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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

Tracking Information
First Submitted Date  ICMJE March 24, 2014
First Posted Date  ICMJE March 28, 2014
Last Update Posted Date July 21, 2016
Study Start Date  ICMJE March 2014
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2014)
Percent change from baseline in fasting triglycerides in patients with chylomicronemia [ Time Frame: 12 Weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2014)
  • Absolute and percent change from baseline on postprandial total and chylomicron triglyceride levels [ Time Frame: 12 Weeks ]
  • Absolute and percent change from baseline on chylomicron triglyceride clearance [ Time Frame: 12 Weeks ]
  • Absolute and percent change from baseline in plasma non-HDL-C [ Time Frame: 12 Weeks ]
  • Frequency of adverse events [ Time Frame: 13 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot Study To Assess CAT-2003 in Patients With Chylomicronemia
Official Title  ICMJE A Phase 2 Pilot Study to Assess the Safety and Efficacy of CAT-2003 in Patients With Chylomicronemia
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Lipoprotein Lipase Deficiency, Familial
  • Hyperlipoproteinemia Type I
  • Chylomicronemia, Familial
  • Hypertriglyceridemia
Intervention  ICMJE
  • Drug: CAT-2003
  • Drug: Placebo
Study Arms  ICMJE 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.
Interventions:
  • Drug: CAT-2003
  • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 18, 2015)
13
Original Estimated Enrollment  ICMJE
 (submitted: March 27, 2014)
18
Actual Study Completion Date  ICMJE April 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02098278
Other Study ID Numbers  ICMJE CAT-2003-203
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Catabasis Pharmaceuticals
Study Sponsor  ICMJE Catabasis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Catabasis Pharmaceuticals
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP