A Study to Assess the Safety and Efficacy of CAT-2054 in Combination With Atorvastatin in Patients With Hypercholesterolemia



Status:Active, not recruiting
Conditions:High Cholesterol
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 74
Updated:4/21/2016
Start Date:October 2015
End Date:June 2016

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A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of CAT-2054 in Combination With Atorvastatin in Patients With Hypercholesterolemia

The purpose of this placebo-controlled, double-blind study is to assess the effect of
several doses of CAT-2054 on LDL-C in hypercholesterolemic patients on a stable dose of
high-intensity statin, and to evaluate the safety and tolerability of different doses of
CAT-2054 for 4 weeks.


Inclusion Criteria:

- Between 18 and 74 years at Screening

- Hypercholesterolemia (LDL-C ≥ 70 mg/dL and < 190 mg/dL) plus a stable dose of statin
for at least 4 weeks prior to Screening

- Satisfies one of the following:

1. Female patients of childbearing potential must have used appropriate and highly
effective contraception (a regimen which results in a failure rate of <1% per
year) with their partners for 4 weeks prior to Screening, and remain compliant
during the treatment phase and until 4 weeks after the last dose of
investigational product

2. Male patients must use an acceptable and highly effective contraceptive method
during the treatment phase and until 4 weeks after the last dose of
investigational product

- Body mass index (BMI) ≤45 kg/m2

Exclusion Criteria:

- History of any major cardiovascular event (stroke, TIA, MI, PTCI, CABG,
hospitalization due to heart failure) within 6 months of Screening

- Type I diabetes mellitus or use of insulin

- Active peptic ulcer disease or a history of muscle disease or myopathy
We found this trial at
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420 West 12th Avenue
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Huntington Park, California 90255
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Mount Pleasant, South Carolina 29464
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Summerville, South Carolina 29485
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