A study looking at the effect of pioglitazone in skeletal muscle of patients with sporadic inclusion body myositis (sIBM).
This is a 52-week, Phase 1, open-label, single center, proof of concept study of FDA-approved pioglitazone in adult patients with sporadic inclusion body myositis (sIBM). The trial consists of a 4-week screening period;16-week "lead-in" period during which all subjects are observed off-treatment. At Week 16, all subjects will be started on pioglitazone at a dose of 30 mg daily. The dose will be uptitrated to a goal dose of 45 mg daily after 2 weeks; 32-week treatment period with all subjects on 45 mg daily dose of pioglitazone.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
19
Pioglitazone comes as a tablet to take by mouth and can be taken with or without food.
Johns Hopkins University
Baltimore, Maryland, United States
Change from baseline in Peroxisome proliferator-activated receptor gamma coactivator 1-alpha target gene expression
Effect of 45 milligram pioglitazone dose on the expression of Peroxisome proliferator-activated receptor gamma coactivator 1-alpha target genes
Time frame: 4 weeks, 16 weeks, 32 weeks after baseline
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