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

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 2,100 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.

[Overweight and obesity; recommendations from the National Health Council]. / Overgewicht en obesitas; een advies van de Gezondheidsraad.

The Health Council of the Netherlands has issued a report on overweight and obesity. These are considered major threats to personal health, the public health care services and economic welfare. Overweight and obesity are no longer considered variations of the norm, but as a disease. As genetically predisposing factors cannot be influenced, major initiatives to contain further deterioration of the problem must be on environmental factors i.e. on macronutrient intake and physical exercise. Special target groups (young people, people of low socioeconomic status and immigrants) need to be defined. Government, health care organisations, industry and the general public should work together to combat overweight and obesity. The chances of success are not predictable but are certainly big enough to justify action.