Pilot Study To Assess CAT-2003 in Patients With Hyperlipidemia

Status:	Completed
Conditions:	High Cholesterol, High Cholesterol, Metabolic
Therapuetic Areas:	Cardiology / Vascular Diseases, Pharmacology / Toxicology
Healthy:	No
Age Range:	18 - 69
Updated:	1/1/2014
Start Date:	July 2013
End Date:	December 2013
Contact:	Joanne Donovan, MD, PhD
Email:	clinical@catabasis.com
Phone:	617-349-1971

A Randomized, Double-Blind, Placebo-Controlled Pilot Study to Assess the Safety, Efficacy and Pharmacodynamics of CAT-2003 Alone and In Combination With A Statin in Patients With Hyperlipidemia (PATHWAYS I)

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.

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

We found this trial at

sites

Clinical Trial Facility in Raleigh North Carolina

Raleigh, North Carolina 27607

from

Raleigh, NC