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.
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
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