What side effects are associated with this type of intervention?

Common treatments for Non-alcoholic Fatty Liver Disease (NAFLD) and Non-alcoholic Steatohepatitis (NASH) include lipid-lowering agents like statins, anti-diabetic medications such as pioglitazone, and antioxidants like vitamin E. Statins are generally well-tolerated but can cause muscle pain, liver enzyme abnormalities, and, rarely, rhabdomyolysis. Pioglitazone may lead to weight gain, edema, and an increased risk of heart failure. Vitamin E is usually safe but can cause gastrointestinal issues and, at high doses, an increased risk of hemorrhagic stroke. These treatments aim to reduce liver fat, inflammation, and fibrosis, similar to the investigational drug ALN-HSD.

What prior FDA approvals exist?

As of now, there are no FDA-approved drugs specifically for the treatment of Non-Alcoholic Fatty Liver Disease (NAFLD) or Non-Alcoholic Steatohepatitis (NASH). Current management primarily focuses on lifestyle modifications such as diet and exercise. Some investigational drugs, like ALN-HSD, are being studied for their potential to reduce liver scarring and improve liver function in NASH patients. These investigational therapies often target specific pathways involved in liver inflammation and fibrosis, similar to the gene-silencing approach of ALN-HSD.

What other types of research exist?

Promising alternatives to ALN-HSD for NAFLD/NASH patients include Aldafermin, which is an FGF-19 analogue showing efficacy in reducing liver fibrosis without tumorigenic effects, and Lanifibranor, which has a high probability of improving fibrosis without worsening NASH. Additionally, Obeticholic acid has shown similar potential in improving liver histology. These alternatives have demonstrated promising results in clinical studies and could be considered for treatment in 2024.

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RNAi Therapeutics

ALN-HSD for NASH with Fibrosis (NASHGEN-2 Trial)

Phase 2

Recruiting

Research Sponsored by Regeneron Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 52

Summary

This trial is testing a new drug called ALN-HSD to help people with a liver disease called NASH. NASH causes fat to build up in the liver, leading to damage and scarring. The drug aims to reduce this damage and improve liver health.

Who is the study for?

This trial is for adults with a condition called NASH, where fat buildup leads to liver inflammation and scarring. Participants must have a certain level of liver damage (stage 2 or 3 fibrosis) and meet specific genetic criteria.

What is being tested?

The study tests ALN-HSD, an investigational drug, against a placebo to see if it can reduce liver scarring in NASH patients. It also examines how the body processes the drug and its effects on liver function and inflammation.

What are the potential side effects?

Potential side effects from ALN-HSD are not detailed here but typically could include reactions at the injection site, gastrointestinal symptoms, fatigue, headache, and possible abnormal blood tests reflecting liver or kidney function.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in qFibrosis

Secondary study objectives

Improvement of non-alcoholic steatohepatitis clinical research network (NASH-CRN) fibrosis (F) stage by ≥1 stage without worsening of NASH

Resolution of NASH with no worsening of NASH-CRN fibrosis on liver biopsy

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ALN-HSDExperimental Treatment1 Intervention

Randomized 1:1

Group II: PlaceboPlacebo Group1 Intervention

Randomized 1:1

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Non-alcoholic Fatty Liver Disease (NAFLD) and Non-alcoholic Steatohepatitis (NASH) often focus on reducing liver inflammation, fibrosis, and improving liver function. The investigational drug ALN-HSD, for example, aims to lessen liver scarring and inflammation by targeting specific molecular pathways involved in these processes. Other treatments, such as pioglitazone and vitamin E, work by improving insulin sensitivity and reducing oxidative stress, respectively. These mechanisms are crucial for NAFLD patients as they help to prevent the progression of liver damage, reduce the risk of cirrhosis, and improve overall liver health.

A Biomedical Investigation of the Hepatoprotective Effect of Radix salviae miltiorrhizae and Network Pharmacology-Based Prediction of the Active Compounds and Molecular Targets.