Phase 1 Non-Alcoholic Fatty Liver Disease Trial, Recruiting NCT05979389 Sponsor: University of California, San Francisco Condition: Non-Alcoholic Fatty Liver Disease
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Phase 1 Non-Alcoholic Fatty Liver Disease Trial, Recruiting

NCT05979389
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Women between the ages of 18 and 42 who have been diagnosed with a hormone condition called PCOS that involves higher-than-normal levels of male hormones (androgens)
  • Women who have a specific type of liver disease called NASH (a form of fatty liver disease with inflammation), confirmed either by a liver biopsy or by a specialist scan and/or elevated liver enzyme levels in the blood

Who may not be able to join:

  • People whose diabetes is not well controlled
  • People who have drunk more than 2 alcoholic drinks per day for at least 3 months in a row at any point in the last 5 years
  • People who have another ongoing liver condition (such as hepatitis B, hepatitis C, or autoimmune hepatitis) or severe liver scarring (cirrhosis) from any cause
  • People who have had, or are planning to have, weight-loss surgery within five years of being diagnosed with NASH confirmed by liver biopsy
  • People who are living with HIV
  • People who have taken certain medications known to cause fatty liver (such as amiodarone, methotrexate, steroids, tamoxifen, anabolic steroids, or valproic acid) for more than 4 weeks before or during the study
  • People who are recently pregnant, currently pregnant, planning to become pregnant, or going through perimenopause
  • People with reduced kidney function or high potassium levels in the blood (confirm with trial site)
  • People who have taken certain hormone-blocking medications (such as spironolactone or flutamide) for more than 3 months within the year before joining the study

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Monika A Sarkar, MD, MAS, University of California, San Francisco

Phone: (415)-502-3725

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Registry
ClinicalTrials.gov
Start date
14 February 2024
Est. completion
1 August 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in liver stiffness on Magnetic Resonance Elastography (MRE)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov