Clinical trial Recruiting at 1 site Observational Ages 18 to 42 Women only

Investigating how androgens affect liver health in young women

Official title: Androgens and Nonalcoholic Fatty Liver Disease (NAFLD) In Reproductive-Aged Women With and Without Polycystic Ovary Syndrome (PCOS)

Run by University of California, San Francisco · NCT06124261 · Data updated 2026-11-12

This study is trying to see how hormones called androgens affect liver health in young women, especially those with polycystic ovary syndrome, by comparing liver disease progression between women with and without this condition.

More NAFLD trials

Quick facts

Study typeObservational
Ages18 Years to 42 Years
SexWomen only
Enrollment150 (estimated)
SponsorUniversity of California, San Francisco
Academic / other
Locations2 sites (San Francisco, California and 1 other locations)
StatusRecruiting
StartedJanuary 22, 2024
Main results expectedDecember 2028
Study endsDecember 2028
Registry record updatedApril 13, 2026
Trial IDNCT06124261 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include young women diagnosed with PCOS or those without PCOS who may be at risk for NAFLD.

Probably not a fit

Patients with high alcohol consumption, current pregnancy, or significant recent weight loss may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to explore the impact of androgens on nonalcoholic fatty liver disease (NAFLD) in young women, particularly focusing on those with polycystic ovary syndrome (PCOS). Researchers will compare the progression of NAFLD over time between young women with PCOS and those without. The study hypothesizes that androgens contribute to liver injury and the progression of NAFLD/NASH through mechanisms involving lipid metabolism and visceral fat activity. The research is funded by the National Institutes of Health and involves collaboration between the University of California, San Francisco, and Duke University.

Why it matters

Potential benefit: If successful, this study could lead to better understanding and management of liver health in young women with PCOS.

How similar studies have gone: While the specific approach of this study is novel, existing data suggest that androgens have significant effects on liver health in women, indicating potential for meaningful insights.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Metabolic associated steatohepatitis (MASH) (formerly NASH)
* PCOS
* Non-PCOS

Exclusion Criteria:

* High levels of alcohol use (more than 7 drinks a week)
* Current pregnancy
* Other causes of hepatic steatosis
* Weight loss of more than 10% body weight in the last 6 months

Where it's running

  • University of California San Francisco
    San Francisco, California, United States
    Recruiting
  • Duke University
    Durham, North Carolina, United States
    Not yet recruiting

Study contacts

  • Principal investigator: Monika A Sarkar, M.D., M.A.S — University of California, San Francisco
  • Study coordinator: Lily C Carbullido, B.S.
  • Email: myliverhealth@ucsf.edu
  • Phone: 415-502-3725

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.