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Completed

NCT Number: NCT01968720

Pilot Study To Assess CAT-2003 in Patients With Severe Hypertriglyceridemia

The purpose of this study is to determine the safety and efficacy of multiple doses of CAT-2003 in patients with severe hypertriglyceridemia either naive or refractory to current therapy. The study will evaluate effects of CAT-2003 on fasting and postprandial total triglycerides and chylomicron triglyceride levels in patients with severe hypertriglyceridemia.

This is a single-blind study. All patients will receive placebo for a 14 day treatment period and CAT-2003 for a 28 day treatment period.

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Key information

Conditions

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

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Miami, Florida, United States

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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 74 years at Screening
  • Severe Hypertriglyceridemia (TG ≥ 500 mg/dL). If on lipid lowering therapy including statins, fibrates, and/or omega-3 fatty acids, stable dose 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 or use of insulin
  • History of pancreatitis

Treatment and study plan

CAT-2003

Drug

Placebo

Drug

Primary outcomes

  1. Percent change from baseline in fasting triglycerides in patients with severe hypertriglyceridemia

    Time frame: 4 weeks

Secondary outcomes

  1. Frequency of adverse events

    Time frame: 4 weeks

    Safety 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.

  2. Absolute and percent change from baseline on postprandial total and chylomicron triglyceride levels

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Catabasis Pharmaceuticals

Industry

Registry information

Official study title

A Phase 2 Pilot Study to Assess the Safety and Efficacy of CAT-2003 in Patients With Severe Hypertriglyceridemia

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 24, 2013
Registry last updated
Aug 14, 2015

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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