A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of CAT-2054 in Combination With Atorvastatin in Patients With Hypercholesterolemia
Overview
- Phase
- Phase 2
- Intervention
- CAT-2054
- Conditions
- Hypercholesterolemia
- Sponsor
- Catabasis Pharmaceuticals
- Enrollment
- 153
- Primary Endpoint
- Percent change in LDL-C from baseline in patients with hypercholesterolemia.
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
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
Arms & Interventions
Group 1: CAT-2054 or Placebo Dose 1
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.
Intervention: CAT-2054
Group 1: CAT-2054 or Placebo Dose 1
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.
Intervention: Placebo
Group 1: CAT-2054 or Placebo Dose 1
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.
Intervention: Atorvastatin
Group 2: CAT-2054 or Placebo Dose 2
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.
Intervention: CAT-2054
Group 2: CAT-2054 or Placebo Dose 2
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.
Intervention: Placebo
Group 2: CAT-2054 or Placebo Dose 2
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.
Intervention: Atorvastatin
Group 3: CAT-2054 or Placebo Dose 3
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.
Intervention: CAT-2054
Group 3: CAT-2054 or Placebo Dose 3
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.
Intervention: Placebo
Group 3: CAT-2054 or Placebo Dose 3
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.
Intervention: Atorvastatin
Group 4: CAT-2054 or Placebo Dose 4
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: CAT-2054
Group 4: CAT-2054 or Placebo Dose 4
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: Placebo
Group 4: CAT-2054 or Placebo Dose 4
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: Atorvastatin
Outcomes
Primary Outcomes
Percent change in LDL-C from baseline in patients with hypercholesterolemia.
Time Frame: 4 weeks
Secondary Outcomes
- Frequency of adverse events(8 weeks)
- Percent change in TG, non-HDL-C, total cholesterol, HDL-C, apoB from baseline in patients with hypercholesterolemia(4 weeks)