Hypercholesterolemia
Conditions
Brief summary
The purpose of this placebo-controlled, double-blind study is to assess the effect of several doses of CAT-2054 on LDL-C in hypercholesterolemic patients on a stable dose of high-intensity statin, and to evaluate the safety and tolerability of different doses of CAT-2054 for 4 weeks.
Interventions
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 74 Years
Healthy volunteers
No
Inclusion criteria
* Between 18 and 74 years at Screening * Hypercholesterolemia (LDL-C ≥ 70 mg/dL and \< 190 mg/dL) plus a stable dose of statin for at least 4 weeks prior to Screening * Satisfies one of the following: 1. Female patients of childbearing potential must have used appropriate and highly effective contraception (a regimen which results in a failure rate of \<1% per year) with their partners for 4 weeks prior to Screening, and remain compliant during the treatment phase and until 4 weeks after the last dose of investigational product 2. Male patients must use an acceptable and highly effective contraceptive method during the treatment phase and until 4 weeks after the last dose of investigational product * Body mass index (BMI) ≤45 kg/m2
Exclusion criteria
* History of any major cardiovascular event (stroke, TIA, MI, PTCI, CABG, hospitalization due to heart failure) within 6 months of Screening * Type I diabetes mellitus or use of insulin * Active peptic ulcer disease or a history of muscle disease or myopathy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in LDL-C from baseline in patients with hypercholesterolemia. | 4 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of adverse events | 8 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. |
| Percent change in TG, non-HDL-C, total cholesterol, HDL-C, apoB from baseline in patients with hypercholesterolemia | 4 weeks | — |
Countries
United States
Outcome results
None listed