A Study to Evaluate the Efficacy and Safety of ALN-HSD in Adult Participants With Non-alcoholic Steatohepatitis (NASH) With Fibrosis With Genetic Risk Factors

About the study

The study is researching an investigational drug called ALN-HSD (called "study drug" in this form). The study is focused on participants who are known to have non-alcoholic steatohepatitis (NASH). NASH is a form of non-alcoholic fatty liver disease (NAFLD). NASH occurs when fat builds up in liver cells, damaging them, and making the liver inflamed and stiff from fibrosis (scar tissue). NASH can progress to cirrhosis (long term scarring) and liver failure (when your liver cannot perform its job). The aim of the study is to see the effect of the study drug on lessening liver scarring side effects related to NASH. The study is looking at several other research questions, including: How ALN-HSD works to improve liver function and lessen NASH related inflammation in the liver What side effects may happen from receiving the study drug How much study drug and study drug metabolites (byproduct of the body breaking down the study drug) are in your blood at different times Better understanding of the study drug and NASH

Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Key Inclusion Criteria:

Adult male or female ≥18 years (or country's legal age of adulthood)
A diagnosis of NASH with fibrosis (F) stage 2 or 3
NAS score ≥4 according to the NASH CRN histological scoring system
Meets genotype criteria for study enrollment in either Study 1 or Study 2, as defined in the protocol
A Vibration-Controlled Transient Elastography (VCTE) liver stiffness measurement, as defined in the protocol

EXCLUSION CRITERIA

Key Exclusion Criteria:

Evidence of other forms of known chronic liver disease
Known history of alcohol or other substance abuse within the last year
History of Type 1 diabetes
Bariatric surgery within approximately 5 years prior to or planned during the study period
Prior exposure to any investigational drug targeting HSD17B13 or PNPLA3 (eg, ALNHSD or ARO-HSD, AZD2693)

Note: Other protocol-defined Inclusion/Exclusion Criteria apply

Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply

Contact the study center to learn if this study is a good match for you.

Study’s details

Contition

Nonalcoholic Steatohepatitis

Age (in years)

18 - 75

Phase

Phase 2

Participants needed

300

Est. Completion Date

Dec 9, 2026

Treatment type

Interventional

Sponsor

Regeneron Pharmaceuticals

ClinicalTrials.gov identifier

NCT05519475

Study number

ALN-HSD-NASH-2130

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