First Data From Leptin Phase I Reported

17 June 1997

Amgen has reported that leptin appears to cause weight loss in humansand will now enter Phase II clinical trials to further evaluate its safety and efficacy as a treatment for obesity.

The preliminary study involved 165 male and female subjects with a broad range of weight categories and no other medical complications. Leptin was administered by subcutaneous injection, at a range of doses, for up to 90 days. All patients were given exercise and nutrition counselling.

Among all the subjects who completed at least 28 days of the study, 19% of the placebo group lost at least two kilograms, compared to 30%-45% of subjects treated with leptin at doses which will be taken forward into future studies. 30 patients on these doses of leptin who completed the full 90-day course lost a mean of two to four kilograms, compared to a mean reduction of 1.5 kilos in the placebo group.

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