A Phase 1 interventional study of Bicalutamide 50 mg and Placebo in NAFLD and PCOS, sponsored by University of California, San Francisco. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 42 Years. Per ClinicalTrials.gov, last updated 2026-05-29.
Sponsored by University of California, San Francisco · Phase 1, Interventional, and Other
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.
This is a single center, double-blind, placebo-controlled, randomized, (1:1) parallel group pilot clinical trial of bicalutamide in women with either biopsy-proven or believed NAFLD receiving 6 months of bicalutamide or placebo. 50 women are targeted for enrollment. Each participant will be administered a single dose of bicalutamide or placebo once daily for a total of 6 months. In person evaluations will take place at Month 1, 2, 3, 4, 5, and 6. There will be a telephone follow up visit within 1 month of end of treatment. This is a pilot clinical trial that is largely feasibility focused. Study outcomes will include:
1,474 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 303 are open to participants now.
This study's planned enrollment of 50 is below the median of 60 across 1,072 interventional studies indexed under Non-alcoholic Fatty Liver Disease.
Browse Non-alcoholic Fatty Liver Disease studies →University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
50 mg capsule administered orally once daily for 6 months
Drug: Bicalutamide 50 mg
Matching placebo capsule administered orally once daily for 6 months
Drug: Placebo
Bicalutamide capsules will be prepared from U.S. Pharmacopeia grade powder at a dose of 50 mg
Also known as: Casodex
Matching placebo capsules of the same color, mass, and appearance to the bicalutamide capsules will be filled using microcrystalline cellulose powder.
Change in liver stiffness on Magnetic Resonance Elastography (MRE)
The investigators will assess for change in the MRE quantified liver stiffness in kilopascals (kPA)
Time frame: Baseline and 6 months
Change in hepatic steatosis by Magnetic Resonance Proton Density Fat Fraction (PDFF)
The investigators will assess for percent change in fat fraction by MRI-PDFF
Time frame: Baseline and 6 months
Change in visceral adipose tissue (VAT) volume by Magnetic Resonance Imaging (MRI)
The investigators will assess for percent change in VAT as quantified by MRI
Time frame: Baseline and 6 months
Change HOMA-IR (Homeostatic model assessment (HOMA) for insulin resistance (IR))
The investigators will assess change in continuous measures of HOMA-IR as insulin resistance is known to contribute to NASH progression
Time frame: Baseline and 6 months
Change in the NAFLD Activity Score (NAS) on a scale from 0 (low activity) to 8 (high activity)
The investigators will assess for change in this histologic scoring system of NASH as a continuous measure among women willing to undergo end of treatment biopsy (not required).
Time frame: Baseline and 6 months
Plan to share: No
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Non-alcoholic Fatty Liver Disease→
University of California, San Francisco