What side effects are associated with this type of intervention?

Common treatments for Nonalcoholic Steatohepatitis (NASH) that target metabolic pathways, inflammation, or fibrosis include fibroblast growth factor 21 (FGF21) analogues and thyroid hormone receptor-beta agonists. Side effects of FGF21 analogues may include gastrointestinal symptoms, such as nausea and diarrhea, as well as potential changes in lipid profiles. Thyroid hormone receptor-beta agonists, like Resmetirom, can cause side effects such as increased liver enzymes, gastrointestinal disturbances, and potential cardiovascular effects. It is important for patients to discuss these potential side effects with their healthcare provider to manage and monitor any adverse reactions effectively.

What prior FDA approvals exist?

As of now, there are no FDA-approved drugs specifically for the treatment of Nonalcoholic Steatohepatitis (NASH). However, several investigational therapies are being studied, including those targeting metabolic pathways, inflammation, and fibrosis. For instance, drugs like obeticholic acid, a farnesoid X receptor (FXR) agonist, and elafibranor, a dual PPAR alpha/delta agonist, have shown promise in clinical trials. These therapies aim to improve liver histology by addressing underlying metabolic dysfunction, reducing inflammation, and preventing fibrosis progression.

What other types of research exist?

Promising novel alternatives for NASH treatment in 2024 include: 1) Evinacumab, an ANGPTL3 monoclonal antibody, which has shown significant LDL-C reduction and improvement in lipid profiles in clinical trials. 2) Thiazolidinediones, which are being studied for their potential to treat insulin resistance in NASH patients. 3) Vitamin E supplements, which may reduce liver damage in severe NASH cases without diabetes or heart disease, though evidence is mixed. 4) Weight loss through gradual lifestyle changes or bariatric surgery, which has shown improvement in liver conditions associated with NASH.

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K-877-ER + CSG452 for NASH

Phase 2

Recruiting

Research Sponsored by Kowa Research Institute, Inc.

Eligibility Criteria Checklist

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

Must have

Age ≥18 years

NAS ≥4 with a score of at least 1 in each component of the NAS (steatosis, lobular inflammation, and ballooning) at Visit 2 liver biopsy, or a historical liver biopsy performed within 12 weeks of randomization

Must not have

Evidence of other forms of chronic liver disease as defined in clinical study protocol

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 52 weeks

Summary

This trial is testing two new experimental drugs used together to treat adults with a serious liver disease. The combination is expected to be more effective than using each drug alone.

Who is the study for?

Adults with Nonalcoholic Steatohepatitis (NASH) and liver fibrosis can join this trial. They must have a minimum score on a liver health test, not be in another study recently, and not drink significant alcohol. Other chronic liver diseases or conditions outlined in the protocol also disqualify them.

What is being tested?

The trial is testing two experimental drugs, K-877-ER and CSG452, against a placebo to see if they're effective for treating NASH with liver fibrosis. Participants will randomly receive either the drugs or placebo.

What are the potential side effects?

Potential side effects are not specified here but may include typical drug reactions such as gastrointestinal issues, fatigue, allergic responses, or other organ-related inflammation due to the nature of the medications being tested.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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My liver biopsy shows a NAS of 4 or more with some steatosis, inflammation, and ballooning.

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My liver fibrosis stage is between 1 and below 4.

Exclusion Criteria

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

Select...

I have a long-term liver condition.

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

Improvement in disease activity and no worsening of liver fibrosis (Yes/No)

Secondary study objectives

Number of Participants With Treatment-Related Adverse Events (AE)

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: K-877-ERExperimental Treatment2 Interventions

K-877-ER and CSG452 Placebo QD

Group II: K-001Experimental Treatment2 Interventions

K-877-ER and CSG452 Once daily (QD)

Group III: CSG452Experimental Treatment2 Interventions

CSG452 and K-877-ER Placebo QD

Group IV: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

K-877-ER

2023

Completed Phase 1

~30

Tofogliflozin

Not yet FDA approved

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 Nonalcoholic Steatohepatitis (NASH) target metabolic pathways, inflammation, and fibrosis. Drugs like GLP-1 receptor agonists improve glucose and lipid metabolism, reducing hepatic fat content. Anti-inflammatory agents aim to decrease liver inflammation, a key driver of NASH progression. Antifibrotic therapies work to prevent or reverse liver fibrosis, which is critical as fibrosis is a major determinant of long-term outcomes in NASH patients. These mechanisms are essential as they address the root causes of NASH, offering the potential for more effective management and improved patient prognosis.

Investigating the in vitro steatotic mixture effects of similarly and dissimilarly acting test compounds using an adverse outcome pathway-based approach.Nutrition and Nonalcoholic Fatty Liver Disease: Current Perspectives.Current and Emerging Therapies for Non-alcoholic Fatty Liver Disease.