug effects)
• Humans
• Leptin (adverse effects, blood, therapeutic use)
• Male
• Middle Aged
• Obesity (blood, drug therapy, physiopathology)
• Placebos
• Recombinant Proteins (administration & dosage, adverse effects, therapeutic use)
• Safety
• Time Factors
• Triglycerides (blood)