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

Catabasis Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Metabolic Diseases; Hyperlipidemias; Lipid Metabolism Disorders; Dyslipidemias; Hypertriglyceridemia

Treatments: Drug: Placebo; Drug: CAT-2003

Study type: Interventional

Funder types: Industry

Identifiers

NCT01968720

CAT-2003-202

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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16 participants in 1 patient group

CAT-2003 or Placebo

Experimental group

Description:

All patients will receive placebo for a 14 day treatment period and CAT-2003 for a 28 day treatment period.

Treatment:

Drug: Placebo

Drug: CAT-2003