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|
|Actual Primary Completion Date :||April 2014|
|Actual 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|