PCOSNCT06124261
Androgens and NAFLD Longitudinal Cohort Study
An observational study of PCOS and NAFLD, run by University of California, San Francisco at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Jan 2024to Dec 2028
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- No healthy volunteers
- Adult
Study population: Our study population includes pre-menopausal women ages 18-42 years, 125 with PCOS and 25 non-PCOS controls, with probable or confirmed metabolic associated steatohepatitis
Who may be able to join
- Metabolic associated steatohepatitis (MASH) (formerly NASH)
- PCOS
- Non-PCOS
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Jasmine Gamez contact
United States2 sites, 2 recruiting
- Not yet recruiting
Duke University
Durham, North Carolina, 27708
Linda Perry, R.N., linda.blalock@duke.edu
- Recruiting
University of California San Francisco
San Francisco, California, 94143
Lily C Carbullido, B.S., 415-502-3725, myliverhealth@ucsf.edu
Jasmine Gamez, B.S., 415-353-9240, jasmine.gamez@ucsf.edu
About this study
Official title: Androgens and Nonalcoholic Fatty Liver Disease (NAFLD) In Reproductive-Aged Women With and Without Polycystic Ovary Syndrome (PCOS)
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
Read the detailed description
The studies central hypothesis is that androgens promote liver injury and NAFLD/NASH progression in PCOS, which occurs through aberrant lipid activity (including lipotoxicity and dysregulated de novo lipogenesis), in part from androgenic effects on visceral adipose tissue (VAT). Data in young women taking exogenous testosterone show redistribution of fat from subcutaneous to visceral stores In the general population, VAT promotes NASH through several established pathways, including production of tissue injurious or "lipotoxic" lipids such as some phospholipid, sphingomyelin, and ceramide species. Recent data show androgen- associated increase in serum glycerophospholipids in women with PCOS, a lipid class that is associated with NASH in women. Additionally, androgen-associated de novo lipogenesis (DNL) may contribute to NASH in women. Hepatic DNL is a key source of lipid accumulation, and co-investigators at Duke University recently discovered an enzymatic balance that regulates hepatic DNL with dysregulation of this pathway (reflected by branched-chain keto and amino acids) predictive of prevalent NASH in humans. Androgen-induced de novo lipogenesis also occurs in cultured hepatocytes from women (but not men) supporting the researchers focused evaluation of the relationship between androgens, dysregulated hepatic DNL, and NASH in PCOS.
As existing data support androgenic effects on hepatic and visceral fat in women, the researchers will now determine the relationship of androgens with liver injury and progression in PCOS and the potential mechanistic contributions of VAT and aberrant lipid metabolism to this process. The team includes clinical and translational researchers at two centers (UCSF and Duke) with expertise in NAFLD, PCOS, obesity, and lipid metabolism, with a track record of collaboration. The study team will leverage an existing well-characterized PCOS cohort29 to follow 150 reproductive-aged women with NASH (125 PCOS and 25 non-PCOS controls) to accomplish this.
- Keywords
- Androgen
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver Stiffness Change
Mean change in liver stiffness (kPA) on magnetic resonance elastography (MRE)
Measured: from baseline to Year 3 follow- up.
Visceral Adipose Tissue (VAT) association to MASH severity
VAT volume (cm3) will be determined on magnetic resonance electrography (MRE)
Measured: at baseline
Secondary outcomes (1)
Liver stiffness severity
Severity of liver stiffness will be determined on magnetic resonance electrography (MRE)
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start22 Jan 2024
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PCOSStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
- Investigators
- Monika A Sarkar, M.D., M.A.S, Principal investigator, University of California, San FranciscoAmreen Dinani, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06124261
- Sponsor's protocol ID
- 23-39040
- Other IDs
- 1R01DK134633-01A1
- Status last verified
- Apr 2026
- First submitted
- 3 Nov 2023
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At present all data collected will be de-identified and shared with only the researchers apart of this study.
Publications
Sarkar M, Terrault N, Chan W, Cedars MI, Huddleston HG, Duwaerts CC, Balitzer D, Gill RM. Polycystic ovary syndrome (PCOS) is associated with NASH severity and advanced fibrosis. Liver Int. 2020 Feb;40(2):355-359. doi: 10.1111/liv.14279. Epub 2019 Nov 12.
PubMed 31627243Sarkar MA, Suzuki A, Abdelmalek MF, Yates KP, Wilson LA, Bass NM, Gill R, Cedars M, Terrault N; NASH Clinical Research Network. Testosterone is Associated With Nonalcoholic Steatohepatitis and Fibrosis in Premenopausal Women With NAFLD. Clin Gastroenterol Hepatol. 2021 Jun;19(6):1267-1274.e1. doi: 10.1016/j.cgh.2020.09.045. Epub 2020 Oct 1.
PubMed 33010412Sarkar M, Yates K, Suzuki A, Lavine J, Gill R, Ziegler T, Terrault N, Dhindsa S. Low Testosterone Is Associated With Nonalcoholic Steatohepatitis and Fibrosis Severity in Men. Clin Gastroenterol Hepatol. 2021 Feb;19(2):400-402.e2. doi: 10.1016/j.cgh.2019.11.053. Epub 2019 Dec 5.
