Phase 3 Non-Alcoholic Fatty Liver Disease Trial, Recruiting NCT04833140 Sponsor: Massachusetts General Hospital Condition: Non-Alcoholic Fatty Liver Disease
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Phase 3 Non-Alcoholic Fatty Liver Disease Trial, Recruiting

NCT04833140
Recruiting Phase 3

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 who have gone through menopause and are between 45 and 70 years old
  • People who have been diagnosed with a specific type of liver disease called NASH (confirmed by a liver tissue sample) or a related condition called NAFLD (confirmed by a medical scan) within the past 6 months
  • People whose blood tests show no signs of Hepatitis B or Hepatitis C infection
  • People who have had a clear mammogram (breast screening) within the past year

Who may not be able to join:

  • People who drink alcohol heavily
  • People who have used medications specifically to treat NASH in the past 12 months
  • People who have been diagnosed with cirrhosis (severe liver scarring), have advanced scarring shown on a liver tissue sample, or show signs of serious liver damage on scans or physical examination
  • People who have taken part in another NASH clinical trial within the past 6 months
  • People who have regularly used certain medications — including corticosteroids (steroid medicines), methotrexate, amiodarone, or tamoxifen — within the past 6 months
  • People who have a known liver disease other than NAFLD, or where a liver tissue sample shows a different liver condition
  • People for whom a liver biopsy (tissue sample procedure) would not be safe — for example, due to certain blood clotting results, low platelet counts, fluid in the abdomen, ongoing blood-thinning medication (other than aspirin), bile duct blockage, abdominal infection, or inability to lie flat for 30 minutes (confirm with trial site)
  • People with low haemoglobin (a measure of red blood cells) or reduced kidney function below certain levels (confirm with trial site)
  • People for whom oestrogen therapy is medically unsuitable
  • People who have had any vaginal bleeding or spotting within the past year
  • People with an active cancer diagnosis
  • People with a severe ongoing illness
  • People who have used oestrogen or progesterone (hormone treatments) within the past year
  • People who cannot have an MRI scan — for example, those with a pacemaker or a surgical clip for a brain aneurysm

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 27 July 2026
Phase 3: approximately ~65% 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: Karen K. Miller, MD, Massachsuetts General Hospital

Phone: 617-643-8635

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 3
Registry
ClinicalTrials.gov
Start date
2 December 2021
Est. completion
31 May 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Liver fat

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: 27 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