Pilot Study To Assess CAT-2003 in Patients With Hyperlipidemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2013-12-31

Brief Summary

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The purpose of this study is to determine the safety and efficacy of different doses of CAT-2003 in patients with hyperlipidemia when CAT-2003 is taken for 4 weeks. The study will evaluate effects of CAT-2003 on (1) fasting triglycerides and non-HDL-C in patients with moderate hypertriglyceridemia and (2) fasting LDL-C levels in combination with a statin in patients with hypercholesterolemia who are on a statin.

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Detailed Description

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Conditions

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Dyslipidemia Hypercholesterolemia Hypertriglyceridemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CAT-2003 or Placebo Dose 1

Daily for 28 days in patients with moderate hypertriglyceridemia

Group Type EXPERIMENTAL

CAT-2003

Intervention Type DRUG

Placebo

Intervention Type DRUG

CAT-2003 or Placebo Dose 2

Daily for 28 days in patients with moderate hypertriglyceridemia

Group Type EXPERIMENTAL

CAT-2003

Intervention Type DRUG

Placebo

Intervention Type DRUG

CAT-2003 or Placebo Dose 3

Daily for 28 days in patients with moderate hypertriglyceridemia

Group Type EXPERIMENTAL

CAT-2003

Intervention Type DRUG

Placebo

Intervention Type DRUG

CAT-2003 or Placebo Dose 4

Daily for 28 days in patients with hypercholesterolemia who are on a statin

Group Type EXPERIMENTAL

CAT-2003

Intervention Type DRUG

Placebo

Intervention Type DRUG

Statin

Intervention Type DRUG

All patients being treated with a stable dose of a statin prior to enrollment continue on their dosing regimen.

Interventions

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CAT-2003

Intervention Type DRUG

Placebo

Intervention Type DRUG

Statin

All patients being treated with a stable dose of a statin prior to enrollment continue on their dosing regimen.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Between 18 and 69 years at Screening
* Hypertriglyceridemia (TG ≥ 200 mg/dL and \< 500 mg/dL and non-HDL-C ≥ 100 mg/dL and \< 220 mg/dL) OR
* Hypercholesterolemia (LDL-C ≥ 100 mg/dL and \< 190 mg/dL and TG value \< 200 mg/dL) plus a stable dose of statin for at least 4 weeks prior to Screening.
* Body mass index (BMI) ≤ 45 kg/m2

Exclusion Criteria

* History of any major cardiovascular event within 6 months of Screening
* Type I diabetes mellitus
* Any condition that may predispose the patient to secondary hyperlipidemia, such as uncontrolled hypothyroidism
* Any statin at the highest approved dose
* Non-statin lipid-altering drugs other than cholesterol absorption inhibitors.
* Active peptic ulcer disease or a history of muscle disease or myopathy

Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No