Pilot Study To Assess CAT-2003 in Patients With Severe Hypertriglyceridemia
A Phase 2 Pilot Study to Assess the Safety and Efficacy of CAT-2003 in Patients With Severe Hypertriglyceridemia
1 other identifier
interventional
16
1 country
4
Brief Summary
The purpose of this study is to determine the safety and efficacy of multiple doses of CAT-2003 in patients with severe hypertriglyceridemia either naive or refractory to current therapy. The study will evaluate effects of CAT-2003 on fasting and postprandial total triglycerides and chylomicron triglyceride levels in patients with severe hypertriglyceridemia. This is a single-blind study. All patients will receive placebo for a 14 day treatment period and CAT-2003 for a 28 day 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 Oct 2013
Shorter than P25 for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 21, 2013
CompletedFirst Posted
Study publicly available on registry
October 24, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedAugust 14, 2015
July 1, 2015
6 months
October 21, 2013
July 27, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Percent change from baseline in fasting triglycerides in patients with severe hypertriglyceridemia
4 weeks
Secondary Outcomes (2)
Frequency of adverse events
4 weeks
Absolute and percent change from baseline on postprandial total and chylomicron triglyceride levels
4 weeks
Study Arms (1)
CAT-2003 or Placebo
EXPERIMENTALAll patients will receive placebo for a 14 day treatment period and CAT-2003 for a 28 day treatment period.
Interventions
Eligibility Criteria
You may qualify if:
- Between 18 and 74 years at Screening
- Severe Hypertriglyceridemia (TG ≥ 500 mg/dL). If on lipid lowering therapy including statins, fibrates, and/or omega-3 fatty acids, stable dose for at least 4 weeks prior to Screening
- Body mass index (BMI) ≤ 45 kg/m2
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Unknown Facility
Miami, Florida, 33143, United States
Unknown Facility
Indianapolis, Indiana, 46260, United States
Unknown Facility
Auburn, Maine, 04210, United States
Unknown Facility
Cincinnati, Ohio, 45227, United States
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
October 21, 2013
First Posted
October 24, 2013
Study Start
October 1, 2013
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
August 14, 2015
Record last verified: 2015-07