Phase 2 Non-Alcoholic Fatty Liver Disease Trial, Recruiting NCT05519475 Sponsor: Regeneron Pharmaceuticals Condition: Non-Alcoholic Fatty Liver Disease
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Phase 2 Non-Alcoholic Fatty Liver Disease Trial, Recruiting

NCT05519475
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 are 18 years of age or older (or the legal age of adulthood in their country)
  • People who have been diagnosed with a liver condition called MASH (a type of fatty liver disease) with a moderate level of liver scarring, classified as stage 2 or 3
  • People whose liver disease activity score (called a NAS score) is 3 or higher, as measured by a specific method set out in the trial rules
  • People who meet certain genetic criteria set out in the trial rules (confirm with trial site)
  • People who have had a specific liver assessment test called a FAST score (using a FibroScan® device combined with a blood test) either at the start of the trial or within about 12 weeks before joining

Who may not be able to join:

  • People who have another known long-term liver disease, beyond the condition being studied
  • People who have a known history of alcohol misuse or other substance misuse within the past year, or at any point during the screening period
  • People who have a history of Type 1 diabetes
  • People who have had weight-loss (bariatric) surgery within approximately the last 5 years, or who are planning to have it during the trial
  • People who have previously taken an experimental drug that targets specific proteins called HSD17B13 or PNPLA3 (for example, ALN-HSD, ARO-HSD, ALN-PNP, or AZD2693)

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 16 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
9 February 2023
Est. completion
27 April 2028

Where this trial is recruiting

🇯🇵 Japan Puerto Rico 🇰🇷 South Korea 🇺🇸 United States

Primary endpoints

Change in quantitative liver Fibrosis (qFibrosis)

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: 16 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