Phase 2 Non-Alcoholic Fatty Liver Disease Trial, Recruiting NCT07527910 Sponsor: Regeneron Pharmaceuticals Condition: Non-Alcoholic Fatty Liver Disease
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Phase 2 Non-Alcoholic Fatty Liver Disease Trial, Recruiting

NCT07527910
Recruiting Phase 2

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:

  • People who carry two copies of a specific gene variant called PNPLA3 p.I148M (one inherited from each parent)
  • People whose liver contains 15% or more fat, as measured by a specific type of MRI scan called MRI-PDFF
  • People with a Body Mass Index (BMI) of 30 or above but below 45 (a measure of body weight relative to height)
  • For one part of the trial (Part A): People whose liver enzyme levels (ALT and AST) are within an acceptable range as set out in the trial protocol
  • For one part of the trial (Part A): People who are already taking a stable dose of the medication tirzepatide (at least 5 mg weekly) at the time of joining

Who may not be able to join:

  • People who have been diagnosed with, or show signs of, high blood pressure in the liver (portal hypertension) or severe liver scarring (cirrhosis), from any cause
  • People who have a known long-term liver condition other than a specific fat-related liver disease called MASLD
  • People for whom MRI scans are not safe or suitable — for example, those with certain types of pacemakers or metal implants in the body, severe fear of enclosed spaces, or body size that makes MRI scanning difficult
  • People for whom tirzepatide (Zepbound) is medically unsuitable, based on the official prescribing guidelines for that medication in the United States

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
Phase 2: approximately ~30% 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: Clinical Trial Management, Regeneron Pharmaceuticals

Phone: 844-734-6643

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 2
Sponsor
Regeneron Pharmaceuticals
Registry
ClinicalTrials.gov
Start date
22 May 2026
Est. completion
15 March 2030

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Percent change in liver fat; Percent change in 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: 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