Pilot Study To Assess CAT-2003 in Patients With Chylomicronemia
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|ClinicalTrials.gov Identifier: NCT02098278|
Recruitment Status : Completed
First Posted : March 28, 2014
Last Update Posted : July 21, 2016
The purpose of this study is to assess safety and efficacy of CAT-2003 in patients with chylomicronemia. The study will evaluate the effects of CAT-2003 on fasting total and chylomicron triglyceride levels, as well as postprandial total and chylomicron triglyceride clearance.
This is a single-blind study. All patients will receive placebo for 1 week, and CAT-2003 for 12 weeks during the 13 week treatment period.
|Condition or disease||Intervention/treatment||Phase|
|Lipoprotein Lipase Deficiency, Familial Hyperlipoproteinemia Type I Chylomicronemia, Familial Hypertriglyceridemia||Drug: CAT-2003 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 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 Chylomicronemia|
|Study Start Date :||March 2014|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||April 2015|
Experimental: CAT-2003 or Placebo
All patients will receive placebo for 1 week, and CAT-2003 for 12 weeks during the 13 week treatment period.
- Percent change from baseline in fasting triglycerides in patients with chylomicronemia [ Time Frame: 12 Weeks ]
- Absolute and percent change from baseline on postprandial total and chylomicron triglyceride levels [ Time Frame: 12 Weeks ]
- Absolute and percent change from baseline on chylomicron triglyceride clearance [ Time Frame: 12 Weeks ]
- Absolute and percent change from baseline in plasma non-HDL-C [ Time Frame: 12 Weeks ]
- Frequency of adverse events [ Time Frame: 13 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): NCT02098278
|Chicoutimi, Quebec, Canada, G7H 7K9|
|Quebec City, Quebec, Canada, G1V 4M6|