Pilot Study To Assess CAT-2003 in Patients With Severe Hypertriglyceridemia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01968720|
Recruitment Status : Completed
First Posted : October 24, 2013
Last Update Posted : August 14, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Hyperlipidemias Hypertriglyceridemia Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases||Drug: CAT-2003 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||A Phase 2 Pilot Study to Assess the Safety and Efficacy of CAT-2003 in Patients With Severe Hypertriglyceridemia|
|Study Start Date :||October 2013|
|Primary Completion Date :||April 2014|
|Study Completion Date :||April 2014|
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|
- Percent change from baseline in fasting triglycerides in patients with severe hypertriglyceridemia [ Time Frame: 4 weeks ]
- Frequency of adverse events [ Time Frame: 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 [ Time Frame: 4 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|