A Phase 2 randomized, placebo controlled study assessing the efficacy, safety, and tolerability of MB07811 given orally to subjects with primary hypercholesterolemia for 12 weeks followed by a 6-week off drug phase.
This is an outpatient, Phase 2, multicenter, double-blind, placebo-controlled, randomized, parallel-group study assessing the efficacy, safety, and tolerability of MB07811 given orally to subjects with primary hypercholesterolemia for 12 weeks. There will be a 3- to 6-week screening/run-in period, including washout of any lipid-modifying therapies (as needed) prior to randomization. Eligible subjects will be randomized (1:1:1:1) to placebo, or 3 different doses of MB07811 for 12 weeks. After the double-blind treatment phase, all randomized subjects will proceed into a 6-week off-drug phase. Assessments include: laboratory tests, adverse events (AEs), electrocardiograms (ECGs), vitals, and PK samples.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
Scripps Clinic, Clinical Research
San Diego, California, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
University Clinical Research
Pembroke Pines, Florida, United States
Evaluate the effects of MB07811 compared to placebo on LDL-C
Time frame: 12-weeks of treatment
Evaluate the effects of MB07811 on other lipid markers compared to placebo
Time frame: 12 weeks
Assess the safety and tolerability of MB07811
Time frame: after 12 weeks of treatment and during off-drug phase
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