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Pilot Study To Assess CAT-2003 in Patients With Chylomicronemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02098278
Recruitment Status : Completed
First Posted : March 28, 2014
Last Update Posted : July 21, 2016
Sponsor:
Information provided by (Responsible Party):
Catabasis Pharmaceuticals

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Lipoprotein Lipase Deficiency, Familial Hyperlipoproteinemia Type I Chylomicronemia, Familial Hypertriglyceridemia Drug: CAT-2003 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Phase 2 Pilot Study to Assess the Safety and Efficacy of CAT-2003 in Patients With Chylomicronemia
Study Start Date : March 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015


Arm Intervention/treatment
Experimental: CAT-2003 or Placebo
All patients will receive placebo for 1 week, and CAT-2003 for 12 weeks during the 13 week treatment period.
Drug: CAT-2003
Drug: Placebo



Primary Outcome Measures :
  1. Percent change from baseline in fasting triglycerides in patients with chylomicronemia [ Time Frame: 12 Weeks ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02098278


Locations
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Canada, Quebec
Chicoutimi, Quebec, Canada, G7H 7K9
Quebec City, Quebec, Canada, G1V 4M6
Sponsors and Collaborators
Catabasis Pharmaceuticals
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Responsible Party: Catabasis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02098278    
Other Study ID Numbers: CAT-2003-203
First Posted: March 28, 2014    Key Record Dates
Last Update Posted: July 21, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Hyperlipoproteinemia Type I
Hypertriglyceridemia
Hyperlipoproteinemias
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn