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

Status:	Completed
Conditions:	High Cholesterol, Endocrine, Metabolic
Therapuetic Areas:	Cardiology / Vascular Diseases, Endocrinology, Pharmacology / Toxicology
Healthy:	No
Age Range:	18 - 74
Updated:	4/21/2016
Start Date:	October 2013
End Date:	April 2014

A Phase 2 Pilot Study to Assess the Safety and Efficacy of CAT-2003 in Patients With Severe Hypertriglyceridemia

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.

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

Exclusion Criteria:

- History of any major cardiovascular event within 6 months of Screening

- Type I diabetes mellitus or use of insulin

- History of pancreatitis

We found this trial at

sites

Clinical Trial Facility in Cincinnati Ohio

Cincinnati, Ohio

from

Cincinnati, OH