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VK2809 in NAFLD: a phase 2 study

VK2809 in NAFLD: a phase 2 study. Design. Follow-up. Placebo (N = 15). NAFLD patients with LDL-C > 110 mg/dL Liver fat content > 8% (MRI-PDFF). 10 mg VK2809 QOD (N = 16). Randomization. 10 mg VK2809 QD (N = 16). Double-Blind Treatment. Screening MRI-PDFF. D 1. W 1. W 4. W 6. W 8.

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VK2809 in NAFLD: a phase 2 study

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  1. VK2809 in NAFLD: a phase 2 study • Design Follow-up Placebo (N = 15) NAFLD patients with LDL-C > 110 mg/dL Liver fat content > 8% (MRI-PDFF) 10 mg VK2809 QOD (N = 16) Randomization 10 mg VK2809 QD (N = 16) Double-Blind Treatment Screening MRI-PDFF D1 W1 W4 W6 W8 W12MRI-PDFF W16MRI-PDFF • VK2809: selected liver-targeted thyroid receptor βagonist • Endpoints • Primary: change in LDL-cholesterol vs placebo • Secondary: change in liver fat by MRI-PDFF • Exploratory: changes in atherogenic lipoproteins VK2809-phase 2 Loomba R, AASLD 2018, Abs. LB4

  2. VK2809 in NAFLD: a phase 2 study Baseline characteristics VK2809-phase 2 Loomba R, AASLD 2018, Abs. LB4

  3. VK2809 in NAFLD: a phase 2 study Placebo-Adjusted % Change in LDL-C at W12 VK280910 mg QOD (N = 15) VK280910 mg QD (N = 16) All VK2809treated (N = 31) Baseline (mg/dl) 150.3 140.4 145.2 0 -5 -10 -15 -20 -25 -30 -35 -23.6%0.0121 -20.2%0.0269 -21.8%0.0061 % Change P-value VK2809-phase 2 Loomba R, AASLD 2018, Abs. LB4

  4. VK2809 in NAFLD: a phase 2 study Relative change in MRI-PDFF liver fat content at W12, % Absolute change in MRI-PDFF liver fat content at W12, % Placebo (N = 11) VK280910 mg QOD (N = 13) VK280910 mg QD (N = 11) All VK2809treated (N = 24) Placebo (N = 11) VK280910 mg QOD (N = 13) VK280910 mg QD (N = 11) All VK2809treated (N = 24) Baseline LFC 13.4% 17.1% 18.1% 17.8% 13.4% 17.1% 18.1% 17.8% 0 0 -10 -2 -20 -4 -30 -6 -40 -8 -50 -10 -60 % change(SD)p vs placebo -0.9%(2.8) -8.9%(6.2)0.011 -10.6%(5.2)0.0025 -9.7%(5.7)0.0019 % change p vs placebo -8.9% -56.5%0.0014 -59.7%0.0003 -58.1%0.0002 • 66.7% of patients treated with VK2809 experienced a > 50% decrease in liver fat content vs 18.2% in placebo-treated patients VK2809-phase 2 Loomba R, AASLD 2018, Abs. LB4

  5. VK2809 in NAFLD: a phase 2 study Change in Lipoprotein(a) at W12, % Change in Apolipoprotein B at W12, % Placebo VK280910 mg QOD VK280910 mg QD Placebo VK280910 mg QOD VK280910 mg QD All VK2809treated All VK2809treated 15.5% 14.9% 20.4% 17.7% 107.3% 112.0% 108.5% 110.2% 0 0 -10 -10 -20 -20 -30 -30 -40 Change p value 4.7% -36.8%0.097 -24.6%0.049 -30.4%0.039 Change p value 0.4% -23.7%0.0021 -17.4%0.020 -20.4%0.0021 VK2809-phase 2 Loomba R, AASLD 2018, Abs. LB4

  6. VK2809 in NAFLD: a phase 2 study Summary of adverse events • Good tolerability and safety • No serious adverse events observed in any arm • No dose-related trends in AEs • Excellent gastro-intestinal tolerability VK2809-phase 2 Loomba R, AASLD 2018, Abs. LB4

  7. VK2809 in NAFLD: a phase 2 study • Summary • VK2809 produced robust reduction in liver fat on MRI-PDFF in NAFLD patients after 12 weeks of oral dosing • Up to 91% of patients dosed with VK2809 experienced a response as demonstrated by liver fat reductions ≥ 30% relative to baseline ; 67% experienced liver fat reductions ≥ 50% • VK2809 produced significant reduction in LDL-C, triglycerides, Apo B, and Lp(a) relative to placebo in NAFLD patients • VK2809 was safe and well-tolerated VK2809-phase 2 Loomba R, AASLD 2018, Abs. LB4

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