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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Catabasis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01912560
First received: July 25, 2013
Last updated: March 7, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Dyslipidemia
Hypercholesterolemia
Hypertriglyceridemia
Drug: CAT-2003
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by Catabasis Pharmaceuticals:

Primary Outcome Measures:
  • Absolute and percent change from baseline in plasma triglycerides in patients with hypertriglyceridemia [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Absolute and percent change from baseline in plasma low density lipoprotein-cholesterol in patients with hypercholesterolemia [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Absolute and percent change from baseline in plasma non-high-density lipoprotein cholesterol [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Pharmacodynamic effects of CAT-2003 on other lipid biomarkers in patients with hyperlipidemia [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Frequency of adverse events [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 99
Study Start Date: July 2013
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01912560

Locations
United States, Alabama
Muscle Shoals, Alabama, United States, 35662
United States, California
Los Angeles, California, United States, 90057
United States, Florida
Jacksonville, Florida, United States, 32223
Miami, Florida, United States, 33143
Winter Park, Florida, United States, 32792
United States, Kansas
Kansas City, Kansas, United States, 66160
United States, Kentucky
Louisville, Kentucky, United States, 40213
United States, Maine
Auburn, Maine, United States, 04120
United States, North Carolina
Raleigh, North Carolina, United States, 27609
Raleigh, North Carolina, United States, 27612
United States, Ohio
Cincinnati, Ohio, United States, 45227
Cincinnati, Ohio, United States, 45219
Cincinnati, Ohio, United States, 45246
Canada, Quebec
Sainte-Foy, Quebec, Canada, G1V 4M6
Sponsors and Collaborators
Catabasis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Catabasis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01912560     History of Changes
Other Study ID Numbers: CAT-2003-201
Study First Received: July 25, 2013
Last Updated: March 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Hypertriglyceridemia
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 20, 2014