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ARTICLE | Clinical News

GFT505: Phase II data

December 7, 2009 8:00 AM UTC

In the 28-day, double-blind, international Phase IIa GFT505-2083 trial in 97 pre-diabetics with atherogenic dyslipidemia and abdominal obesity, 80 mg/day oral GFT505 met the co-primary endpoints and multiple secondary endpoints. On the co-primary endpoints, GFT505 significantly reduced plasma triglycerides by 21% compared with placebo (p=0.0027) and increased HDL-C levels by 9% compared with placebo (p=0.003).

GFT505 also met several secondary endpoints, including significantly reducing pro-atherosclerotic apolipoproteins APOCIII and APOB (p=0.04 and p=0.02, respectively) and significantly increasing plasma levels of anti-atherosclerotic APOA1 and APOA2 (p=0.002 and p<0.0001, respectively). The compound also significantly decreased alanine transaminase (ALT) and gamma-glutamyltransferase (GGT) vs. placebo (p=0.02 and p<0.0001, respectively) and reduced acute phase inflammation markers fibrinogen and haptoglobin compared with placebo (p=0.045 and p=0.009, respectively). ...