Pilot Study To Assess CAT-2003 in Patients With Hyperlipidemia

Study Overview
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Brief Summary
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The purpose of this study is to determine the safety and efficacy of different doses of CAT-2003 in patients with hyperlipidemia when CAT-2003 is taken for 4 weeks. The study will evaluate effects of CAT-2003 on (1) fasting triglycerides and non-HDL-C in patients with moderate hypertriglyceridemia and (2) fasting LDL-C levels in combination with a statin in patients with hypercholesterolemia who are on a statin.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled Pilot Study to Assess the Safety, Efficacy and Pharmacodynamics of CAT-2003 Alone and In Combination With A Statin in Patients With Hyperlipidemia (PATHWAYS I)

Conditions
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Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia

Intervention / Treatment
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* Drug: CAT-2003
* Drug: Placebo
* Drug: Statin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 18 and 69 years at Screening Hypertriglyceridemia (TG ≥ 200 mg/dL and < 500 mg/dL and non-HDL-C ≥ 100 mg/dL and < 220 mg/dL) OR Hypercholesterolemia (LDL-C ≥ 100 mg/dL and < 190 mg/dL and TG value < 200 mg/dL) plus a stable dose of statin 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 Any condition that may predispose the patient to secondary hyperlipidemia, such as uncontrolled hypothyroidism Any statin at the highest approved dose Non-statin lipid-altering drugs other than cholesterol absorption inhibitors. Active peptic ulcer disease or a history of muscle disease or myopathy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CAT-2003 or Placebo Dose 1<br>Daily for 28 days in patients with moderate hypertriglyceridemia | Drug: CAT-2003<br> <br> Drug: Placebo<br> <br> |
| Experimental: CAT-2003 or Placebo Dose 2<br>Daily for 28 days in patients with moderate hypertriglyceridemia | Drug: CAT-2003<br> <br> Drug: Placebo<br> <br> |
| Experimental: CAT-2003 or Placebo Dose 3<br>Daily for 28 days in patients with moderate hypertriglyceridemia | Drug: CAT-2003<br> <br> Drug: Placebo<br> <br> |
| Experimental: CAT-2003 or Placebo Dose 4<br>Daily for 28 days in patients with hypercholesterolemia who are on a statin | Drug: CAT-2003<br> <br> Drug: Placebo<br> <br> Drug: Statin<br>* All patients being treated with a stable dose of a statin prior to enrollment continue on their dosing regimen.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute and percent change from baseline in plasma triglycerides in patients with hypertriglyceridemia |  | 4 weeks | 
| Absolute and percent change from baseline in plasma low density lipoprotein-cholesterol in patients with hypercholesterolemia |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute and percent change from baseline in plasma non-high-density lipoprotein cholesterol |  | 4 weeks | 
| Pharmacodynamic effects of CAT-2003 on other lipid biomarkers in patients with hyperlipidemia |  | 4 weeks | 
| Frequency of adverse events | Safety and tolerability 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. | 4 weeks |