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Trial record 1 of 1 for:    kowa 877-301
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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

This study is currently recruiting participants.
See Contacts and Locations
Verified March 2017 by Kowa Research Institute, Inc.
Sponsor:
Information provided by (Responsible Party):
Kowa Research Institute, Inc.
ClinicalTrials.gov Identifier:
NCT03001817
First received: November 29, 2016
Last updated: March 22, 2017
Last verified: March 2017
  Purpose
The purpose of this study is to evaluate the efficacy and safety of K-877 in adult patients with SHTG.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Kowa Research Institute, Inc.:

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

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

Estimated Enrollment: 630
Study Start Date: November 2016
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

Detailed Description:
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.
  Eligibility

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

Inclusion Criteria:

  • Able to understand and willing to comply with all study requirements and procedures throughout the duration of the study and give written informed consent;
  • Aged ≥18 years;
  • Patients receiving statin therapy must meet one of the following criteria:

    • Aged ≥21 years with clinical atherosclerotic cardiovascular disease (ASCVD) (history of acute coronary syndrome or myocardial infarction, stable or unstable angina, coronary 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);
    • 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);
    • 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
    • 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;
  • Patients not currently on statins, must not meet the criteria for statin therapy listed above
  • Fasting TG levels ≥500 mg/dL (5.65 mmol/L) and <2000 mg/dL (22.60 mmol/L) based on the mean of Visit 2 (Week -2) and Visit 3 (Week -1).
  • Normal renal function (i.e., estimated glomerular filtration rate [eGFR] ≥90 mL/min/1.73 m2) at Visit 1 (Week -8 or Week -6);

Exclusion Criteria:

  • 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;
  • Body mass index (BMI) >45 kg/m2 at Visit 1 (Week -8 or Week -6);
  • Patients with type 1 diabetes mellitus;
  • 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);
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03001817

Contacts
Contact: Senior Clinical Research Associate 919-433-1600 Clinical@KowaUS.com

  Show 73 Study Locations
Sponsors and Collaborators
Kowa Research Institute, Inc.
  More Information

Responsible Party: Kowa Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT03001817     History of Changes
Other Study ID Numbers: K-877-301
Study First Received: November 29, 2016
Last Updated: March 22, 2017

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

ClinicalTrials.gov processed this record on June 23, 2017