A Phase 2 Pilot Study to Assess the Safety and Efficacy of CAT-2003 in Patients With Severe Hypertriglyceridemia
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 16
- Primary Endpoint
- Percent change from baseline in fasting triglycerides in patients with severe hypertriglyceridemia
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 74 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
CAT-2003 or Placebo
All patients will receive placebo for a 14 day treatment period and CAT-2003 for a 28 day treatment period.
Intervention: CAT-2003 (Drug)
CAT-2003 or Placebo
All patients will receive placebo for a 14 day treatment period and CAT-2003 for a 28 day treatment period.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Percent change from baseline in fasting triglycerides in patients with severe hypertriglyceridemia
Time Frame: 4 weeks
Secondary Outcomes
- Frequency of adverse events(4 weeks)
- Absolute and percent change from baseline on postprandial total and chylomicron triglyceride levels(4 weeks)