Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05979389 · ClinicalTrials.gov registry record · Phase 1
Bicalutamide Therapy in Young Women With NAFLD and PCOS
A Phase 1 study of NAFLD and PCOS, sponsored by University of California, San Francisco.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT05979389 is a Phase 1 study of NAFLD and PCOS that is actively recruiting participants, run by University of California, San Francisco. The registered enrollment target is 50 participants, below the 163-participant average among 26 other NAFLD trials with a reported enrollment target (69% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05979389, a Phase 1 study of NAFLD and PCOS, is actively recruiting participants, sponsored by University of California, San Francisco.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
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.
Interventions
- DRUG Placebo
- DRUG Bicalutamide 50 mg
Study Locations (1)
California
- University of California San Francisco - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2024-02-14 |
| Est. Completion | 2028-08 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05979389
The ClinicalTrials.gov registry entry for NCT05979389 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 163-participant average among 26 other NAFLD trials with a reported enrollment target (69% lower). The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with NAFLD appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05979389 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT05979389 about?
NCT05979389 is a clinical study titled "Bicalutamide Therapy in Young Women With NAFLD and PCOS". 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 urg...
What is the current status of trial NCT05979389?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2024-02-14. Estimated completion is 2028-08.
What conditions does trial NCT05979389 study?
This clinical trial studies the following conditions: NAFLD, PCOS.
What interventions are being tested in trial NCT05979389?
The interventions under investigation include: Placebo (DRUG), Bicalutamide 50 mg (DRUG).
Who is sponsoring clinical trial NCT05979389?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05979389 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for NAFLD
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
The Effects of Glucagon on Hepatic Metabolism
ACTIVE NOT RECRUITING · Phase 1
-
Safety Tolerability, and PK of RYI-018 After Repeat Dosing in Subjects With Non-Alcoholic Fatty Liver Disease (NAFLD)
COMPLETED · Phase 1
-
Pathogenesis of Pediatric Nonalcoholic Fatty Liver Disease (NAFLD)
RECRUITING
-
Randomized Double Blinded Placebo-Controlled w/Semaglutide to Prevent Weight Gain After Liver Transplant
RECRUITING · Phase 2
-
Reversal of Lipid-Induced Insulin Resistance
RECRUITING · NA
-
Digoxin In NASH (CODIN)
RECRUITING · Phase 2
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.