Dyslipidemias, Hyperlipidemias, Hypertriglyceridemia, Lipid Metabolism Disorders, Metabolic Diseases
Conditions
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.
Interventions
DRUGCAT-2003
DRUGPlacebo
Sponsors
Catabasis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change from baseline in fasting triglycerides in patients with severe hypertriglyceridemia | 4 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of adverse events | 4 weeks | 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 | 4 weeks | — |
Countries
United States
Outcome results
None listed