What side effects are associated with this type of intervention?

Common treatments for Non-alcoholic Fatty Liver Disease (NAFLD) include silymarin, berberine, pioglitazone, liraglutide, sitagliptin, and FGF21 analogues. Silymarin and berberine are generally well-tolerated but can cause gastrointestinal issues such as nausea and diarrhea. Pioglitazone may lead to weight gain, edema, and an increased risk of bone fractures. Liraglutide can cause gastrointestinal side effects like nausea and vomiting, and has a potential risk for pancreatitis. Sitagliptin is usually well-tolerated but may cause upper respiratory tract infections and headaches. FGF21 analogues, while still under investigation, have shown mild side effects such as injection site reactions and gastrointestinal discomfort.

What prior FDA approvals exist?

As of now, there are no FDA-approved medications specifically for the treatment of Non-alcoholic Fatty Liver Disease (NAFLD). However, several drugs are being studied for their potential benefits in NAFLD and Non-alcoholic Steatohepatitis (NASH), a more severe form of NAFLD. These include rencofilstat, a cyclophilin inhibitor, which has shown antifibrotic effects in preclinical models and early-phase clinical trials. Other investigational drugs include GLP-1 receptor agonists like liraglutide and semaglutide, which are primarily used for diabetes and obesity but have shown promise in reducing liver fat and inflammation. The HM15211 trial is another ongoing study evaluating a new treatment for NASH, though its specific mechanism of action is not detailed in the provided context.

What other types of research exist?

Promising novel alternatives to HM15211 for NAFLD patients include: 1) Polyethylene glycol 3350 (PEG 3350) and lactulose, which have been shown to reduce hepatic inflammation and decrease hepatic steatosis (HS) and body weight in mice. 2) Chalcone derivative L6H21, which inhibits liver steatosis and injury through suppression of NLRP3 inflammasome activation. 3) Selective Glucocorticoid Receptor Modulator CORT118335, which prevents and reverses NAFLD by stimulating lipid efflux from the liver without increasing hepatic fatty acid uptake. 4) FXR agonists like Px-102/Px-104, currently in phase IIa studies, which target the FXR ligand binding pocket to improve liver function. 5) lncNONMMUG027912, which alleviates lipid accumulation through the AMPKα/mTOR/SREBP1C signaling axis.

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HM15211 for Non-alcoholic Steatohepatitis (NASH)

Phase 2

Recruiting

Research Sponsored by Hanmi Pharmaceutical Company Limited

Eligibility Criteria Checklist

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

Must have

Adults ≥ 18 to ≤ 70 years.

Be older than 18 years old

Must not have

Recent (within 3 months of baseline biopsy) use of therapies associated with development of NAFLD (e.g., systemic corticosteroids, methotrexate, tamoxifen, aromatase inhibitors, amiodarone, or long-term use of tetracyclines).

Any history of clinically significant chronic liver disease including esophageal varices, ascites, hepatic encephalopathy, splenomegaly, or any hospitalization for treatment of chronic liver disease; or Model for End Stage Liver Disease >12.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Summary

This trial is testing a medication called HM15211 to see if it can help people with a liver disease called NASH. The study will check if the medication is safe and effective over a period of time.

Who is the study for?

Adults aged 18-70 with non-cirrhotic NASH and liver fibrosis stages F1-F3, confirmed by a biopsy within the last 6 months. Participants must have at least 8% liver fat on MRI-PDFF and a stable body weight for the past three months. Excluded are those with significant chronic liver diseases, recent use of certain NAFLD-related therapies, Type 1 diabetes or specific Type 2 diabetes treatments.

What is being tested?

The trial is testing HM15211's effectiveness over a year in treating NASH compared to a placebo. It's designed to see if this treatment can improve fatty liver disease without causing harm or discomfort to patients.

What are the potential side effects?

While not specified here, common side effects for similar treatments may include gastrointestinal issues like nausea or diarrhea, potential allergic reactions, fatigue, headaches and possibly an impact on blood sugar levels.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 70 years old.

Exclusion Criteria

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

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I have used medications recently that could cause fatty liver disease.

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I have never had serious liver disease or been hospitalized for it.

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I have a history of liver disease or HIV.

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I have type 1 diabetes or type 2 diabetes treated with insulin or GLP-1 receptor agonists.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

pharmacodynamic (PD) effect of HM15211

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: HM15211Experimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

HM15211

2018

Completed Phase 1

~70

0 / 5Eligibility 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) target various molecular pathways to reduce liver fat, inflammation, and fibrosis. These include lifestyle modifications such as diet and exercise, which improve insulin sensitivity and reduce liver fat. Pharmacologic treatments often involve the use of pioglitazone, which enhances insulin sensitivity, and GLP-1 receptor agonists like liraglutide, which promote weight loss and reduce liver fat. Emerging therapies, such as those targeting ANGPTL3, aim to lower triglycerides and LDL-C levels. These mechanisms are crucial for NAFLD patients as they address the underlying metabolic dysfunctions, potentially halting disease progression and improving liver health.

Nutrition and Nonalcoholic Fatty Liver Disease: Current Perspectives.Molecular mechanisms and the role of saturated fatty acids in the progression of non-alcoholic fatty liver disease.