Nonalcoholic steatohepatitis (NASH), or fat-related liver inflammation and scarring is
projected to be the leading cause of cirrhosis in the United States (U.S.) within the next
few years. Women are at disproportionate risk for NASH, with approximately 15 million U.S.
women affected. There is an urgent need to understand risk factors for NASH and its
progression in women, and sex hormones may provide a missing link.
The investigator's preliminary data support a detrimental role of androgens, or "male sex
hormones" on fatty liver in women but no studies have evaluated whether androgens are
associated with liver inflammation and/or scarring from fatty liver (aka NASH). To better
understand the mechanism by which androgens might promote NASH and/or metabolic co-factors
that contribute to NASH, the investigators are conducting a pilot clinical trial to primarily
assess the feasibility of using an androgen blocking medication, spironolactone, in women
with NASH. Spironolactone was selected because it is has been commonly prescribed for decades
with good safety profile and tolerability to treat symptoms of high androgens, like acne and
hirsutism in young women. Though primarily a feasibility-focused study, the investigators
also aim to explore the pathways by which blocking testosterone receptors might alter the
biologic processes that promote NASH and its associated metabolic co-morbidities in women.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Monika Sarkar, MD University of California, San Francisco