What side effects are associated with this type of intervention?

Common treatments for Non-alcoholic Fatty Liver Disease (NAFLD) include weight loss through lifestyle changes, thiazolidinediones (e.g., pioglitazone), and incretin-based therapies (e.g., liraglutide). Weight loss is generally safe but may cause nutritional deficiencies if not managed properly. Thiazolidinediones can lead to weight gain, fluid retention, and an increased risk of bone fractures. Incretin-based therapies may cause gastrointestinal issues such as nausea and diarrhea. Similar to these treatments, VK2809, which is under study for long-term efficacy and safety, may also have side effects that need careful monitoring over time.

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). Various drugs are under investigation, including those targeting metabolic pathways and liver fibrosis, but none have received official approval. Lifestyle modifications remain the primary recommendation for managing these conditions.

What other types of research exist?

Promising novel alternatives for NAFLD treatment include obeticholic acid, resmetirom, aramchol, efruxifermin, aldafermin, and lanifibranor. These drugs have demonstrated potential in resolving NASH and improving fibrosis. Additionally, antidiabetic medications like PPAR-γ agonists and glucagon-like peptide receptor agonists have shown beneficial effects on both the metabolic profile and NASH histology.

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VK2809 for NASH (VOYAGE Trial)

Phase 2

Waitlist Available

Research Sponsored by Viking Therapeutics, Inc.

Eligibility Criteria Checklist

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

Must have

Have a histologically-confirmed diagnosis of NASH on a liver biopsy performed during screening or within 6 months before screening with NASH CRN fibrosis stage 1 to stage 3 and NAS of ≥4 with specific criteria

Male and females be 18 to 75 years of age, inclusive, at screening

Must not have

Are unwilling to undergo the required liver biopsy procedures or have any condition preventing obtaining a liver biopsy

Use of strong or moderate inhibitors or inducers of CYP3A4

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 52 weeks

Summary

This trial is testing a new medication with 337 participants. The participants are equally divided by gender and categorized by fibrosis stage and diabetes status. The study will observe how the medication affects these different groups over time.

Who is the study for?

This trial is for adults aged 18-75 with a confirmed diagnosis of NASH (a type of liver disease) and certain risk factors like diabetes or obesity. Participants must have had a recent liver biopsy showing specific levels of liver damage and fat, be willing to undergo another biopsy, and not drink excessively. They can't join if they've used weight loss drugs recently, have abnormal thyroid or liver tests, take certain other medications, or have heart issues.

What is being tested?

The study is testing the safety and effectiveness of VK2809 over a year compared to a placebo. It's double-blind so neither participants nor doctors know who gets what treatment. Subjects visit the clinic every four weeks after randomization into one of five groups with equal numbers of men and women, stratified by fibrosis stage and diabetes status.

What are the potential side effects?

While the potential side effects are not listed in this summary, common considerations for trials like this may include gastrointestinal discomforts such as nausea or diarrhea, headaches, fatigue, possible allergic reactions to the drug components among others.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My liver biopsy confirms I have NASH with specific fibrosis and activity levels.

Select...

I am between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am unwilling or unable to have a liver biopsy.

Select...

I am not taking any strong or moderate drugs that affect liver enzymes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~52 weeks

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

Treatment Details

Study Objectives

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

Primary study objectives

Liver Fat

Secondary study objectives

NASH CRN fibrosis score

Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

Group I: 5.0 mgExperimental Treatment1 Intervention

Group II: 2.5mgExperimental Treatment1 Intervention

Group III: 10 mgExperimental Treatment1 Intervention

Group IV: 1.0 mgExperimental Treatment1 Intervention

Group V: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

VK2809

2019

Completed Phase 2

~310

0 / 4Eligibility criteria met

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) include statins, GLP-1 receptor agonists, and omega-3 fatty acids. Statins lower lipid levels, reducing liver fat. GLP-1 receptor agonists like liraglutide and semaglutide improve insulin sensitivity and promote weight loss, addressing obesity-related inflammation. Omega-3 fatty acids reduce liver fat and inflammation. These mechanisms are vital for NAFLD patients as they target the core issues of fat accumulation, insulin resistance, and inflammation, potentially preventing progression to more severe liver conditions.

Cross-talk between non-alcoholic fatty liver disease and cardiovascular disease: implications for future trial design.Treatments of nonalcoholic fatty liver disease in adults who have no other illness: A Review article.Pharmacological interventions for non-alcoholic fatty liver disease: a systematic review and network meta-analysis.