PATHWAYS I: Pilot Study To Assess CAT-2003 in Patients With Hyperlipidemia

Sponsor

Catabasis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT01912560

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

7.1

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the safety and efficacy of different doses of CAT-2003 in patients with hyperlipidemia when CAT-2003 is taken for 4 weeks. The study will evaluate effects of CAT-2003 on (1) fasting triglycerides and non-HDL-C in patients with moderate hypertriglyceridemia and (2) fasting LDL-C levels in combination with a statin in patients with hypercholesterolemia who are on a statin.

Condition or Disease	Intervention/Treatment	Phase
Dyslipidemia Hypercholesterolemia Hypertriglyceridemia	Drug: CAT-2003 Drug: Placebo Drug: Statin	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

99 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-Blind, Placebo-Controlled Pilot Study to Assess the Safety, Efficacy and Pharmacodynamics of CAT-2003 Alone and In Combination With A Statin in Patients With Hyperlipidemia (PATHWAYS I)

Study Start Date :

Jul 1, 2013

Actual Primary Completion Date :

Dec 1, 2013

Actual Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CAT-2003 or Placebo Dose 1 Daily for 28 days in patients with moderate hypertriglyceridemia	Drug: CAT-2003 Drug: Placebo
Experimental: CAT-2003 or Placebo Dose 2 Daily for 28 days in patients with moderate hypertriglyceridemia	Drug: CAT-2003 Drug: Placebo
Experimental: CAT-2003 or Placebo Dose 3 Daily for 28 days in patients with moderate hypertriglyceridemia	Drug: CAT-2003 Drug: Placebo
Experimental: CAT-2003 or Placebo Dose 4 Daily for 28 days in patients with hypercholesterolemia who are on a statin	Drug: CAT-2003 Drug: Placebo Drug: Statin All patients being treated with a stable dose of a statin prior to enrollment continue on their dosing regimen.

Outcome Measures

Primary Outcome Measures

Absolute and percent change from baseline in plasma triglycerides in patients with hypertriglyceridemia [4 weeks]
Absolute and percent change from baseline in plasma low density lipoprotein-cholesterol in patients with hypercholesterolemia [4 weeks]

Secondary Outcome Measures

Absolute and percent change from baseline in plasma non-high-density lipoprotein cholesterol [4 weeks]
Pharmacodynamic effects of CAT-2003 on other lipid biomarkers in patients with hyperlipidemia [4 weeks]
Frequency of adverse events [4 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 69 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Between 18 and 69 years at Screening
Hypertriglyceridemia (TG ≥ 200 mg/dL and < 500 mg/dL and non-HDL-C ≥ 100 mg/dL and < 220 mg/dL) OR
Hypercholesterolemia (LDL-C ≥ 100 mg/dL and < 190 mg/dL and TG value < 200 mg/dL) plus a stable dose of statin for at least 4 weeks prior to Screening.
Body mass index (BMI) ≤ 45 kg/m2

Exclusion Criteria:

History of any major cardiovascular event within 6 months of Screening
Type I diabetes mellitus
Any condition that may predispose the patient to secondary hyperlipidemia, such as uncontrolled hypothyroidism
Any statin at the highest approved dose
Non-statin lipid-altering drugs other than cholesterol absorption inhibitors.
Active peptic ulcer disease or a history of muscle disease or myopathy

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Muscle Shoals	Alabama	United States	35662
2	Los Angeles	California	United States	90057
3	Jacksonville	Florida	United States	32223
4	Miami	Florida	United States	33143
5	Winter Park	Florida	United States	32792
6	Kansas City	Kansas	United States	66160
7	Louisville	Kentucky	United States	40213
8	Auburn	Maine	United States	04120
9	Raleigh	North Carolina	United States	27609
10	Raleigh	North Carolina	United States	27612
11	Cincinnati	Ohio	United States	45219
12	Cincinnati	Ohio	United States	45227
13	Cincinnati	Ohio	United States	45246
14	Sainte-Foy	Quebec	Canada	G1V 4M6