Status:
COMPLETED
Pilot Study To Assess CAT-2003 in Patients With Hyperlipidemia
Lead Sponsor:
Catabasis Pharmaceuticals
Conditions:
Dyslipidemia
Hypercholesterolemia
Eligibility:
All Genders
18-69 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the safety and efficacy of different doses of CAT-2003 in patients with hyperlipidemia when CAT-2003 is taken for 4 weeks. The study will evaluate effects of ...
Eligibility Criteria
Inclusion
- Between 18 and 69 years at Screening
- Hypertriglyceridemia (TG ≥ 200 mg/dL and \< 500 mg/dL and non-HDL-C ≥ 100 mg/dL and \< 220 mg/dL) OR
- Hypercholesterolemia (LDL-C ≥ 100 mg/dL and \< 190 mg/dL and TG value \< 200 mg/dL) plus a stable dose of statin for at least 4 weeks prior to Screening.
- Body mass index (BMI) ≤ 45 kg/m2
Exclusion
- History of any major cardiovascular event within 6 months of Screening
- Type I diabetes mellitus
- Any condition that may predispose the patient to secondary hyperlipidemia, such as uncontrolled hypothyroidism
- Any statin at the highest approved dose
- Non-statin lipid-altering drugs other than cholesterol absorption inhibitors.
- Active peptic ulcer disease or a history of muscle disease or myopathy
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT01912560
Start Date
July 1 2013
End Date
December 1 2013
Last Update
July 28 2016
Active Locations (14)
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1
Muscle Shoals, Alabama, United States, 35662
2
Los Angeles, California, United States, 90057
3
Jacksonville, Florida, United States, 32223
4
Miami, Florida, United States, 33143