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Study on AZD2693 for Adults with Non-Cirrhotic Non-Alcoholic Steatohepatitis and PNPLA3 Genetic Marker

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a liver condition called Non-alcoholic Steatohepatitis (NASH), which occurs in people who do not consume excessive alcohol and have liver inflammation and damage due to a buildup of fat in the liver. The study specifically targets individuals with NASH who have a genetic marker known as the PNPLA3 rs738409 148M risk allele and have liver fibrosis, which is a type of scarring in the liver. The treatment being tested is a medication called AZD2693, which is given as a solution for injection under the skin. The purpose of the study is to evaluate the effectiveness, safety, and tolerability of AZD2693 compared to a placebo in resolving NASH without worsening liver fibrosis over a period of 52 weeks.

Participants in the study will receive either the AZD2693 injection or a placebo injection. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure that the results are not biased. The study will last for about a year, during which participants will be monitored for any changes in their liver condition, specifically looking for improvements in liver inflammation and scarring.

The main goal is to see if AZD2693 can help resolve NASH without worsening liver fibrosis. Secondary goals include assessing whether there is an improvement in liver fibrosis and overall liver health. Participants will undergo various assessments, including liver biopsies, to evaluate the effects of the treatment. The study aims to provide valuable information on the potential benefits of AZD2693 for people with NASH and liver fibrosis who carry the PNPLA3 genetic marker.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria. Participants must be between 18 and 75 years old and carry the PNPLA3 rs738409 148M genetic marker.
A liver biopsy is required to confirm the presence of non-cirrhotic non-alcoholic steatohepatitis (NASH) with fibrosis. This biopsy must show a NASH activity score of 4 or more, with at least 1 in each component: steatosis, lobular inflammation, and ballooning.
Step 2
Treatment phase
Participants receive either the investigational drug AZD2693 or a placebo. The medication is administered as a subcutaneous injection.
The treatment lasts for 52 weeks. The goal is to assess the effect of AZD2693 on the resolution of NASH without worsening liver fibrosis.
Step 3
Monitoring and assessments
Throughout the study, regular monitoring and assessments are conducted to evaluate the safety and effectiveness of the treatment.
Primary assessments focus on the resolution of NASH and any changes in liver fibrosis. Secondary assessments include improvements in liver fibrosis and NASH activity score.
Step 4
End of treatment evaluation
After 52 weeks, a final evaluation is conducted to determine the treatment's impact on NASH and liver fibrosis.
The study aims to achieve a resolution of NASH, defined by specific scores for ballooning, inflammation, and steatosis, without worsening fibrosis.

Who can join the trial?

5 criteria

The participant must be between 18 and 75 years old at the time of signing the informed consent.
The participant must have a specific genetic marker called the **PNPLA3 rs738409 148M risk allele**.
The participant must have **non-alcoholic steatohepatitis (NASH)**, which is a liver condition, confirmed by a liver biopsy. This biopsy must have been done up to 6 months before joining the study or during the screening process.
The liver biopsy must show a **NASH Activity Score (NAS)** of 4 or higher, with at least 1 point in each of the following areas: **steatosis** (fat in the liver), **lobular inflammation** (swelling in the liver), and **ballooning** (damaged liver cells).
The participant must have **fibrosis**, which is scarring of the liver, at stage F2 or F3 according to a specific grading system used for NASH.

Who cannot join the trial?

10 criteria

Individuals with other liver diseases, not related to the study condition, cannot participate.
People who have had significant alcohol consumption recently are excluded.
Participants with a history of liver cirrhosis, which is severe liver scarring, are not eligible.
Those who have had a liver transplant cannot join the study.
Individuals with certain serious heart conditions are excluded.
People with uncontrolled diabetes, which means their blood sugar levels are not well managed, cannot participate.
Participants who are pregnant or breastfeeding are not eligible.
Individuals who are currently participating in another clinical trial are excluded.
People with a history of certain types of cancer may not be eligible.
Participants with known allergies to the study medication cannot join.

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Verified sites

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Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Verified
Palermo, Italy
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz
Verified
Mainz, Germany
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Verified
Milan, Italy

Trial locations

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Investigated drugs

AZD2693 is an investigational medication being studied for its potential to treat non-cirrhotic non-alcoholic steatohepatitis (NASH) with fibrosis. This medication is specifically being tested in individuals who carry a particular genetic risk factor known as the PNPLA3 rs738409 148M allele. The goal of the study is to see if AZD2693 can help improve liver health by resolving NASH, which is a liver condition characterized by fat buildup and inflammation, over a period of 52 weeks.

Azd2693 Sodium

What is already known about the treatment

AZD2693 – AZD2693 is an investigational medication currently being studied in clinical trials for its potential to treat non-cirrhotic non-alcoholic steatohepatitis (NASH) with fibrosis, particularly in individuals carrying a specific genetic risk factor known as the PNPLA3 rs738409 148M allele. It is administered orally, allowing for easy intake. The medication is in the Phase 2b stage of clinical trials, where its efficacy, safety, and tolerability are being evaluated. AZD2693 works by targeting specific molecular pathways involved in liver inflammation and fibrosis, aiming to improve liver health and reduce disease progression. It is classified as a therapeutic agent for liver diseases, specifically focusing on conditions related to fat accumulation and fibrosis in the liver.

Investigated diseases

Non-cirrhotic non-alcoholic steatohepatitis with fibrosis – This disease is a liver condition characterized by inflammation and damage to liver cells, along with fat accumulation, in individuals who do not consume excessive alcohol. It progresses with the development of fibrosis, which is the formation of scar tissue in the liver. Over time, the liver's ability to function properly may be affected due to the ongoing inflammation and scarring. The condition is often associated with metabolic factors such as obesity and insulin resistance. It is important to monitor the progression of fibrosis, as it can lead to more severe liver issues if not managed.