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

Completed · Phase 2 · Has a placebo group

Conditions studied: Hypercholesterolemia

In brief

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.

Key facts

Study ID

NCT02608697

Run by

Catabasis Pharmaceuticals

People needed

153

Starts

2015-10-01

Expected to finish

2016-06-01

Last updated by the study team

2017-06-20

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
• 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:
• 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
• 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

You may not qualify if…

• 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

Where it is running

• Study site — Muscle Shoals, Alabama, United States
• Study site — Huntington Park, California, United States
• Study site — Lomita, California, United States
• Study site — Los Angeles, California, United States
• Study site — Brooksville, Florida, United States
• Study site — Hialeah, Florida, United States
• Study site — Jupiter, Florida, United States
• Study site — Pembroke Pines, Florida, United States
• Study site — Winter Park, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Evanston, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Kansas City, Kansas, United States
• Study site — Louisville, Kentucky, United States
• Study site — Auburn, Maine, United States
• Study site — Troy, Michigan, United States
• Study site — Las Vegas, Nevada, United States
• Study site — New York, New York, United States
• Study site — Rochester, New York, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Columbus, Ohio, United States
• Study site — Franklin, Ohio, United States
• Study site — Lyndhurst, Ohio, United States

Full record on ClinicalTrials.gov

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