Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia
Conditions
Brief summary
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.
Interventions
DRUGCAT-2003
DRUGPlacebo
DRUGStatin
All patients being treated with a stable dose of a statin prior to enrollment continue on their dosing regimen.
Sponsors
Catabasis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 4 weeks | 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. |
Countries
Canada, United States
Outcome results
None listed