Pilot Study To Assess 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.
Lipid Metabolism Disorders
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||A Phase 2 Pilot Study to Assess the Safety and Efficacy of CAT-2003 in Patients With Severe Hypertriglyceridemia|
- Percent change from baseline in fasting triglycerides in patients with severe hypertriglyceridemia [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Frequency of adverse events [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||October 2013|
|Estimated Study Completion Date:||May 2014|
|Estimated Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
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: CAT-2003 Drug: Placebo|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01968720
|United States, Florida|
|Miami, Florida, United States, 33143|
|United States, Indiana|
|Indianapolis, Indiana, United States, 46260|
|United States, Maine|
|Auburn, Maine, United States, 04210|
|United States, Ohio|
|Cincinnati, Ohio, United States, 45227|