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

Phase 2

Completed

• Conditions: Hyperlipidemias; Hypertriglyceridemia; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases
• Interventions: Drug: CAT-2003; Drug: Placebo

• Registration Number: NCT01968720
• Lead Sponsor: Catabasis Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-21
• Study First Submitted QC: 2013-10-21
• Study First Posted: 2013-10-24
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2015-07
• Disposition First Submitted: 2015-07-27
• Disposition First Submitted QC: 2015-07-27
• Last Update Submitted: 2015-07-27
• Disposition First Posted: 2015-08-14
• Last Update Posted: 2015-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CAT-2003 or Placebo	CAT-2003	All patients will receive placebo for a 14 day treatment period and CAT-2003 for a 28 day treatment period.
CAT-2003 or Placebo	Placebo	All patients will receive placebo for a 14 day treatment period and CAT-2003 for a 28 day treatment period.

Primary Outcome Measures

Name	Time	Method
Percent change from baseline in fasting triglycerides in patients with severe hypertriglyceridemia	4 weeks

Secondary Outcome Measures

Name	Time	Method
Frequency of adverse events	4 weeks	Safety will be assessed for all enrolled patients from the time the patient signs the informed consent through post-treatment follow-up.; Safety parameters include physical exam, vital signs, clinical laboratory tests, ECGs and concomitant medications.
Absolute and percent change from baseline on postprandial total and chylomicron triglyceride levels	4 weeks