Pilot Study To Assess CAT-2003 in Patients With Severe Hypertriglyceridemia
Primary Purpose
Hyperlipidemias, Hypertriglyceridemia, Dyslipidemias
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CAT-2003
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hyperlipidemias
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- History of any major cardiovascular event within 6 months of Screening
- Type I diabetes mellitus or use of insulin
- History of pancreatitis
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CAT-2003 or Placebo
Arm Description
All patients will receive placebo for a 14 day treatment period and CAT-2003 for a 28 day treatment period.
Outcomes
Primary Outcome Measures
Percent change from baseline in fasting triglycerides in patients with severe hypertriglyceridemia
Secondary Outcome Measures
Frequency of adverse events
Safety will be assessed for all enrolled patients from the time the patient signs the informed consent through post-treatment follow-up.
Safety parameters include physical exam, vital signs, clinical laboratory tests, ECGs and concomitant medications.
Absolute and percent change from baseline on postprandial total and chylomicron triglyceride levels
Full Information
NCT ID
NCT01968720
First Posted
October 21, 2013
Last Updated
July 27, 2015
Sponsor
Catabasis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01968720
Brief Title
Pilot Study To Assess CAT-2003 in Patients With Severe Hypertriglyceridemia
Official Title
A Phase 2 Pilot Study to Assess the Safety and Efficacy of CAT-2003 in Patients With Severe Hypertriglyceridemia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Catabasis Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemias, Hypertriglyceridemia, Dyslipidemias, Lipid Metabolism Disorders, Metabolic Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CAT-2003 or Placebo
Arm Type
Experimental
Arm Description
All patients will receive placebo for a 14 day treatment period and CAT-2003 for a 28 day treatment period.
Intervention Type
Drug
Intervention Name(s)
CAT-2003
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Percent change from baseline in fasting triglycerides in patients with severe hypertriglyceridemia
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Frequency of adverse events
Description
Safety will be assessed for all enrolled patients from the time the patient signs the informed consent through post-treatment follow-up.
Safety parameters include physical exam, vital signs, clinical laboratory tests, ECGs and concomitant medications.
Time Frame
4 weeks
Title
Absolute and percent change from baseline on postprandial total and chylomicron triglyceride levels
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
History of any major cardiovascular event within 6 months of Screening
Type I diabetes mellitus or use of insulin
History of pancreatitis
Facility Information:
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
City
Auburn
State/Province
Maine
ZIP/Postal Code
04210
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pilot Study To Assess CAT-2003 in Patients With Severe Hypertriglyceridemia
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