A Phase 3, Randomized, Double-blind, Placebo-controlled Trial of ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

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

Start Date06 Nov 2026

Sponsor / Collaborator

Regeneron Pharmaceuticals, Inc.

NCT07631637

/ Not yet recruitingPhase 2

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study of ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)

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

Start Date15 Jul 2026

Sponsor / Collaborator

Regeneron Pharmaceuticals, Inc.

NCT06836609

/ RecruitingPhase 1/2

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Two-Part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of ALN-CIDEB in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) and Two Doses of ALN-CIDEB in Adult Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH)

This study is researching an experimental drug called ALN-CIDEB, also referred to as "study drug". The study is focused on participants with metabolic dysfunction-associated steatotic liver disease (MASLD) (Part A) and metabolic dysfunction-associated steatohepatitis (MASH) (Part B). MASLD and MASH are long-lasting liver conditions caused by having too much fat in the liver.
The aim of the study is to see how safe and tolerable the study drug is.
The study is looking at several other research questions, including:
* What side effects may happen from taking the study drug
* How the study drug works to change liver fat content
* How much study drug and study drug metabolites (byproducts of the body breaking down the study drug) are in the blood at different times

Start Date28 Apr 2025

Sponsor / Collaborator

Regeneron Pharmaceuticals, Inc.

100 Clinical Results associated with ALN-CIDEB

100 Translational Medicine associated with ALN-CIDEB

100 Patents (Medical) associated with ALN-CIDEB

100 Deals associated with ALN-CIDEB

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Metabolic dysfunction-associated steatotic liver disease	Phase 3	-	Regeneron Pharmaceuticals, Inc.	06 Nov 2026
Metabolic Dysfunction Associated Steatohepatitis	Phase 2	United States	Regeneron Pharmaceuticals, Inc.	28 Apr 2025
Metabolic Dysfunction Associated Steatohepatitis	Phase 2	United States	Alnylam Pharmaceuticals, Inc.	28 Apr 2025
Metabolic Dysfunction Associated Steatohepatitis	Phase 2	United Kingdom	Regeneron Pharmaceuticals, Inc.	28 Apr 2025

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