What is the mechanism of action of this treatment?

Common treatments for Non-alcoholic Fatty Liver Disease (NAFLD) often focus on metabolic regulation and anti-inflammatory effects to address the core issues of liver fat accumulation, inflammation, and fibrosis. For instance, Pemvidutide, currently under study, likely works by regulating metabolism and reducing inflammation. Similarly, fibroblast growth factor 21 (FGF21) analogues enhance fatty acid oxidation and inhibit lipogenesis, while thyroid hormone receptor-beta agonists improve lipid metabolism. These mechanisms are crucial for NAFLD patients as they directly target the disease's progression, potentially reversing liver damage and improving overall liver function.

What side effects are associated with this type of intervention?

Common treatments for Non-alcoholic Fatty Liver Disease (NAFLD) include Pioglitazone and Vitamin E. Pioglitazone, a thiazolidinedione, can cause weight gain, edema, and an increased risk of heart failure. Vitamin E, an antioxidant, is generally well-tolerated but can increase the risk of hemorrhagic stroke when taken in high doses. Emerging treatments targeting metabolic regulation and anti-inflammatory pathways, like Pemvidutide, may have side effects such as gastrointestinal disturbances, injection site reactions, and potential metabolic imbalances. Patients should discuss these risks with their healthcare provider to determine the most appropriate treatment plan.

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) or Non-alcoholic Steatohepatitis (NASH). However, several drugs are being studied for their potential benefits. These include agents like obeticholic acid, which targets bile acid pathways to improve liver fibrosis, and metformin, which has shown some promise in reducing liver fat and inflammation through its effects on insulin resistance. Other investigational drugs, such as pemafibrate, aim to modulate lipid metabolism and reduce liver inflammation and fibrosis, similar to the mechanisms being studied for Pemvidutide.

What other types of research exist?

Promising alternatives to Pemvidutide for NAFLD treatment include Exenatide, which ameliorates hepatic steatosis and reduces fat mass through the PI3K signaling pathway, and Liraglutide, which has shown safety and efficacy in reducing liver fat and inflammation in patients with non-alcoholic steatohepatitis (NASH). Additionally, Pemafibrate, a selective PPAR-alpha modulator, has demonstrated improvements in liver dysfunction and insulin resistance in rodent models of NASH.

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Glucagon-like peptide-1 (GLP-1) receptor agonist

Pemvidutide for Nonalcoholic Steatohepatitis (NASH) (IMPACT Trial)

Phase 2

Waitlist Available

Research Sponsored by Altimmune, Inc.

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 up to 5 years

Summary

This trial is testing pemvidutide, a medication that may help treat NASH, a liver disease. It aims to see if the drug can reduce liver damage and help the liver heal.

Who is the study for?

Adults aged 18-75 with moderate to severe NASH (stages 2-3 fibrosis) can join this trial. They must have a confirmed diagnosis, certain levels of liver fat and inflammation, and meet criteria for Metabolic Syndrome. Those with Type 1 diabetes, recent significant weight changes, or very high liver enzymes cannot participate.

What is being tested?

The IMPACT Trial is testing Pemvidutide's effectiveness on resolving NASH without worsening fibrosis compared to a placebo. Participants will be randomly assigned to receive either the drug or placebo and will undergo liver biopsies before and after treatment.

What are the potential side effects?

Potential side effects of Pemvidutide are not detailed here but may include typical drug reactions such as nausea, headache, fatigue, injection site reactions, and possible impacts on blood sugar control in diabetics.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Pemvidutide 1.8 mg (n=76)Experimental Treatment1 Intervention

Group II: Pemvidutide 1.2 mg (n=38)Experimental Treatment1 Intervention

Group III: Placebo (n=76)Placebo Group1 Intervention

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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) often focus on metabolic regulation and anti-inflammatory effects to address the core issues of liver fat accumulation, inflammation, and fibrosis. For instance, Pemvidutide, currently under study, likely works by regulating metabolism and reducing inflammation. Similarly, fibroblast growth factor 21 (FGF21) analogues enhance fatty acid oxidation and inhibit lipogenesis, while thyroid hormone receptor-beta agonists improve lipid metabolism. These mechanisms are crucial for NAFLD patients as they directly target the disease's progression, potentially reversing liver damage and improving overall liver function.

Molecular mechanisms and the role of saturated fatty acids in the progression of non-alcoholic fatty liver disease.