Phase 2 Non-Alcoholic Fatty Liver Disease Trial, Recruiting NCT05648214 Sponsor: Regeneron Pharmaceuticals Condition: Non-Alcoholic Fatty Liver Disease
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Phase 2 Non-Alcoholic Fatty Liver Disease Trial, Recruiting

NCT05648214
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:

For healthy adults (Part A):

  • You are between 18 and 55 years old
  • You have a body mass index (BMI) — a measure of body weight relative to height — between 18 and 32
  • A doctor has reviewed you and considers you to be in good health
  • Your recent blood test results are within a healthy range

For Japanese participants in the healthy adult group only:

  • You were born in Japan, both of your biological parents and all four biological grandparents are ethnically Japanese and were born in Japan
  • You have maintained a Japanese lifestyle and diet since leaving Japan
  • You have been living outside of Japan for fewer than 10 years

For adults with a specific liver condition called MASLD (Parts B and C):

  • You are between 18 and 65 years old (Part B) or 18 and 75 years old (Part C)
  • If you are of East Asian background (e.g. Chinese, Japanese, South Korean, Taiwanese), your BMI is between 23 and 40; for all other backgrounds, your BMI is between 27 and 40
  • A special type of liver scan (MRI) shows that at least 8.5% of your liver is made up of fat

Who may not be able to join:

For healthy adults (Part A):

  • You have a significant history of heart, lung, liver, kidney, digestive, hormonal, blood, mental health, nerve, or skin conditions that could affect the study
  • You have been in hospital for any reason within the past 30 days
  • Your kidney filtering function falls below a certain level (confirm with trial site)
  • Your blood test results show that certain liver-related values — ALT, AST, or bilirubin — are above the normal range
  • You currently smoke or use e-cigarettes, or you stopped smoking within the last 3 months
  • You have a history of alcohol or drug misuse, in the opinion of the study doctor
  • You have tested positive for Hepatitis C antibodies and also have an active Hepatitis C virus infection

For adults with MASLD (Parts B and C):

  • You have another known long-term liver disease
  • You are unable to have an MRI scan for any reason (e.g. a pacemaker or metal implants — confirm with trial site)
  • You have a history of Type 1 diabetes
  • Your body weight has changed by more than 4% (either gained or lost) in the 3 months before or during the screening period
  • You have HIV, an active or ongoing Hepatitis B infection, or an active or ongoing Hepatitis C infection
  • You have had weight-loss (bariatric) surgery within the past 5 years (Part B) or 3 years (Part C), or you are planning to have it during 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 8 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
27 December 2022
Est. completion
10 August 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Incidence of Treatment-Emergent Adverse Events (TEAEs); Severity of TEAEs

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: 8 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