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news.Obecure has launched a phase II clinical trial to evaluate the efficacy of the company's cardiovascular drug candidate in improving the plasma lipid profiles of patients treated with simvastatin.
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“It is believed that a low fat diet can improve the cholesterol lowering effect of statin therapy in dyslipidemic patients. We believe that OBE101’s anti-fat craving effect may provide the same benefit and assist patients taking Simvastatin, and further lower their plasma lipids,” said Dr Yaffa Beck, CEO of Obecure.
The study will enroll about 30 subjects who are stably treated with simvastatin and randomize them into one of two treatment groups: a treatment arm, which will be administered the drug twice daily, and a control arm which will receive a placebo.
The primary endpoints for the study include a statistically significant reduction in LDL levels from baseline in treated patients, as compared to placebo, as well as a significant difference between treatment and placebo in the percentage of patients whose LDL levels are reduced by greater than 10%.
Israel-based Obecure is currently conducting two additional phase II studies using the company’s OBE101 drug candidate in the area of weight management.