Recruiting

Observational StudyAndrogens and NAFLD Longitudinal Cohort Study

Sponsor:

UCLA

Code:

NCT06124261

Conditions

PCOS

NAFLD

NASH

Eligibility Criteria

Sex: Female

Age: 18 - 42

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The researchers want to learn how androgens, a type of sex hormone, might affect nonalcoholic fatty liver (NAFLD) in young women over time. NAFLD happens when fat builds up in the liver which can cause damage to the liver such as inflammation or scarring.

Young women with a condition called polycystic ovary syndrome (PCOS) have a high risk for NAFLD, and they often have high androgen levels too. So the researchers are recruiting young women with PCOS as well as those without PCOS, and will compare changes in NAFLD over time between young women with and without PCOS.

This study is funded by the National Institutes of Health

Conditions

PCOS

NAFLD

NASH

Study ID

NCT06124261

Start date

Jan 22, 2024

Status verified date

Apr, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Sex: Female

Age: 18 - 42

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

MASLD and PCOS hyperandrogenism

Patients with MASLD and PCOS with the phenotype of hyperandrogenism

MASLD and PCOS non-hyperandrogenism

Patients with MASLD and PCOS with the phenotype of non-hyperandrogenism

MASLD and no-PCOS

Patients with metabolic dysfunction-associated steatotic liver disease (MASLD) and no PCOS

Primary outcome measure

Liver Stiffness Change [ Time Frame: from baseline to Year 3 follow- up. ]
Visceral Adipose Tissue (VAT) association to MASH severity [ Time Frame: at baseline ]

Central Contacts and Locations

Central contacts

Lily C Carbullido, B.S.

415-502-3725 myliverhealth@ucsf.edu

Locations

University of California San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Lily C Carbullido, B.S.

415-502-3725 myliverhealth@ucsf.edu

Jasmine Gamez, B.S.

415-353-9240 jasmine.gamez@ucsf.edu

More Information

Sponsor

University of California, San Francisco

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Keywords

Androgen

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-04-13.