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Obecure Recruits First Patient in Phase II Obesity Study in Pre-Menopause Women
9/8/2008 8:59:34 AM
RAMAT GAN, Israel--(BUSINESS WIRE)--Obecure has commenced a Phase II clinical trial to evaluate the efficacy of HistaleanTM in obese patients. This study, encoded BET-207, is a follow-up to the Company's post-hoc findings in a prior Phase II study, suggesting that treatment with a 48 mg/day dose of the drug provides significant weight reduction in obese women up to the age of 50. The current study is a double-blinded, placebo-controlled, multi-center, dose ranging study to confirm the efficacy of a 12 week treatment with the drug in obese but otherwise healthy premenopausal females aged 18-50. The study will randomize about 180 obese women, with a body to mass ratio (BMI) ranging from 30 - 40 kg/m2, into three study arms: 60 women will be treated with 48 mg/day HistaleanTM, 60 women will be treated with 96 mg/day HistaleanTM and 60 women will receive matching placebo. The study will be carried out in about 12 investigation sites in Europe and regulatory approval has already been received in Belgium and the Netherlands.
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