Recruiting
Phase 1

Bicalutamide with NAFLD

Sponsor:

UCLA

Code:

NCT05979389

Conditions

NAFLD

PCOS

Eligibility Criteria

Sex: Female

Age: 18 - 42

Healthy Volunteers: Not accepted

Interventions

Bicalutamide 50 mg

Placebo

Study Details

Brief 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

NAFLD

PCOS

Study ID

NCT05979389

Start date

Feb 14, 2024

Status verified date

May, 2026

Completion date

Aug, 2028

Anticipated

Primary completion date

Aug, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 42

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Women aged 18-42 years with hyperandrogenic PCOS
  • NASH identified on liver biopsy or probable NASH on transient elastography- controlled attenuation parameter (TE-CAP) with cutoffs defined as CAP score ≥270 decibel/m and TE score > 7.0 kPA or alanine aminotransferase ≥40 U/L).

Exclusion Criteria:

  • Uncontrolled diabetes
  • Alcohol consumption >2 drinks per day for at least 3 consecutive months over the previous 5 years
  • Other chronic liver disease (i.e. hepatitis B virus, hepatitis C virus, autoimmune hepatitis) or cirrhosis from any cause
  • Recent or planned upcoming weight reduction surgery within five years of diagnosis of biopsy-confirmed NASH
  • HIV infection
  • Drugs associated with fatty liver (i.e. amiodarone, methotrexate, systemic glucocorticoids, tamoxifen, anabolic steroids, valproic acid) for more than 4 weeks prior to baseline or during study
  • Recent, current, or planned upcoming pregnancy or current perimenopausal status
  • Renal impairment (glomerular filtration rate <45 ml/min/1.73m or potassium levels > 5.0 mmol/L)
  • Androgen receptor antagonist use (i.e. spironolactone or flutamide) for more than 3 months within one year prior to baseline

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Bicalutamide

50 mg capsule administered orally once daily for 6 months

placebo comparator: Placebo

Matching placebo capsule administered orally once daily for 6 months

Interventions

Bicalutamide 50 mg

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

Placebo

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

Primary outcome measure

  • Change in liver stiffness on Magnetic Resonance Elastography (MRE) [ Time Frame: Baseline and 6 months ]

Central Contacts and Locations

Central contacts

Lily Carbullido

(415)-502-3725myliverhealth@ucsf.edu

Locations

University of California San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Lily Carbullido

415-502-3725MyLiverHealth@ucsf.edu

Principal Investigator:

Monika Sarkar, M.D.

More Information

Sponsor

University of California, San Francisco

Last update posted

May 29, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-05-29.