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

Conditions

• Severe Hypertriglyceridemia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• K-877 — DRUG
• Fenofibrate — DRUG
• Placebo (for K-877) — DRUG
• Placebo (for Fenofibrate) — DRUG

Study Details

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.

Key Dates

Start date

Nov 28, 2016

Status verified

Nov 2022

Primary completion

Jun 24, 2019

Completion

Jun 24, 2019

Study Design

Enrollment

551 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: 12 Week Efficacy
  K-877 or placebo comparator twice daily for 12 weeks
• Active Comparator: 40 Week Extension
  K-877 with placebo matching fenofibrate or fenofibrate with placebo matching K-877 for 40 weeks

Primary Outcome Measure

Percent Change of Fasting Triglyceride(TG) Levels From Baseline to Week 12 [ Time Frame: 12 Weeks ]

Locations (110)

Find similar trials in Birmingham, AL

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