Bicalutamide Therapy in Young Women With NAFLD and PCOS
Status:
Recruiting
Trial end date:
2028-08-01
Target enrollment:
Participant gender:
Summary
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. This study will study the
contribution of androgens to liver injury and progression in PCOS and mechanistic role of
dysregulated lipid metabolism and visceral adiposity in this process. Such findings will
provide the rationale for future efficacy studies evaluating selective androgen receptor (AR)
antagonism for NASH in PCOS, or alternatively, the need to directly target visceral adiposity
or lipid-specific pathways as part of a precision medicine approach to halt fibrosis
progression in the nearly 5 million young women with PCOS and NAFLD in the U.S., who remain
at increased risk for early onset and progressive liver disease.
Phase:
Phase 1
Details
Lead Sponsor:
University of California, San Francisco
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)