Back to results

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

Primary Purpose

Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

CAT-2003

Placebo

Statin

About this trial

This is an interventional treatment trial for Dyslipidemia

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

CAT-2003 or Placebo Dose 1

CAT-2003 or Placebo Dose 2

CAT-2003 or Placebo Dose 3

CAT-2003 or Placebo Dose 4

Arm Description

Daily for 28 days in patients with moderate hypertriglyceridemia

Daily for 28 days in patients with hypercholesterolemia who are on a statin

Outcomes

Primary Outcome Measures

Absolute and percent change from baseline in plasma triglycerides in patients with hypertriglyceridemia

Absolute and percent change from baseline in plasma low density lipoprotein-cholesterol in patients with hypercholesterolemia

Secondary Outcome Measures

Absolute and percent change from baseline in plasma non-high-density lipoprotein cholesterol

Pharmacodynamic effects of CAT-2003 on other lipid biomarkers in patients with hyperlipidemia

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.

Full Information

NCT ID

NCT01912560

First Posted

July 25, 2013

Last Updated

July 26, 2016

Sponsor

Catabasis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01912560

Brief Title

Pilot Study To Assess CAT-2003 in Patients With Hyperlipidemia

Acronym

PATHWAYS I

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 Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Completed

Study Start Date

July 2013 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Catabasis Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

99 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CAT-2003 or Placebo Dose 1

Arm Type

Experimental

Arm Description

Daily for 28 days in patients with moderate hypertriglyceridemia

Arm Title

CAT-2003 or Placebo Dose 2

Arm Type

Experimental

Arm Description

Daily for 28 days in patients with moderate hypertriglyceridemia

Arm Title

CAT-2003 or Placebo Dose 3

Arm Type

Experimental

Arm Description

Daily for 28 days in patients with moderate hypertriglyceridemia

Arm Title

CAT-2003 or Placebo Dose 4

Arm Type

Experimental

Arm Description

Daily for 28 days in patients with hypercholesterolemia who are on a statin

Intervention Type

Drug

Intervention Name(s)

CAT-2003

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Type

Drug

Intervention Name(s)

Statin

Intervention Description

All patients being treated with a stable dose of a statin prior to enrollment continue on their dosing regimen.

Primary Outcome Measure Information:

Title

Absolute and percent change from baseline in plasma triglycerides in patients with hypertriglyceridemia

Time Frame

4 weeks

Title

Absolute and percent change from baseline in plasma low density lipoprotein-cholesterol in patients with hypercholesterolemia

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Absolute and percent change from baseline in plasma non-high-density lipoprotein cholesterol

Time Frame

4 weeks

Title

Pharmacodynamic effects of CAT-2003 on other lipid biomarkers in patients with hyperlipidemia

Time Frame

4 weeks

Title

Frequency of adverse events

Description

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

69 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

City

Muscle Shoals

State/Province

Alabama

ZIP/Postal Code

35662

Country

United States

City

Los Angeles

State/Province

California

ZIP/Postal Code

90057

Country

United States

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32223

Country

United States

City

Miami

State/Province

Florida

ZIP/Postal Code

33143

Country

United States

City

Winter Park

State/Province

Florida

ZIP/Postal Code

32792

Country

United States

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66160

Country

United States

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40213

Country

United States

City

Auburn

State/Province

Maine

ZIP/Postal Code

04120

Country

United States

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27609

Country

United States

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27612

Country

United States

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45219

Country

United States

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45227

Country

United States

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45246

Country

United States

City

Sainte-Foy

State/Province

Quebec

ZIP/Postal Code

G1V 4M6

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

Pilot Study To Assess CAT-2003 in Patients With Hyperlipidemia

We'll reach out to this number within 24 hrs