What side effects are associated with this type of intervention?

Common treatments for Non-alcoholic Fatty Liver Disease (NAFLD) that aim to reduce inflammation and fibrosis, such as pioglitazone, vitamin E, FGF21 analogues, and thyroid hormone receptor-beta agonists, have various side effects. Pioglitazone can cause weight gain, edema, and an increased risk of bone fractures. Vitamin E, while generally well-tolerated, may increase the risk of hemorrhagic stroke and prostate cancer with long-term use. FGF21 analogues may lead to gastrointestinal disturbances and injection site reactions. Thyroid hormone receptor-beta agonists can cause mild increases in liver enzymes and potential cardiovascular effects. Patients should discuss these potential side effects with their healthcare provider to make an informed decision.

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) that target inflammation and fibrosis directly. However, several drugs have been studied for their potential benefits in NAFLD, including pioglitazone and vitamin E, which have shown some efficacy in reducing liver inflammation and fibrosis. Additionally, obeticholic acid, a farnesoid X receptor agonist, has been investigated for its role in improving liver histology in patients with non-alcoholic steatohepatitis (NASH), a more severe form of NAFLD. These treatments aim to address the underlying metabolic dysfunctions and inflammatory processes associated with the disease.

What other types of research exist?

Promising novel alternatives to AZD4831 for NAFLD/NASH treatment include: 1) Cilofexor, a nonsteroidal FXR agonist, which has shown efficacy in reducing liver fat and stiffness in a phase 2 trial. 2) Electrophilic nitro-oleic acid (NO2-OA), which has anti-inflammatory and antioxidant properties. 3) PEG 3350 and lactulose, which have demonstrated reduction in hepatic inflammation in animal models. 4) CXCR2 antagonist AZD5069, which improves insulin sensitivity and reduces liver pathology. 5) PF-06427878, which has shown histological improvements in liver steatosis, ballooning, and fibrosis in phase 1 studies.

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AZD4831 for NASH with Fibrosis (COSMOS Trial)

Phase 2

Waitlist Available

Research Sponsored by AstraZeneca

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 12 weeks

Summary

This trial is testing a new drug called AZD4831 to see if it can help people with a liver condition known as NASH, which causes liver damage and scarring. The study involves adults who have been diagnosed with NASH but do not have cirrhosis. Researchers hope that AZD4831 will reduce liver inflammation and scarring.

Who is the study for?

Adults aged 18-75 with Non-alcoholic Steatohepatitis (NASH) and liver fibrosis, confirmed by biopsy, can join this trial. They should have a history of increased liver enzymes but no other liver diseases or recent use of weight loss drugs or treatments that could affect the fatty liver.

What is being tested?

The study is testing AZD4831 against a placebo to see its effects on NASH with fibrosis. Participants will be randomly assigned to either the drug or placebo for 12 weeks and monitored for an additional 4 weeks after treatment ends.

What are the potential side effects?

Specific side effects are not listed, but participants may experience unexpected reactions due to the experimental nature of AZD4831. The safety follow-up period helps identify any potential adverse events from the treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

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

Change from baseline and over placebo to Week 12 - ALT

Secondary study objectives

Change from baseline over placebo to Week 12 - Pro-C3

Plasma concentration of AZD4831 (Ctrough)

Other study objectives

Number of participants with Adverse Events/Serious Adverse Events (AEs/SAEs) and abnormal clinical test results

Number of participants with Adverse Events/Serious Adverse Events (AEs/SAEs) and abnormal laboratory test results

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: AZD4831Experimental Treatment1 Intervention

AZD4831

Group II: PlaceboPlacebo Group1 Intervention

Placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AZD4831

2022

Completed Phase 3

~990

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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) target reducing liver inflammation and fibrosis, which are critical in preventing disease progression. For instance, pioglitazone, a PPAR-gamma agonist, improves insulin sensitivity and reduces liver fat. Obeticholic acid, a farnesoid X receptor agonist, decreases liver inflammation and fibrosis by modulating bile acid pathways. Additionally, GLP-1 receptor agonists like liraglutide enhance insulin secretion and reduce hepatic fat content. These treatments are crucial for NAFLD patients as they address the underlying mechanisms of liver damage, potentially halting or reversing disease progression.