What side effects are associated with this type of intervention?

Common treatments for Non-alcoholic Fatty Liver Disease (NAFLD) include lifestyle modifications, medications like pioglitazone, vitamin E, and emerging therapies such as selective androgen receptor antagonists. Pioglitazone can cause weight gain, edema, and an increased risk of bone fractures. Vitamin E is generally well-tolerated but can increase the risk of hemorrhagic stroke. Selective androgen receptor antagonists, which are being studied for their role in reducing liver injury and progression in conditions like PCOS, may have side effects such as gynecomastia, decreased libido, and fatigue. These treatments aim to address underlying metabolic issues and reduce liver inflammation and fibrosis.

What prior FDA approvals exist?

Currently, there are no FDA-approved treatments specifically for Non-alcoholic Fatty Liver Disease (NAFLD). However, several drugs have shown efficacy in managing the condition, including lipid-lowering agents like atorvastatin, and other treatments such as tryptophan, orlistat, omega-3 fatty acids, and obeticholic acid. These treatments focus on reducing liver enzymes, body mass index (BMI), and liver steatosis. While selective androgen receptor antagonism is being studied for its potential to reduce liver injury and progression in NAFLD, it has not yet received FDA approval.

What other types of research exist?

Promising alternatives to Selective Androgen Receptor Antagonism for NAFLD treatment include: 1) Selective thyroid hormone receptor β (THR-β) agonists, which target dyslipidemia and NAFLD; 2) Selective peroxisome proliferator-activated receptor-delta (PPAR-δ) agonists like seladelpar, which improve atherogenic dyslipidemia and reverse hepatic lipotoxicity; and 3) GPR119 ligands, which regulate energy metabolism and may be beneficial for metabolic diseases including NAFLD.

← Back to Search

Hormone Therapy

Bicalutamide for NAFLD and PCOS

Phase 1

Recruiting

Led By Monika A Sarkar, MD, MAS

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 6 months

Summary

This trial tests bicalutamide, a medication that blocks certain hormones, in women with NAFLD and PCOS. The goal is to see if it can reduce liver damage by stopping harmful hormone effects.

Who is the study for?

This trial is for young women aged 18-40 with PCOS and NAFLD, diagnosed through liver biopsy or specific tests. Participants should not have used certain drugs that affect the liver, have uncontrolled diabetes, severe kidney issues, a history of excessive alcohol use, other chronic liver diseases or be pregnant.

What is being tested?

The study is testing Bicalutamide's effectiveness in treating fat-related liver inflammation in women with PCOS. It compares Bicalutamide (50 mg) against a placebo to see if it can improve NASH by targeting androgen receptors.

What are the potential side effects?

While the side effects are not detailed here, Bicalutamide commonly includes breast tenderness or enlargement, hot flashes, itching skin or rash and gastrointestinal discomfort.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in liver stiffness on Magnetic Resonance Elastography (MRE)

Secondary study objectives

Change HOMA-IR (Homeostatic model assessment (HOMA) for insulin resistance (IR))

Change in hepatic steatosis by Magnetic Resonance Proton Density Fat Fraction (PDFF)

Change in the NAFLD Activity Score (NAS) on a scale from 0 (low activity) to 8 (high activity)

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: BicalutamideExperimental Treatment1 Intervention

50 mg capsule administered orally once daily for 6 months

Group II: PlaceboPlacebo Group1 Intervention

Matching placebo capsule administered orally once daily for 6 months

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Selective androgen receptor antagonists inhibit androgen receptor activity, reducing liver injury and progression in Non-alcoholic Fatty Liver Disease (NAFLD) patients, especially those with conditions like Polycystic Ovary Syndrome (PCOS) where elevated androgens contribute to liver damage. Other common treatments for NAFLD include lifestyle modifications, insulin-sensitizing agents like metformin, and lipid-lowering agents such as statins. These treatments aim to reduce liver fat, improve insulin sensitivity, and decrease inflammation, thereby slowing the progression of liver disease.