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ARTICLE | Clinical News

Cetilistat: Phase III data

November 5, 2012 8:00 AM UTC

The double-blind, Japanese Phase III CCT-002 trial in obese patients with Type II diabetes and dyslipidemia showed that thrice-daily 120 mg cetilistat met the primary endpoint of reducing average body weight from baseline to week 52 vs. placebo (2.8% vs. 1.1%). The partners also said that cetilistat led to greater reductions in HbA1c and LDL-C vs. placebo. Cetilistat was well tolerated in the placebo-controlled trial and in a pair of open-label Phase III safety trials evaluating cetilistat for 24 and 52 weeks, respectively. Based on the results, Takeda submitted an NDA to Japan's Ministry of Health, Labor and Welfare (MHLW) for cetilistat to treat obesity with complications of both Type II diabetes and dyslipidemia. ...