NCT05979389 Bicalutamide Therapy in Young Women With NAFLD and PCOS
| NCT ID | NCT05979389 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University of California, San Francisco |
| Condition | NAFLD |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-02-14 |
| Primary Completion | 2028-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 50 participants in total. It began in 2024-02-14 with a primary completion date of 2028-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Monika A Sarkar, MD, MAS
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT05979389 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 42 Years, studying NAFLD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05979389 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05979389 currently recruiting?
Yes, NCT05979389 is actively recruiting participants. Contact the research team at myliverhealth@ucsf.edu for enrollment information.
Where is the NCT05979389 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT05979389 clinical trial?
NCT05979389 is sponsored by University of California, San Francisco. The principal investigator is Monika A Sarkar, MD, MAS at University of California, San Francisco. The trial plans to enroll 50 participants.