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

Conditions

• Metabolic Dysfunction-Associated SteatoHepatitis (MASH)

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• ALN-HSD — DRUG
  Administered per the protocol
• Placebo — DRUG
  Administered per the protocol

Study Details

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 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

Key Dates

Start date

Feb 9, 2023

Status verified

May 2026

Primary completion

Apr 27, 2028

Completion

Dec 7, 2028

Study Design

Enrollment

120 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: ALN-HSD
  Randomized 1:1
• Placebo Comparator: Placebo
  Randomized 1:1

Primary Outcome Measure

Change in quantitative liver Fibrosis (qFibrosis) [ Time Frame: Baseline to week 52 ]

Central Contacts

• Clinical Trials Administrator
  844-734-6643
  [email protected]

Locations (61)

Find similar trials in Chandler, AZ

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