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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: Recruiting Phase 1 study of NAFLD and PCOS, sponsored by University of California, San Francisco.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The investigators will assess for change in the MRE quantified liver stiffness in kilopascals (kPA)
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 |
What NCT05979389 shows while recruiting
NCT05979389 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 163-participant average among 26 other NAFLD trials with a reported enrollment target (69% lower).
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 a single indexed study location in 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.
Where NCT05979389's enrollment target sits among peer trials
50 19th of 26 higher than 6 of 26 other NAFLD trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NAFLD trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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