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Abstract: 515 MBX8025, A NOVEL PPARΔ AGONIST: LIPID & METABOLIC EFFECTS IN DYSLIPIDEMIC OVERWEIGHT PATIENTS
Workshop III-2 - Pharmacology and Novel Therapies: PPAR Alpha and Gamma Agonists Abstract: 515 Citation: Atherosclerosis Supplement 2009, Vol. 10, Issue 2
MBX8025, A NOVEL PPARǻ AGONIST: LIPID & METABOLIC EFFECTS IN DYSLIPIDEMIC OVERWEIGHT PATIENTS H Bays1, S Schwartz2, T Littlejohn III3, B Kerzner4, R Krauss5, X Wang6, Y Choi6, D Karpf6, B Roberts6 1
L-MARC Res.Ctr., Louisville, KY; 2DGD Res., San Antonio, TX; 3Piedmont Med.Res., WinstonSalem, NC; 4HealthTrends Res., Baltimore, MD; 5CHORI, Oakland, CA; 6Metabolex Inc., Hayward, CA Objectives: In animals, PPARį agonism improves lipids and decreases insulin resistance, inflammation & hepatic fat. This phase 2 study evaluated the lipid & metabolic effects of MBX8025 (a novel PPARį agonist) with & without atorvastatin (ATV) 20 mg. Methods: A placebo (PBO) controlled, blinded, randomized, multicenter study evaluating 2 doses of MBX8025 in 181 overweight men (waist 38”) & women (waist 33"), aged 52.6-54.9, with baseline mixed dyslipidemia (LDL-C 158-175, TG 194-254, HDL-C 43-46 mg/dL). Subjects received PBO, ATV, MBX8025 (50 or 100 mg) alone, or combined with ATV for 8 weeks.
Results: MBX8025 lowered LDL-C 20% and TG 25-30%, increased HDL-C 10%, & had other favorable lipid & metabolic effects beyond ATV alone (Figure). Small, non-clinically relevant changes were seen in red cell parameters and creatinine. Waistline, % body fat, & insulin resistance trended downward. Conclusions: MBX8025 improved LDL-C, TG & HDL-C, with & without ATV, & was generally well tolerated. The potential of this novel PPARį agent for treating dyslipidemia & other metabolic derangements awaits future clinical trials.
Funding: This study was funded by Metabolex Inc.
MBX8025, A NOVEL PPARǻ AGONIST: LIPID & METABOLIC EFFECTS IN DYSLIPIDEMIC OVERWEIGHT PATIENTS H Bays1, S Schwartz2, T Littlejohn III3, B Kerzner4, R Krauss5, X Wang6, Y Choi6, D Karpf6, B Roberts6 1
L-MARC Res.Ctr., Louisville, KY; 2DGD Res., San Antonio, TX; 3Piedmont Med.Res., WinstonSalem, NC; 4HealthTrends Res., Baltimore, MD; 5CHORI, Oakland, CA; 6Metabolex Inc., Hayward, CA Objectives: In animals, PPARį agonism improves lipids and decreases insulin resistance, inflammation & hepatic fat. This phase 2 study evaluated the lipid & metabolic effects of MBX8025 (a novel PPARį agonist) with & without atorvastatin (ATV) 20 mg. Methods: A placebo (PBO) controlled, blinded, randomized, multicenter study evaluating 2 doses of MBX8025 in 181 overweight men (waist 38”) & women (waist 33"), aged 52.6-54.9, with baseline mixed dyslipidemia (LDL-C 158-175, TG 194-254, HDL-C 43-46 mg/dL). Subjects received PBO, ATV, MBX8025 (50 or 100 mg) alone, or combined with ATV for 8 weeks.
Results: MBX8025 lowered LDL-C 20% and TG 25-30%, increased HDL-C 10%, & had other favorable lipid & metabolic effects beyond ATV alone (Figure). Small, non-clinically relevant changes were seen in red cell parameters and creatinine. Waistline, % body fat, & insulin resistance trended downward. Conclusions: MBX8025 improved LDL-C, TG & HDL-C, with & without ATV, & was generally well tolerated. The potential of this novel PPARį agent for treating dyslipidemia & other metabolic derangements awaits future clinical trials.
Funding: This study was funded by Metabolex Inc.