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
1 other identifier
interventional
13
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2014
Shorter than P25 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 24, 2014
CompletedFirst Posted
Study publicly available on registry
March 28, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedJuly 21, 2016
July 1, 2016
1.1 years
March 24, 2014
July 19, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Percent change from baseline in fasting triglycerides in patients with chylomicronemia
12 Weeks
Secondary Outcomes (4)
Absolute and percent change from baseline on postprandial total and chylomicron triglyceride levels
12 Weeks
Absolute and percent change from baseline on chylomicron triglyceride clearance
12 Weeks
Absolute and percent change from baseline in plasma non-HDL-C
12 Weeks
Frequency of adverse events
13 weeks
Study Arms (1)
CAT-2003 or Placebo
EXPERIMENTALAll patients will receive placebo for 1 week, and CAT-2003 for 12 weeks during the 13 week treatment period.
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Unknown Facility
Chicoutimi, Quebec, G7H 7K9, Canada
Unknown Facility
Québec, Quebec, G1V 4M6, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2014
First Posted
March 28, 2014
Study Start
March 1, 2014
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
July 21, 2016
Record last verified: 2016-07