Homozygous Familial Hypercholesterolemia Clinical Trial
Official title:
A 12-week, Open-label, Dose-escalating, Phase 2 Study to Evaluate the Effects of MBX-8025 in Patients With Homozygous Familial Hypercholesterolemia (HoFH)
A 12-week, open-label, dose-escalating, phase 2 study to evaluate the effects of MBX-8025 in patients with Homozygous Familial Hypercholesterolemia (HoFH).
Open-label, single arm, non-controlled, dose ascending (50 mg/day, 100 mg/day and 200
mg/day) with three consecutive dose escalation periods.
After signing an informed consent subject will enter a screening period and a run-in
stabilization period. At the end of run-in period patients will enter treatment phase.
MBX-8025 in ascending doses (50 mg, 100 mg, and 200 mg) will be given within three
consecutive 4 weeks periods, for a total of 12 weeks. At the end of treatment, subjects will
enter a follow-up period.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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