A Phase 2 interventional study of CAT-2003 and Placebo in Hyperlipidemias, Hypertriglyceridemia and Dyslipidemias, sponsored by Catabasis Pharmaceuticals. Completed at 4 sites in United States. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2015-08-14.
Sponsored by Catabasis Pharmaceuticals · Phase 2, Interventional, and Treatment
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.
1,073 studies on the registry are indexed under Dyslipidemias; 158 are open to participants now.
This study's enrollment of 16 is below the median of 99 across 842 interventional studies indexed under Dyslipidemias.
Browse Dyslipidemias studies →Catabasis Pharmaceuticals is the lead sponsor of 12 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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
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.
Time frame: 4 weeks
Absolute and percent change from baseline on postprandial total and chylomicron triglyceride levels
Time frame: 4 weeks
This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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Catabasis Pharmaceuticals