Cited by 144Regulation of Appetite and ObesityPharmacology and Obesity TreatmentAdipokines, Inflammation, and Metabolic Diseases

The DOI matches its Crossref record; 21 of the 21 references it cites were found in a registry or an index.

Effect of three treatment schedules of recombinant methionyl human leptin on body weight in obese adults: a randomized, placebo‐controlled trial

Zelissen, P. M. J., Stenlof, K., Lean, M. E. J., Fogteloo, J., Keulen, E. T. P., Wilding, J., Finer, N., Rössner, S., Lawrence, E., Fletcher, C., McCamish, M., on behalf of the author group·2005·Diabetes, Obesity and Metabolism

Abstract

Aim: The aim of this study was to evaluate the effect on body weight and safety of subcutaneously administered recombinant leptin in obese adults and to evaluate whether the timing of recombinant leptin administration influences efficacy. Methods: A randomized, double‐blind, placebo‐controlled, multicentre study was designed, comprising of a 3‐week dietary lead‐in followed by a 12‐week leptin or placebo treatment period. A total of 284 overweight and obese (body mass index 27–37.0 kg/m 2 ) predominantly white (98%) women (66%) and men (34%) with a mean (±s.d.) 46.8 ± 10.4 years of age were randomized into three treatment groups with three matching placebo groups. Recombinant leptin was administered by subcutaneous injection [10 mg/morning, 10 mg/evening or 20 mg/day (10 mg twice daily)]. Patients were counselled at baseline to reduce dietary intake by 2100 kJ/day (500 kcal/day), and dietary advice was reinforced every 2–4 weeks. Results: No statistically significant change in body weight occurred with recombinant leptin treatment compared with placebo treatment in any treatment group. No clinically significant adverse effects were observed with the exception of an increase in injection‐site reactions in patients treated with recombinant leptin (83%) vs. placebo (36%). Conclusions: Administration of recombinant leptin to an overweight and obese population, in addition to a mildly energy‐restricted diet, was not efficacious in terms of weight loss at the doses and schedules studied. The hypothesis that nocturnal administration of recombinant leptin might have a specific effect on weight loss was not supported.

Overview

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Registry

Crossref · 10.1111/j.1463-1326.2005.00468.x

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21 of 21 references verified0 citation errors · 0 not checkable

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  • Administration of recombinant leptin for 12 weeks failed to increase blood pressure in overweight or obese adults.

    “Although the effect of chronic leptin infusion on SNA in humans has not yet been reported, administration of recombinant leptin for 12 weeks failed to increase BP in overweight or obese adults133.”
  • Administration of recombinant leptin for 12 weeks did not raise BP in overweight or obese humans.

    “Zelissen et al.90 reported that administration of recombinant leptin for 12 weeks did not raise BP”

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Metadata

Authors
Zelissen, P. M. J., Stenlof, K., Lean, M. E. J., Fogteloo, J., Keulen, E. T. P., Wilding, J., Finer, N., Rössner, S., Lawrence, E., Fletcher, C., McCamish, M., & on behalf of the author group
Affiliations
  • University Medical Center Utrecht (NL)
  • Glasgow Royal Infirmary (GB)
  • Leiden University Medical Center (NL)
  • Maastricht University Medical Centre (NL)
  • Aintree University Hospital (GB)
  • Luton and Dunstable Hospital (GB)
  • Amgen (United States) (US)
Corresponding author
Zelissen, P. M. J.
Venue
Diabetes, Obesity and Metabolism
Publisher
Wiley
Published
2005-03-18
Volume
7
Issue
6
Pages
755-761
ISSN
  • 1462-8902 (ISSN-L)
  • 1463-1326
OpenAlex
W2065738278
Cited by
144
References
21
Citations by year
2026: 2 · 2025: 9 · 2024: 9 · 2023: 11 · 2022: 8 · 2021: 7 · 2020: 11 · 2019: 2 · 2018: 7 · 2017: 3 · 2016: 6 · 2015: 8 · 2014: 8 · 2013: 8 · 2012: 1
FWCI
1.96
Type
journal article
Language
en
Open access
closed
Locations
  • Diabetes Obesity and Metabolism (publishedVersion)
  • PubMed (publishedVersion)
  • UCL Discovery (University College London) (submittedVersion)
Funders
Amgen
Topics
  • Life Sciences › Neuroscience › Endocrine and Autonomic Systems › Regulation of Appetite and Obesity
  • Health Sciences › Medicine › Pharmacology (medical) › Pharmacology and Obesity Treatment
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Adipokines, Inflammation, and Metabolic Diseases
Keywords
recombinant human leptin, obesity, weight loss, treatment schedule, hypocaloric diet, injection site reactions, overweight adults
MeSH terms
Adult, Energy Intake, Double-Blind Method, Drug Administration Schedule, Female, Humans, Hunger, Injections, Subcutaneous, Lipids, Male, Middle Aged, Obesity, Weight Loss, Anti-Obesity Agents, Leptin

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