Weekly Subcutaneous Pegylated Recombinant Native Human Leptin (PEG-OB) Administration in Obese Men
Open accessAbstract
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.
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A recent relatively small, randomized, double-blind clinical trial demonstrated that administration of high, pharmacologic doses of pegylated r-metHuLeptin in addition to a hypocaloric diet produced significant suppression of appetite as measured by eating/hunger questionnaires.
“a recent relatively small, randomized, double-blind clinical trial demonstrated that administration of high, pharmacologic doses of pegylated r-metHuLeptin in addition to a hypocaloric diet produced significant suppression of appetite as measured by eating/hunger questionnaires (54)”
From The role of falling leptin levels in the neuroendocrine and metabolic adaptation to short-term starvation in healthy men (2003) · cites this paper as [54]
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Experimental — accuracy not yet measuredLeptin therapy alone has failed to induce significant weight loss or insulin sensitization.
“Indeed, leptin therapy alone has failed to induce significant weight loss or insulin sensitization 149, 150.”
From Inter‐organ communication: a gatekeeper for metabolic health (2019) · cites this paper as [150]
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- Authors
- Hukshorn, C. J., Saris, W. H. M., Westerterp-Plantenga, M. S., Farid, A. R., Smith, F. J., & Campfield, L. A.
- Affiliations
- Maastricht University (NL)
- Colorado State University (US)
- ORCID
- Saris, Wim H. M.
- Venue
- The Journal of Clinical Endocrinology & Metabolism
- Publisher
- The Endocrine Society
- Published
- 2000-11
- Volume
- 85
- Issue
- 11
- Pages
- 4003-4009
- ISSN
- 0021-972X (ISSN-L)
- 1945-7197
- OpenAlex
- W2057919982
- Cited by
- 220
- References
- 30
- Citations by year
- 2026: 3 · 2025: 5 · 2024: 7 · 2023: 10 · 2022: 3 · 2021: 7 · 2020: 3 · 2019: 6 · 2018: 6 · 2017: 6 · 2016: 9 · 2015: 11 · 2014: 12 · 2013: 11 · 2012: 8
- FWCI
- 4.95
- Type
- journal article
- Language
- en
- Open access
- Licence
- other-oa
- Locations
- The Journal of Clinical Endocrinology & Metabolism (publishedVersion)
- PubMed (publishedVersion)
- Research Publications (Maastricht University) (publishedVersion, other-oa)
- Research Publications (Maastricht University) (submittedVersion, other-oa)
- Funders
- F. Hoffmann-La Roche
- Novo Nordisk
- Topics
- Life Sciences › Neuroscience › Endocrine and Autonomic Systems › Regulation of Appetite and Obesity
- Health Sciences › Medicine › Epidemiology › Adipokines, Inflammation, and Metabolic Diseases
- Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
- Keywords
- leptin therapy, obesity, subcutaneous injection, weight loss, hypocaloric diet, serum triglycerides, body composition, energy expenditure, respiratory quotient, drug tolerability, obese men
- MeSH terms
- Adolescent, Adult, Body Composition, Double-Blind Method, Energy Metabolism, Humans, Male, Middle Aged, Obesity, Placebos, Recombinant Proteins, Safety, Time Factors, Triglycerides, Leptin
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