Clinical Trial: Assess the Safety and Efficacy of NKPL66 (CaPre™) in the Treatment of Mild-to-high Hypertriglyceridemia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized Open-label Dose-ranging, Multi-center Trial to Assess the Safety and Efficacy of NKPL66(CaPre™) in the Treatment of Mild-to-high Hypertriglyceridemia

Brief Summary: To evaluate the efficacy of 0.5, 1.0, 2.0 and 4.0 g/ day of CaPre™ in reducing fasting plasma serum triglycerides over a four week period in patients with mild-to-high hypertriglyceridemia as compared to the standard of care alone.

Detailed Summary:

The data generated from preclinical studies, as well as data accumulated from preclinical and clinical studies conducted with the precursor of CaPre™, NKO® , a natural health product (NPN: 80006416), have shown that CaPre™ is a safe product and well tolerated. In addition, there are preclinical data demonstrating that CaPre™ is effective in reducing circulating plasma concentrations of triglycerides. This effect is also accompanied by the regulation of other blood lipids, glucose tolerance and inflammatory biomarkers. These studies have been conducted in several preclinical adult phenotypes: (1) Healthy Sprague-Dawley (SD) rats, (2) obese and dyslipidemic Zucker Diabetic Fatty (ZDF) rats and(3-5) in three distinct murine phenotypes (normal wild-type C57BL/6, human ApoA-I transgenic mice and homozygous LDL-receptor knockout).

As the prevalence of cardiometabolic disorders progressively increase over the years, it is expected that there will be an augmentation in the necessity for new anti-dyslipidemic medications that can most importantly be added in combination to other treatments. Current treatment methods address a specific target indication, but do not offer complete management of dyslipidemia.

We are now left with the option to either inadequately treat patients suffering from cardiovascular and metabolic disorders or, to prescribe combination treatments hoping to address the risk factors while mitigating their known side effects. A treatment gap exists since there is no medication that increases HDL-cholesterol and reduces triglycerides while reducing LDL-cholesterol without side effects.

At present there is a need to assess the effectiveness of CaPre™ in reducing triglycerides in patients with high hypertriglyceridemia. The current study w
Sponsor: Acasti Pharma Inc.

Current Primary Outcome: Percent change in fasting blood circulating serum TGs [ Time Frame: Between baseline and 4 weeks of treatment. ]

The percent change in fasting blood circulating serum TGs between baseline and 4 weeks of treatment.


Original Primary Outcome: Percent change in fasting blood circulating serum TGs [ Time Frame: Between baseline and 4 and 8 weeks of treatment. ]

The percent change in fasting blood circulating serum TGs between baseline and 4 and 8 weeks of treatment.


Current Secondary Outcome:

  • Absolute change in fasting plasma TGs [ Time Frame: Baseline, Week 4 and Week 8 ]
    Absolute change in fasting plasma TGs;
  • Patients achieving target TG fasting plasma levels [ Time Frame: Baseline ]
    Percentage (%) of patients achieving target TG fasting plasma levels (TG<1.7 mmol/L);
  • Change in fasting plasma LDL-C, VLDL-C, HDL-C, total cholesterol, hs-CRP and non-HDL [ Time Frame: Between baseline and 4 and 8 weeks of treatment ]
    Absolute change in fasting plasma LDL-C, VLDL-C, HDL-C, total cholesterol, hs-CRP and non-HDL
  • Change in fasting plasma concentrations of LDL-C, VLDL-C, HDL-C, total cholesterol, hs-CRP and non-HDL [ Time Frame: Between baseline and 4 and 8 weeks of treatment ]
    Percentage (%) change in fasting plasma concentrations of LDL-C, VLDL-C, HDL-C, total cholesterol, hs-CRP and non-HDL;
  • Calculated ratios [ Time Frame: The percent change in fasting blood circulating serum TGs Between baseline and 4 and 8 weeks of treatment. ]

    Calculated Ratios:

    1. Total cholesterol : HDL-C
    2. LDL-C : HDL-C
    3. TGs : HDL-C
  • Change in fasting plasma concentrations of biomarkers [ Time Frame: Between baseline and 4 and 8 weeks of treatment ]

    Absolute and percent (%) change in fasting plasma concentrations of biomarkers;

    1. Glycated Hemoglobin (HbA1c)
    2. Glucose
    3. Creatinine phosphokinase (CPK)


Original Secondary Outcome: Same as current

Information By: Acasti Pharma Inc.

Dates:
Date Received: January 19, 2012
Date Started: December 2011
Date Completion:
Last Updated: January 7, 2014
Last Verified: January 2014