Clinical trial NCT02608697: A Study to Assess the Safety and Efficacy of CAT-2054 in Combination With Atorvastatin in Patients With Hypercholesterolemia
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of CAT-2054 in Combination With Atorvastatin in Patients With Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypercholesterolemia
Lead sponsor: Catabasis Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-11-20
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percent change in LDL-C from baseline in patients with hypercholesterolemia.
timeFrame: 4 weeks
Secondary outcomes:
measure: Frequency of adverse events
timeFrame: 8 weeks
measure: Percent change in TG, non-HDL-C, total cholesterol, HDL-C, apoB from baseline in patients with hypercholesterolemia
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Muscle Shoals
country: United States
state: Alabama
city: Huntington Park
country: United States
state: California
city: Lomita
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Brooksville
country: United States
state: Florida
city: Hialeah
country: United States
state: Florida
city: Jupiter
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Winter Park
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Evanston
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Kansas City
country: United States
state: Kansas
city: Louisville
country: United States
state: Kentucky
city: Auburn
country: United States
state: Maine
city: Troy
country: United States
state: Michigan
city: Las Vegas
country: United States
state: Nevada
city: New York
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Cincinnati
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Franklin
country: United States
state: Ohio
city: Lyndhurst
country: United States
state: Ohio
city: Marion
country: United States
state: Ohio
city: Willoughby Hills
country: United States
state: Ohio
city: Mount Pleasant
country: United States
state: South Carolina
city: Summerville
country: United States
state: South Carolina
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Orem
country: United States
state: Utah
city: Richmond
country: United States
state: Virginia
city: Olympia
country: United States
state: Washington
Study officials:
References: