150 Participants NeededMy employer runs this trial

ALN-CIDEB for Non-Alcoholic Fatty Liver Disease

Recruiting at 15 trial locations
CT
Overseen ByClinical Trials Administrator
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Regeneron Pharmaceuticals
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 MASH.

In this study, researchers are looking at the effect of ALN-CIDEB on reducing liver fat, liver injury, and liver scarring. The study will compare ALN-CIDEB with placebo to understand how well ALN-CIDEB works to lower the amount of fat in the liver.

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 the body and the liver change after having ALN-CIDEB, 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 with a type of fatty liver disease called MASH, who have moderate to advanced liver scarring (fibrosis stage F2 or F3) and signs of active liver injury. Participants must show certain test results confirming their diagnosis.

Inclusion Criteria

I have been diagnosed with or am suspected to have MASH and metabolic syndrome risk factors.
My liver biopsy shows a NAFLD score of 4 or higher and moderate to advanced fibrosis.
3. Has a FibroScan Aspartate aminotransferase (FAST) score \>0.35 either at Screening Visit 1 or within approximately 3 months of Screening Visit 1 as described in the protocol
See 1 more

What Are the Treatments Tested in This Trial?

Interventions

  • ALN-CIDEB

Trial Overview

The study compares the new drug ALN-CIDEB to a placebo in people with MASH. Researchers want to see if ALN-CIDEB can reduce fat, injury, and scarring in the liver. Participants are randomly assigned to receive either ALN-CIDEB or placebo.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Placebo Group

Group I: ALN-CIDEB Dose 2Experimental Treatment1 Intervention
Group II: ALN-CIDEB Dose 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