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

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Diseases; Dyslipidemias; Lipid Metabolism Disorders; Hyperlipidemias; Hypertriglyceridemia
• Intervention / Treatment: Drug: Placebo; Drug: CAT-2003

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33143
  • Indiana
    • Indianapolis, Indiana, United States, 46260
  • Maine
    • Auburn, Maine, United States, 04210
  • Ohio
    • Cincinnati, Ohio, United States, 45227

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CAT-2003 or Placebo; All patients will receive placebo for a 14 day treatment period and CAT-2003 for a 28 day treatment period.	Drug: Placebo; Drug: CAT-2003

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent change from baseline in fasting triglycerides in patients with severe hypertriglyceridemia	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of adverse events	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.	4 weeks
Absolute and percent change from baseline on postprandial total and chylomicron triglyceride levels		4 weeks

Collaborators and Investigators

• Sponsor: Catabasis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: October 21, 2013
• First Submitted That Met QC Criteria: October 21, 2013
• First Posted (Estimate): October 24, 2013

Study Record Updates

• Last Update Posted (Estimate): August 14, 2015
• Last Update Submitted That Met QC Criteria: July 27, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Dyslipidemias; Hyperlipidemias; Hypertriglyceridemia; Metabolic Diseases; Lipid Metabolism Disorders
• Other Study ID Numbers: CAT-2003-202