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

Dyslipidemias Clinical Trial

Official title:

A Phase 2 Pilot Study to Assess the Safety and Efficacy of CAT-2003 in Patients With Severe Hypertriglyceridemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01968720
• Other study ID #: CAT-2003-202
• Status: Completed
• Phase: Phase 2
• First received: October 21, 2013
• Last updated: July 27, 2015
• Start date: October 2013
• Est. completion date: April 2014

Study information

• Verified date: July 2015
• Source: Catabasis Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 74 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemias
• Hyperlipidemias
• Hypertriglyceridemia
• Lipid Metabolism Disorders
• Metabolic Diseases

Intervention

Drug:
• CAT-2003

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Catabasis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change from baseline in fasting triglycerides in patients with severe hypertriglyceridemia		4 weeks	No
Secondary	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	Yes
Secondary	Absolute and percent change from baseline on postprandial total and chylomicron triglyceride levels		4 weeks	No