Pilot Study To Assess CAT-2003 in Patients With Hyperlipidemia

Completed · Phase 2 · Has a placebo group

Conditions studied: Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia

In brief

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.

Key facts

Study ID

NCT01912560

Run by

Catabasis Pharmaceuticals

People needed

99

Starts

2013-07-01

Expected to finish

2013-12-01

Last updated by the study team

2016-07-28

Who can join

Age: 18 and older, up to 69. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Muscle Shoals, Alabama, United States
• Study site — Los Angeles, California, United States
• Study site — Jacksonville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Winter Park, Florida, United States
• Study site — Kansas City, Kansas, United States
• Study site — Louisville, Kentucky, United States
• Study site — Auburn, Maine, United States
• Study site — Raleigh, North Carolina, United States
• Study site — Raleigh, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Sainte-Foy, Quebec, Canada

Full record on ClinicalTrials.gov

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