1500 Participants NeededMy employer runs this trial

ALN-CIDEB for Fatty Liver Disease

Recruiting at 3 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Regeneron Pharmaceuticals
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This study will test a Regeneron study drug called ALN-CIDEB to find out whether it may help treat a liver disease called metabolic dysfunction-associated steatohepatitis (MASH). MASH is more advanced stage of a broader liver disease, MASLD. MASLD is a liver condition caused by too much fat building up in the liver. This can lead to liver scarring and inflammation and can reduce the liver's ability to keep the body healthy. Cell death-inducing DFFA-like effector B (CIDEB) is a protein made by liver cells that helps the liver to store fat.

The study is looking at:

* What side effects ALN-CIDEB might cause

* How well ALN-CIDEB works to change liver fat, liver injury, and liver scarring

* How ALN-CIDEB could affect the body and the liver, which can help researchers understand why ALN-CIDEB works better for some people than others

Who Is on the Research Team?

CT

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with MASLD (a type of fatty liver disease) who have a certain level of liver stiffness measured by a special scan. People with other serious conditions or outside the specified liver stiffness range cannot join.

Inclusion Criteria

This is a key eligibility criterion for the study.
I have been diagnosed with MASLD by my doctor.
My liver stiffness is between 6 and 20 kPa on a recent FibroScan test.

What Are the Treatments Tested in This Trial?

Interventions

  • ALN-CIDEB

Trial Overview

The study compares ALN-CIDEB, an experimental drug, to a placebo in people with advanced fatty liver disease (MASH/MASLD). Participants are randomly assigned to receive either the drug or placebo to see if ALN-CIDEB improves liver health and reduces fat and scarring.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Placebo Group

Group I: ALN-CIDEB Dose Level 2Experimental Treatment1 Intervention
Group II: ALN-CIDEB Dose Level 1Experimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Regeneron Pharmaceuticals

Lead Sponsor

Trials
690
Recruited
948,000+
Founded
1988
Headquarters
Tarrytown, USA
Known For
Precision medicine
Top Products
Dupixent, EYLEA, Libtayo, Praluent
Leonard Schleifer profile image

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos profile image

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School