Back to resultsA Study to Assess the Safety and Efficacy of CAT-2054 in Combination With Atorvastatin in Patients With Hypercholesterolemia
Primary Purpose
Hypercholesterolemia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CAT-2054
Placebo
Atorvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolemia
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:
- 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
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Group 1: CAT-2054 or Placebo Dose 1
Group 2: CAT-2054 or Placebo Dose 2
Group 3: CAT-2054 or Placebo Dose 3
Group 4: CAT-2054 or Placebo Dose 4
Arm Description
A run-in phase with 40 mg atorvastatin tablet administered daily for at least 28 days, followed by a 28-day blinded treatment phase with 250 mg CAT-2054 or placebo QD and open label 40 mg atorvastatin tablet administered daily.
A run-in phase with 40 mg atorvastatin tablet administered daily for at least 28 days, followed by a 28-day blinded treatment phase with 400 mg CAT-2054 or placebo QD and open label 40 mg atorvastatin tablet administered daily.
A run-in phase with 40 mg atorvastatin tablet administered daily for at least 28 days, followed by a 28-day blinded treatment phase with 250 mg CAT-2054 or placebo BID and open label 40 mg atorvastatin tablet administered daily.
A run-in phase with 40 mg atorvastatin tablet administered daily for at least 28 days, followed by a 28-day blinded treatment phase with 400 mg CAT-2054 or placebo BID and open label 40 mg atorvastatin tablet administered daily.
Outcomes
Primary Outcome Measures
Percent change in LDL-C from baseline in patients with hypercholesterolemia.
Secondary Outcome Measures
Frequency of adverse events
Safety and tolerability will be assessed for all enrolled patients from the time the patient signs the informed consent through post-treatment follow-up. Safety parameters include physical exam, vital signs, clinical laboratory tests, ECGs and concomitant medications.
Percent change in TG, non-HDL-C, total cholesterol, HDL-C, apoB from baseline in patients with hypercholesterolemia
Full Information
NCT ID
NCT02608697
First Posted
November 11, 2015
Last Updated
June 14, 2017
Sponsor
Catabasis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT02608697
Brief Title
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
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Catabasis Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
153 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1: CAT-2054 or Placebo Dose 1
Arm Type
Experimental
Arm Description
A run-in phase with 40 mg atorvastatin tablet administered daily for at least 28 days, followed by a 28-day blinded treatment phase with 250 mg CAT-2054 or placebo QD and open label 40 mg atorvastatin tablet administered daily.
Arm Title
Group 2: CAT-2054 or Placebo Dose 2
Arm Type
Experimental
Arm Description
A run-in phase with 40 mg atorvastatin tablet administered daily for at least 28 days, followed by a 28-day blinded treatment phase with 400 mg CAT-2054 or placebo QD and open label 40 mg atorvastatin tablet administered daily.
Arm Title
Group 3: CAT-2054 or Placebo Dose 3
Arm Type
Experimental
Arm Description
A run-in phase with 40 mg atorvastatin tablet administered daily for at least 28 days, followed by a 28-day blinded treatment phase with 250 mg CAT-2054 or placebo BID and open label 40 mg atorvastatin tablet administered daily.
Arm Title
Group 4: CAT-2054 or Placebo Dose 4
Arm Type
Experimental
Arm Description
A run-in phase with 40 mg atorvastatin tablet administered daily for at least 28 days, followed by a 28-day blinded treatment phase with 400 mg CAT-2054 or placebo BID and open label 40 mg atorvastatin tablet administered daily.
Intervention Type
Drug
Intervention Name(s)
CAT-2054
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Primary Outcome Measure Information:
Title
Percent change in LDL-C from baseline in patients with hypercholesterolemia.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Frequency of adverse events
Description
Safety and tolerability will be assessed for all enrolled patients from the time the patient signs the informed consent through post-treatment follow-up. Safety parameters include physical exam, vital signs, clinical laboratory tests, ECGs and concomitant medications.
Time Frame
8 weeks
Title
Percent change in TG, non-HDL-C, total cholesterol, HDL-C, apoB from baseline in patients with hypercholesterolemia
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
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:
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
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
Facility Information:
City
Muscle Shoals
State/Province
Alabama
ZIP/Postal Code
35662
Country
United States
City
Huntington Park
State/Province
California
ZIP/Postal Code
90255
Country
United States
City
Lomita
State/Province
California
ZIP/Postal Code
90717
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34601
Country
United States
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33026
Country
United States
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32792
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
City
Auburn
State/Province
Maine
ZIP/Postal Code
04210
Country
United States
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89123
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45246
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005
Country
United States
City
Lyndhurst
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
City
Marion
State/Province
Ohio
ZIP/Postal Code
43302
Country
United States
City
Willoughby Hills
State/Province
Ohio
ZIP/Postal Code
44094
Country
United States
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29485
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77036
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
City
Orem
State/Province
Utah
ZIP/Postal Code
84058
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
City
Olympia
State/Province
Washington
ZIP/Postal Code
98502
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study to Assess the Safety and Efficacy of CAT-2054 in Combination With Atorvastatin in Patients With Hypercholesterolemia
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