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Study to Evaluate the Efficacy and Safety of K-877 in Adult Patients With Fasting High Triglyceride Levels and Normal Renal Function

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ClinicalTrials.gov Identifier: NCT03001817
Recruitment Status : Active, not recruiting
First Posted : December 23, 2016
Last Update Posted : December 18, 2018
Sponsor:
Information provided by (Responsible Party):
Kowa Research Institute, Inc.

Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of K-877 in adult patients with fasting high triglyceride levels ≥500 mg/dL and <2000 mg/dL and normal renal function.

Condition or disease Intervention/treatment Phase
Severe Hypertriglyceridemia Drug: K-877 Drug: Fenofibrate Drug: Placebo (for K-877) Drug: Placebo (for Fenofibrate) Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 630 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Actual Study Start Date : November 28, 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Triglycerides
Drug Information available for: Fenofibrate

Arm Intervention/treatment
Placebo Comparator: 12 Week Efficacy
K-877 or placebo comparator twice daily for 12 weeks
Drug: K-877
Drug: Placebo (for K-877)
Active Comparator: 40 Week Extension
K-877 with placebo matching fenofibrate or fenofibrate with placebo matching K-877 for 40 weeks
Drug: K-877
Drug: Fenofibrate
Drug: Placebo (for K-877)
Drug: Placebo (for Fenofibrate)



Primary Outcome Measures :
  1. Percent change of Fasting Triglyceride(TG) Levels [ Time Frame: 12 Weeks ]
    Percent change in fasting Triglyceride(TG) levels from baseline to Week 12


Secondary Outcome Measures :
  1. Percent change of Fasting TG Levels [ Time Frame: 52 Weeks ]
    Percent change in fasting TG levels from baseline to Week 52

  2. Percent Change of Other Lipid Parameters [ Time Frame: 12 weeks, and 52 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Able to understand and willing to comply with all study requirements and procedures throughout the duration of the study and give written informed consent;
  2. Aged ≥18 years;
  3. Patients receiving moderate- or high-intensity statin therapy must meet one of the following criteria¹ unless they have any exceptional conditions (see inclusion criterion 4):

    1. Aged ≥21 years with clinical atherosclerotic cardiovascular disease (ASCVD) (history of acute coronary syndrome or myocardial infarction, stable or unstable angina, coronary or other arterial revascularization, stroke, transient ischemic attack [TIA] presumed to be of atherosclerotic origin, or peripheral arterial disease or revascularization), on a high-intensity statin (or moderate-intensity statin if not a candidate for high-intensity statin due to safety concerns);
    2. Aged ≥21 years with a history of LDL-C ≥190 mg/dL, which is not due to secondary modifiable causes, on a high-intensity statin (or moderate-intensity statin if not a candidate for high-intensity statin due to safety concerns);
    3. Aged 40 to 75 years, inclusive, without clinical ASCVD but with diabetes and a history of LDL-C of 70 to 189 mg/dL, inclusive, on a moderate- or high-intensity statin; or
    4. Aged 40 to 75 years, inclusive, without clinical ASCVD or diabetes, with a history of LDL-C of 70 to 189 mg/dL, inclusive, with estimated 10-year risk for ASCVD of ≥7.5% by the Pooled Cohort Equation on a moderate- or high-intensity statin;
  4. Patients currently on a low-intensity statin or not on a statin, must meet one of the following criteria:

    1. Patient does not meet any criteria for moderate- or high-intensity statin therapy listed above (see inclusion criteria, criterion 3.a. through 3.d.);
    2. Patient does meet one or more criteria for moderate- or high-intensity statin therapy listed above (see inclusion criteria 3.a. through 3.d.); but the patient is not a candidate for moderate or high-intensity statin due to safety concerns, or due to partial or complete statin intolerance; or
    3. Patient does meet one or more criteria for moderate- or high intensity statin therapy listed above (see inclusion criteria 3.b. through 3.d., except for 3.a.); but the patient is not a candidate for moderate or high-intensity statin for primary prevention after considering individual risk evaluation (e.g. current LDL C ≤70mg/dL) and patient preference;

Exclusion Criteria:

  1. Patients who will require lipid-altering treatments other than study drugs (K-877 or fenofibrate), statins, ezetimibe, or PCSK9 inhibitors during the course of the study. These include bile acid sequestrants, non-study fibrates, niacin (>100 mg/day), omega-3 fatty acids (>1000 mg/day), or any supplements used to alter lipid metabolism including, but not limited to, red rice yeast supplements, garlic supplements, soy isoflavone supplements, sterol/stanol products, or policosanols;
  2. Body mass index (BMI) >45 kg/m2 at Visit 1 (Week -8 or Week -6);
  3. Patients with type 1 diabetes mellitus;
  4. Patients with newly diagnosed (within 3 months prior to Visit 2 [Week -2]) or poorly controlled type 2 diabetes mellitus (T2DM), defined as hemoglobin A1c >9.5% at Visit 1 (Week -8 or Week -6);

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03001817


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Sponsors and Collaborators
Kowa Research Institute, Inc.

Responsible Party: Kowa Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT03001817     History of Changes
Other Study ID Numbers: K-877-301
First Posted: December 23, 2016    Key Record Dates
Last Update Posted: December 18, 2018
Last Verified: December 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Fenofibrate
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents