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

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Catabasis Pharmaceuticals

Criteria

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