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Completed

NCT Number: NCT01912560

Pilot Study To Assess CAT-2003 in Patients With Hyperlipidemia

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.

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Key information

Conditions

Dyslipidemia Dyslipidemias Hypercholesterolemia Hyperlipidemias Hypertriglyceridemia Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sainte-Foy, Quebec, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CAT-2003

Drug

Placebo

Drug

Statin

Drug

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

Primary outcomes

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

    Time frame: 4 weeks

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

    Time frame: 4 weeks

Secondary outcomes

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

    Time frame: 4 weeks

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

    Time frame: 4 weeks

  3. Frequency of adverse events

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Catabasis Pharmaceuticals

Industry

Registry information

Official study 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)

Acronym: PATHWAYS I

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jul 31, 2013
Registry last updated
Jul 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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