What side effects are associated with this type of intervention?

Common treatments for Non-alcoholic Fatty Liver Disease (NAFLD) and Non-alcoholic Steatohepatitis (NASH) include pioglitazone, vitamin E, and liraglutide. Pioglitazone can cause weight gain, edema, and an increased risk of bone fractures. Vitamin E is generally well-tolerated but can increase the risk of hemorrhagic stroke and prostate cancer in high doses. Liraglutide may cause gastrointestinal issues such as nausea, vomiting, and diarrhea, and has been associated with an increased risk of pancreatitis. These side effects should be considered when discussing treatment options with a healthcare provider.

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). However, several drugs are under investigation, including those targeting specific genetic risk factors like the PNPLA3 148M allele. AZD2693 is one such investigational drug aimed at treating NASH in patients with this genetic risk. Other investigational treatments for NASH include agents targeting metabolic pathways, inflammation, and fibrosis, but none have yet received FDA approval.

What other types of research exist?

Promising alternatives to AZD2693 for treating NAFLD include FXR agonists like Px-102/Px-104, which are currently in phase IIa studies, and DGAT2 inhibitors such as PF-06427878, which have shown histological improvements in NASH in phase 1 studies. These agents target different pathways involved in liver disease and have demonstrated potential in clinical trials.

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AZD2693 for Non-alcoholic Steatohepatitis with Fibrosis (FORTUNA 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 64 weeks

Summary

This trial is testing a new medication called AZD2693, which is given as an injection under the skin. It is aimed at adults with a specific liver condition and a certain genetic marker. The goal is to see if it can reduce liver damage and improve liver function.

Who is the study for?

This trial is for adults aged 18-75 with non-cirrhotic non-alcoholic steatohepatitis (NASH) with fibrosis, who carry the PNPLA3 148M risk allele. They must have a liver biopsy showing NASH and fibrosis stage F2 or F3. Excluded are those with other liver diseases, severe kidney disease, abnormal blood counts or certain elevated liver enzymes.

What is being tested?

The study tests AZD2693's effectiveness and safety in treating NASH with fibrosis among carriers of the PNPLA3 risk allele. Participants will receive either AZD2693 or a placebo through subcutaneous injections to compare outcomes between the two groups.

What are the potential side effects?

While specific side effects of AZD2693 aren't listed, common reactions to subcutaneous injections may include pain at injection site, redness, swelling, itching and potential allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 64 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~64 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 64 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

Proportion of participants achieving NASH resolution without worsening of fibrosis based on histology after 52 weeks treatment

Secondary study objectives

Proportion of participants with at least one stage of liver fibrosis improvement with no worsening of NASH based on biopsy after 52 weeks treatment

Proportion of participants with improvement in fibrosis by at least one stage based on biopsy after 52 weeks treatment

Proportion of participants with ≥ 2-point improvement from baseline in NAS based on biopsy after 52 weeks treatment

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

3Treatment groups

Experimental Treatment

Placebo Group

Group I: AZD2693 dose 2Experimental Treatment1 Intervention

Participants will receive AZD2693 dose 2

Group II: AZD2693 dose 1Experimental Treatment1 Intervention

Participants will receive AZD2693 dose 1

Group III: PlaceboPlacebo Group1 Intervention

Participants in this arm will receive placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AZD2693

2023

Completed Phase 1

~230

Do I qualify?Apply below to find out

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) and Non-alcoholic Steatohepatitis (NASH) often target metabolic pathways, inflammation, and fibrosis. Agents like AZD2693, which target the PNPLA3 148M risk allele, aim to reduce liver fat accumulation and fibrosis by modulating genetic factors involved in lipid metabolism. Other treatments, such as pioglitazone and vitamin E, work by improving insulin sensitivity and reducing oxidative stress, respectively. Bile acid analogs like obeticholic acid activate farnesoid X receptors to improve lipid and glucose metabolism and reduce liver inflammation. These mechanisms are crucial for NAFLD patients as they address the underlying causes of liver damage, potentially halting disease progression and improving liver function.