Pilot Study To Assess CAT-2003 in Patients With Severe Hypertriglyceridemia
Completed · Phase 2 · Has a placebo group
Conditions studied: Hyperlipidemias, Hypertriglyceridemia, Dyslipidemias, Lipid Metabolism Disorders, Metabolic Diseases
In brief
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.
Key facts
- Study ID
- NCT01968720
- Run by
- Catabasis Pharmaceuticals
- People needed
- 16
- Starts
- 2013-10-01
- Expected to finish
- 2014-04-01
- Last updated by the study team
- 2015-08-14
Who can join
Age: 18 and older, up to 74. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Between 18 and 74 years at Screening
- Severe Hypertriglyceridemia (TG ≥ 500 mg/dL). If on lipid lowering therapy including statins, fibrates, and/or omega-3 fatty acids, stable dose for at least 4 weeks prior to Screening
- Body mass index (BMI) ≤ 45 kg/m2
You may not qualify if…
- History of any major cardiovascular event within 6 months of Screening
- Type I diabetes mellitus or use of insulin
- History of pancreatitis
Where it is running
- Study site — Miami, Florida, United States
- Study site — Indianapolis, Indiana, United States
- Study site — Auburn, Maine, United States
- Study site — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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