- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02098278
Pilot Study To Assess CAT-2003 in Patients With Chylomicronemia
A Phase 2 Pilot Study to Assess the Safety and Efficacy of 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Quebec
-
Chicoutimi, Quebec, Canada, G7H 7K9
-
Quebec City, Quebec, Canada, G1V 4M6
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percent change from baseline in fasting triglycerides in patients with chylomicronemia
Time Frame: 12 Weeks
|
12 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Absolute and percent change from baseline on postprandial total and chylomicron triglyceride levels
Time Frame: 12 Weeks
|
12 Weeks
|
Absolute and percent change from baseline on chylomicron triglyceride clearance
Time Frame: 12 Weeks
|
12 Weeks
|
Absolute and percent change from baseline in plasma non-HDL-C
Time Frame: 12 Weeks
|
12 Weeks
|
Frequency of adverse events
Time Frame: 13 weeks
|
13 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAT-2003-203
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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