PubMed 31812658Sarkar M, Terrault N, Duwaerts CC, Tien P, Cedars MI, Huddleston H. The Association of Hispanic Ethnicity with Nonalcoholic Fatty Liver Disease in Polycystic Ovary Syndrome. Curr Opin Gynecol Obstet. 2018 Feb 20;1(1):24-33. Epub 2018 Apr 5.
PubMed 30112518
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Androgens and Nonalcoholic Fatty Liver Disease (NAFLD) In Reproductive-Aged Women With and Without Polycystic Ovary Syndrome (PCOS)
- ClinicalTrials.gov ID
- NCT06124261
- Acronym / sponsor ID
- 23-39040
- Keywords
- Androgen
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Duke University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 9 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
The studies central hypothesis is that androgens promote liver injury and NAFLD/NASH progression in PCOS, which occurs through aberrant lipid activity (including lipotoxicity and dysregulated de novo lipogenesis), in part from androgenic effects on visceral adipose tissue (VAT). Data in young women taking exogenous testosterone show redistribution of fat from subcutaneous to visceral stores In the general population, VAT promotes NASH through several established pathways, including production of tissue injurious or "lipotoxic" lipids such as some phospholipid, sphingomyelin, and ceramide species. Recent data show androgen- associated increase in serum glycerophospholipids in women with PCOS, a lipid class that is associated with NASH in women. Additionally, androgen-associated de novo lipogenesis (DNL) may contribute to NASH in women. Hepatic DNL is a key source of lipid accumulation, and co-investigators at Duke University recently discovered an enzymatic balance that regulates hepatic DNL with dysregulation of this pathway (reflected by branched-chain keto and amino acids) predictive of prevalent NASH in humans. Androgen-induced de novo lipogenesis also occurs in cultured hepatocytes from women (but not men) supporting the researchers focused evaluation of the relationship between androgens, dysregulated hepatic DNL, and NASH in PCOS.
As existing data support androgenic effects on hepatic and visceral fat in women, the researchers will now determine the relationship of androgens with liver injury and progression in PCOS and the potential mechanistic contributions of VAT and aberrant lipid metabolism to this process. The team includes clinical and translational researchers at two centers (UCSF and Duke) with expertise in NAFLD, PCOS, obesity, and lipid metabolism, with a track record of collaboration. The study team will leverage an existing well-characterized PCOS cohort29 to follow 150 reproductive-aged women with NASH (125 PCOS and 25 non-PCOS controls) to accomplish this.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Our study population includes pre-menopausal women ages 18-42 years, 125 with PCOS and 25 non-PCOS controls, with probable or confirmed metabolic associated steatohepatitis
Key inclusion criteria (3 listed)
- Metabolic associated steatohepatitis (MASH) (formerly NASH)
- PCOS
- Non-PCOS
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Liver Stiffness Change
Time frame: from baseline to Year 3 follow- up.
Mean change in liver stiffness (kPA) on magnetic resonance elastography (MRE)
Visceral Adipose Tissue (VAT) association to MASH severity
Time frame: at baseline
VAT volume (cm3) will be determined on magnetic resonance electrography (MRE)
1 secondary outcome
Liver stiffness severity
Time frame: at baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Background: PubMed 31627243Sarkar M, Terrault N, Chan W, Cedars MI, Huddleston HG, Duwaerts CC, Balitzer D, Gill RM. Polycystic ovary syndrome (PCOS) is associated with NASH severity and advanced fibrosis. Liver Int. 2020 Feb;40(2):355-359. doi: 10.1111/liv.14279. Epub 2019 Nov 12.
- Background: PubMed 33010412Sarkar MA, Suzuki A, Abdelmalek MF, Yates KP, Wilson LA, Bass NM, Gill R, Cedars M, Terrault N; NASH Clinical Research Network. Testosterone is Associated With Nonalcoholic Steatohepatitis and Fibrosis in Premenopausal Women With NAFLD. Clin Gastroenterol Hepatol. 2021 Jun;19(6):1267-1274.e1. doi: 10.1016/j.cgh.2020.09.045. Epub 2020 Oct 1.
- Background: PubMed 31812658Sarkar M, Yates K, Suzuki A, Lavine J, Gill R, Ziegler T, Terrault N, Dhindsa S. Low Testosterone Is Associated With Nonalcoholic Steatohepatitis and Fibrosis Severity in Men. Clin Gastroenterol Hepatol. 2021 Feb;19(2):400-402.e2. doi: 10.1016/j.cgh.2019.11.053. Epub 2019 Dec 5.
- Background: PubMed 30112518Sarkar M, Terrault N, Duwaerts CC, Tien P, Cedars MI, Huddleston H. The Association of Hispanic Ethnicity with Nonalcoholic Fatty Liver Disease in Polycystic Ovary Syndrome. Curr Opin Gynecol Obstet. 2018 Feb 20;1(1):24-33. Epub 2018 Apr 5.
- Individual participant dataSharing planned: No. At present all data collected will be de-identified and shared with only the researchers apart of this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jasmine Gamez contact
Monika A Sarkar, M.D., M.A.S principal investigator
University of California, San Francisco
Amreen Dinani, MD principal investigator
Duke University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PCOS and NAFLD, run by University of California, San Francisco at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lily C Carbullido, B.S. (415-502-3725, myliverhealth@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver Stiffness Change (time frame: from baseline to Year 3 follow- up.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06124261, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.