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

Catabasis Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Hypercholesterolemia

Treatments: Drug: Atorvastatin; Drug: CAT-2054; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02608697

CAT-2054-201

Details and patient eligibility

About

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.

Enrollment: 153 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

153 participants in 4 patient groups

Group 1: CAT-2054 or Placebo Dose 1

Experimental group

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.

Treatment:

Drug: Atorvastatin

Drug: Placebo

Drug: CAT-2054

Group 2: CAT-2054 or Placebo Dose 2

Experimental group

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.

Treatment:

Drug: Atorvastatin

Drug: Placebo

Drug: CAT-2054

Group 3: CAT-2054 or Placebo Dose 3

Experimental group

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.

Treatment:

Drug: Atorvastatin

Drug: Placebo

Drug: CAT-2054

Group 4: CAT-2054 or Placebo Dose 4

Experimental group

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.

Treatment:

Drug: Atorvastatin

Drug: Placebo

Drug: CAT-2054