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RECRUITINGPhase 2INTERVENTIONAL

A Precision Medicine Approach Using Gene Silencing to Treat a Chronic Liver Disease Called Metabolic Dysfunction-Associated Steatohepatitis (MASH) in Adult Participants at Increased Genetic Risk for This Condition

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of siRNA Gene Silencing for the Treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH) in Participants With Genetic Risk Factors

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This study is researching an investigational drug, ALN-HSD called "study drug". This study is focused on participants who are known to have metabolic dysfunction-associated steatohepatitis (MASH). MASH is a form of metabolic dysfunction-associated steatotic liver disease (MASLD). MASH occurs when fat builds up in liver cells, damaging them, and making the liver inflamed and stiff from fibrosis (scar tissue). MASH can progress to cirrhosis (long term scarring) and liver failure (when the 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 MASH. The study is looking at several other research questions, including: * How ALN-HSD works to improve liver function and lessen MASH-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 the blood at different times * Better understanding of the study drug and MASH

Who May Be Eligible (Plain English)

Key Who May Qualify: 1. Adult male or female ≥18 years (or country's legal age of adulthood) 2. A diagnosis of MASH with fibrosis (F) stage 2 or 3, according to the NASH-Clinical Research Network (CRN) 3. NAS score ≥3, as defined in the protocol 4. Meets genotype criteria for study enrollment, as defined in the protocol 5. Has protocol defined FibroScan®-AST (FAST) score at screening or within approximately 12 weeks of screening Key Who Should NOT Join This Trial: 1. Evidence of other forms of known chronic liver disease, as defined in the protocol 2. Known history of alcohol or other substance abuse within the last year or at any time during screening, as defined in the protocol 3. History of Type 1 diabetes 4. Bariatric surgery within approximately 5 years prior to or planned during the study period 5. Prior exposure to any investigational drug targeting HSD17B13 or patatin-like phospholipase domain containing 3 (PNPLA3) (eg, ALN-HSD, ARO-HSD, ALN-PNP, AZD2693) Note: Other protocol-defined Inclusion/Exclusion Criteria apply Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Key Inclusion Criteria: 1. Adult male or female ≥18 years (or country's legal age of adulthood) 2. A diagnosis of MASH with fibrosis (F) stage 2 or 3, according to the NASH-Clinical Research Network (CRN) 3. NAS score ≥3, as defined in the protocol 4. Meets genotype criteria for study enrollment, as defined in the protocol 5. Has protocol defined FibroScan®-AST (FAST) score at screening or within approximately 12 weeks of screening Key Exclusion Criteria: 1. Evidence of other forms of known chronic liver disease, as defined in the protocol 2. Known history of alcohol or other substance abuse within the last year or at any time during screening, as defined in the protocol 3. History of Type 1 diabetes 4. Bariatric surgery within approximately 5 years prior to or planned during the study period 5. Prior exposure to any investigational drug targeting HSD17B13 or patatin-like phospholipase domain containing 3 (PNPLA3) (eg, ALN-HSD, ARO-HSD, ALN-PNP, AZD2693) Note: Other protocol-defined Inclusion/Exclusion Criteria apply

Treatments Being Tested

DRUG

ALN-HSD

Administered by subcutaneous injection (SC)

DRUG

Placebo

Administered by SC injection

Locations (20)

Arizona Liver Health
Chandler, Arizona, United States
The Institute for Liver Health II LLC DBA Arizona Clinical Trials - Flagstaff
Flagstaff, Arizona, United States
The Institute for Liver Health II LLC DBA Arizona Liver Health - Peoria
Peoria, Arizona, United States
Adobe Clinical Research
Tucson, Arizona, United States
Arizona Liver Health - Tucson
Tucson, Arizona, United States
Del Sol Research Management, LLC
Tucson, Arizona, United States
San Fernando Valley Health Institute
Canoga Park, California, United States
Velocity Clinical Research
Chula Vista, California, United States
Southern California Research Center
Coronado, California, United States
Ark Clinical Research - Fountain Valley
Fountain Valley, California, United States
Velocity Clinical Research
Gardena, California, United States
Velocity Clinical Research - Huntington Park
Huntington Park, California, United States
Om Research Llc
Lancaster, California, United States
Ark Clinical Research - Long Beach
Long Beach, California, United States
Velocity Clinical Research - Westlake
Los Angeles, California, United States
Clinnova Research Solutions
Orange, California, United States
Knowledge Research Center, St. Joseph's Medical Tower
Orange, California, United States
National Research Institute
Panorama City, California, United States
California Liver Research Institute
Pasadena, California, United States
Cadena Care Inst.
Poway, California, United States