Merck & Co. has reported positive fifty-two week results of a two-year Phase III study of taranabant, which showed that patients experienced statistically significant weight loss when taking the drug in combination with diet and exercise.
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In this study, patients taking taranabant 2mg experienced more than double the amount of weight loss at 52 weeks compared to patients treated with placebo. Patients on taranabant 2mg demonstrated a mean weight loss reduction from baseline of 6.6kg or 14.5lbs compared to 2.6kg or 5.7lbs for patients on placebo, which was statistically significant (p<0.001 vs. placebo), at 52 weeks. Maximum weight loss in this study was achieved by week 36 and was maintained throughout the next 16 weeks of the study in patients taking taranabant 2mg. Patients in all treatment groups were placed on a diet and exercise regimen in addition to therapy or placebo. John Amatruda, vice president of clinical research, metabolic disorders at Merck Research Laboratories, said: "Based on the benefit-risk considerations and the lack of a substantial improvement in the efficacy of taranabant at the 4mg and 6mg doses seen in our clinical program compared to the 2mg dose, we have decided to continue to evaluate taranabant in doses up to and including 2mg in our Phase III studies. We have a robust Phase III clinical program in place, and we look forward to presenting further results later this year."
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