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

Hypercholesterolemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02608697
• Other study ID #: CAT-2054-201
• Status: Completed
• Phase: Phase 2
• First received: November 11, 2015
• Last updated: June 14, 2017
• Start date: October 2015
• Est. completion date: June 2016

Study information

• Verified date: June 2017
• Source: Catabasis Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: June 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• CAT-2054

• Placebo

• Atorvastatin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Catabasis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change in LDL-C from baseline in patients with hypercholesterolemia.		4 weeks
Secondary	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.	8 weeks
Secondary	Percent change in TG, non-HDL-C, total cholesterol, HDL-C, apoB from baseline in patients with hypercholesterolemia		4 weeks