Pilot Study To Assess CAT-2003 in Patients With Severe Hypertriglyceridemia

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

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-04-30

Brief Summary

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The purpose of this study is to determine the safety and efficacy of multiple doses of CAT-2003 in patients with severe hypertriglyceridemia either naive or refractory to current therapy. The study will evaluate effects of CAT-2003 on fasting and postprandial total triglycerides and chylomicron triglyceride levels in patients with severe hypertriglyceridemia.

This is a single-blind study. All patients will receive placebo for a 14 day treatment period and CAT-2003 for a 28 day treatment period.

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Detailed Description

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Conditions

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Hyperlipidemias Hypertriglyceridemia Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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CAT-2003 or Placebo

All patients will receive placebo for a 14 day treatment period and CAT-2003 for a 28 day treatment period.

Group Type EXPERIMENTAL

CAT-2003

Intervention Type DRUG

Placebo

Intervention Type DRUG

Interventions

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CAT-2003

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Between 18 and 74 years at Screening
* Severe Hypertriglyceridemia (TG ≥ 500 mg/dL). If on lipid lowering therapy including statins, fibrates, and/or omega-3 fatty acids, stable dose for at least 4 weeks prior to Screening
* Body mass index (BMI) ≤ 45 kg/m2