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

Phase 2

Completed

• Conditions: Hypercholesterolemia
• Interventions: Drug: CAT-2054; Drug: Placebo; Drug: Atorvastatin

• Registration Number: NCT02608697
• Lead Sponsor: Catabasis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-11-11
• Study First Submitted QC: 2015-11-18
• Study First Posted: 2015-11-20
• Primary Completion: 2016-05
• Study Completion: 2016-06
• Status Verified: 2017-06
• Disposition First Submitted: 2017-06-14
• Disposition First Submitted QC: 2017-06-14
• Last Update Submitted: 2017-06-14
• Disposition First Posted: 2017-06-20
• Last Update Posted: 2017-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: CAT-2054 or Placebo Dose 1	Placebo	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.
Group 1: CAT-2054 or Placebo Dose 1	Atorvastatin	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.
Group 2: CAT-2054 or Placebo Dose 2	CAT-2054	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.
Group 2: CAT-2054 or Placebo Dose 2	Placebo	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.
Group 3: CAT-2054 or Placebo Dose 3	Placebo	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.
Group 4: CAT-2054 or Placebo Dose 4	Placebo	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.
Group 4: CAT-2054 or Placebo Dose 4	Atorvastatin	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.
Group 1: CAT-2054 or Placebo Dose 1	CAT-2054	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.
Group 3: CAT-2054 or Placebo Dose 3	CAT-2054	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.
Group 4: CAT-2054 or Placebo Dose 4	CAT-2054	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.
Group 2: CAT-2054 or Placebo Dose 2	Atorvastatin	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.
Group 3: CAT-2054 or Placebo Dose 3	Atorvastatin	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.

Primary Outcome Measures

Name	Time	Method
Percent change in LDL-C from baseline in patients with hypercholesterolemia.	4 weeks

Secondary Outcome Measures

Name	Time	Method
Frequency of adverse events	8 weeks	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	4 weeks