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Completed

NCT Number: NCT02098278

Pilot Study To Assess CAT-2003 in Patients With Chylomicronemia

The purpose of this study is to assess safety and efficacy of CAT-2003 in patients with chylomicronemia. The study will evaluate the effects of CAT-2003 on fasting total and chylomicron triglyceride levels, as well as postprandial total and chylomicron triglyceride clearance.

This is a single-blind study. All patients will receive placebo for 1 week, and CAT-2003 for 12 weeks during the 13 week treatment period.

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Key information

Conditions

Lipoprotein Lipase Deficiency, Familial Chylomicronemia, Familial Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyslipidemias Genetic Diseases, Inborn Hyperlipidemias Hyperlipoproteinemia Type I Hyperlipoproteinemias Hypertriglyceridemia Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chicoutimi, Quebec, Canada

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Who can participate

Healthy volunteers accepted: No

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

Key Inclusion Criteria:

  • Familial Chylomicronemia (Fasting triglycerides ≥ 880 mg/dL at Screening and documented history of plasma post-heparin LDL activity < 20% of normal or genetic confirmation of homozygosity or compound heterozygosity for loss-of-function mutations in familial chylomicronemia-causing genes) OR
  • Non-familial Chylomicronemia (Fasting triglycerides ≥ 440 mg/dL at Screening and documented history of fasting triglycerides ≥ 880 mg/dL)

Key Exclusion Criteria:

  • History of any major cardiovascular event within 6 months of Screening
  • Type I diabetes mellitus or use of insulin
  • History of pancreatitis within 3 month of Screening

Treatment and study plan

CAT-2003

Drug

Placebo

Drug

Primary outcomes

  1. Percent change from baseline in fasting triglycerides in patients with chylomicronemia

    Time frame: 12 Weeks

Secondary outcomes

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

    Time frame: 12 Weeks

  2. Absolute and percent change from baseline on chylomicron triglyceride clearance

    Time frame: 12 Weeks

  3. Absolute and percent change from baseline in plasma non-HDL-C

    Time frame: 12 Weeks

  4. Frequency of adverse events

    Time frame: 13 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 Chylomicronemia

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 28, 2014
Registry last updated
Jul 21, 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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