Non-Alcoholic Fatty Liver Disease Trial, Recruiting NCT06138821 Sponsor: Pichamol Jirapinyo, MD, MPH Condition: Non-Alcoholic Fatty Liver Disease
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Non-Alcoholic Fatty Liver Disease Trial, Recruiting

NCT06138821
Recruiting Not Applicable

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:

  • You are 18 years of age or older (any gender)
  • Your body mass index (BMI) is 30 or above, OR your BMI is 27 or above and you have at least one health condition related to your weight (such as high blood pressure or type 2 diabetes)
  • Your weight has been stable (no more than 5% change) for the 6 months before your first visit
  • You are willing to follow all study requirements, including signing a consent form, attending follow-up visits, completing tests, and participating in diet counseling
  • You are willing to not start any new weight-loss medications for the next 12 months
  • You live close enough to the trial site to attend regular follow-up visits
  • You are able to understand and sign a consent form agreeing to take part
  • If you are a woman who could become pregnant, you must agree to use a reliable form of birth control during the trial

Who may not be able to join:

  • You have a known history of other long-term liver diseases, such as viral hepatitis, autoimmune hepatitis, drug-related hepatitis, or inherited liver conditions
  • You have taken certain medications (vitamin E at high doses, pioglitazone, obeticholic acid, or resmetirom) in the 90 days before your first visit
  • You have had previous surgery on your stomach or digestive tract (except for certain simple procedures like gallbladder removal or appendix removal)
  • You have had weight-loss (bariatric) surgery in the past
  • You have had a previous endoscopic sleeve gastroplasty (a non-surgical stomach-reducing procedure)
  • You have any inflammatory condition of the digestive tract, such as severe acid damage to the esophagus, Barrett's esophagus with abnormal cells, stomach or small intestine ulcers, cancer, or Crohn's disease
  • You have conditions that could cause serious bleeding in your upper digestive tract, such as enlarged veins in the esophagus or stomach, or certain abnormal blood vessel growths
  • You have severe acid reflux (GERD)
  • You have a structural problem in your esophagus or throat (such as a narrowing or pouch) that could make it difficult to pass a medical scope through
  • You have achalasia or another serious condition affecting how your esophagus moves food
  • You experience chronic (ongoing) abdominal pain
  • You have gastroparesis (slow stomach emptying) or very persistent constipation
  • You have significant liver failure or cirrhosis (severe liver scarring)
  • You have a serious blood clotting disorder
  • You have insulin-dependent diabetes (type 1 or type 2), are likely to need insulin in the next 12 months, or have very poorly controlled blood sugar (HbA1c of 12% or higher)
  • You regularly take blood-thinning medications, anti-platelet drugs, or anti-inflammatory painkillers (NSAIDs)
  • You regularly take steroids, immunosuppressants, or strong prescription pain medications (narcotics)
  • You take anti-seizure or heart rhythm medications
  • You are currently pregnant or breastfeeding
  • You drink more than a moderate amount of alcohol (more than 20g per day for women or 30g per day for men) (confirm with trial site for exact amounts)
  • You are currently an active smoker
  • You have a history of poorly controlled high blood pressure, coronary artery disease, heart failure, or irregular heart rhythm
  • You have a history of certain serious breathing conditions such as COPD requiring steroid treatment, pneumonia, or lung cancer
  • You have a history of autoimmune conditions such as lupus or scleroderma, or a weakened immune system
  • You currently have an active cancer
  • Your obesity is caused by a genetic or hormonal condition, such as Prader-Willi syndrome
  • You have an uncontrolled hormonal disorder affecting your weight, such as uncontrolled underactive thyroid
  • You have an eating disorder, such as bulimia, binge eating disorder, night eating syndrome, or compulsive overeating
  • You have active mental health conditions that, as assessed by a psychologist, would prevent you from taking part in a lifestyle change program

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 28 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Pichamol Jirapinyo, MD, MPH, Brigham and Women's Hospital

Phone: 617-732-5174

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
Not Applicable
Sponsor
Pichamol Jirapinyo, MD, MPH
Registry
ClinicalTrials.gov
Start date
24 June 2025
Est. completion
1 December 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

MASH resolution without worsening of liver fibrosis at 12 months

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: 28 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