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Bicalutamide Therapy in Young Women With NAFLD and PCOS

NCT05979389 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-04-15

No results posted yet for this study

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.

Conditions

  • PCOS
  • NAFLD

Interventions

DRUG

Bicalutamide 50 mg

Bicalutamide capsules will be prepared from U.S. Pharmacopeia grade powder at a dose of 50 mg

DRUG

Placebo

Matching placebo capsules of the same color, mass, and appearance to the bicalutamide capsules will be filled using microcrystalline cellulose powder.

Sponsors & Collaborators

Principal Investigators

  • Monika A Sarkar, MD, MAS · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
42 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-14
Primary Completion
2028-08-31
Completion
2028-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05979389 on ClinicalTrials.gov