Study on the Safety and Effects of AZD4831 for Adults with Non-Cirrhotic Non-Alcoholic Steatohepatitis (NASH) with Fibrosis

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What is this study about?

This clinical trial is focused on studying Non-Alcoholic Steatohepatitis (NASH), a liver disease that can progress from a condition known as Non-Alcoholic Fatty Liver Disease (NAFLD). NASH is characterized by liver inflammation and damage due to fat buildup, and it can lead to more severe liver issues like cirrhosis or liver cancer. The study will evaluate a treatment called AZD4831, which is administered as a film-coated tablet. Participants will either receive AZD4831 or a placebo, which is a substance with no active medication.

The purpose of the study is to assess the safety and tolerability of AZD4831 in adults with NASH who do not have cirrhosis but do have liver fibrosis, which is a type of scarring. The study will also look at how the body processes the drug. Participants will be randomly assigned to receive either AZD4831 or a placebo, and neither the participants nor the researchers will know who is receiving which treatment. The study will last for about 12 weeks, during which time participants will have regular check-ups to monitor their health and the effects of the treatment.

Throughout the study, participants will have their liver function and other health markers checked to see how they change over time. The main focus will be on changes in liver enzymes, which are indicators of liver health. The study aims to provide valuable information on the potential benefits and safety of AZD4831 for people with NASH, which could lead to new treatment options for this condition in the future.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, you will undergo a series of assessments to confirm your eligibility for the trial. These assessments may include a review of your medical history, a physical examination, and laboratory tests.

You will be asked to provide informed consent, which means you agree to participate in the study after understanding all the details and potential risks involved.

2 randomization

Once eligibility is confirmed, you will be randomly assigned to one of two groups. One group will receive the study medication, AZD4831, and the other group will receive a placebo, which looks like the medication but does not contain the active ingredient.

This process is double-blind, meaning neither you nor the study team will know which group you are in, to ensure unbiased results.

3 medication administration

If you are assigned to the group receiving AZD4831, you will take the medication in the form of a film-coated tablet. The dosage and frequency will be determined by the study protocol, and you will be instructed on how to take the medication correctly.

The duration of the medication administration is planned for 12 weeks. You will be required to take the medication as directed and report any side effects or issues to the study team.

4 follow-up visits

Throughout the study, you will attend regular follow-up visits. These visits are scheduled to monitor your health and the effects of the medication. They may include physical exams, blood tests, and other assessments.

The study team will track changes in specific health markers, such as liver enzyme levels, to evaluate the safety and effectiveness of the treatment.

5 end of study

At the end of the 12-week period, you will have a final visit. During this visit, the study team will conduct a comprehensive assessment to gather final data on your health status.

You will be informed about the next steps, including any follow-up care or additional studies you may be eligible for.

Who Can Join the Study?

Participant must be between 18 and 75 years old at the time of signing the consent form.
Participants must have a confirmed diagnosis of Non-Alcoholic Steatohepatitis (NASH) through a liver biopsy done within the last 12 months. If no previous biopsy is available, participants should be willing to undergo a liver biopsy during the screening process.
If the participant has Type 2 Diabetes Mellitus (T2DM), their Hemoglobin A1c level must be 9.5% or lower. Hemoglobin A1c is a blood test that shows average blood sugar levels over the past 2 to 3 months.
Participants must have at least one elevated serum ALT measurement. ALT is a liver enzyme, and elevated levels can indicate liver damage.
Participants can have diabetes or not. If they are taking certain diabetes medications like GLP-1 receptor agonists, SGLT2 inhibitors, or pioglitazone, the medication must be stable for at least 6 months before joining the study.
Participants must have a stable weight for at least 3 months before joining the study. Stable weight means no more than a 5% change in body weight.
Both males and females can participate. Female participants must not be pregnant or breastfeeding. Women of childbearing potential must agree to use an acceptable method of birth control during the study and for at least 4 weeks after the last dose of the study medication.
Participants must be able to give signed informed consent, which means they understand the study and agree to follow its requirements.
Participants must provide signed consent for optional genetic research, which involves collecting samples for genetic studies.

Who Cannot Join the Study?

Patients with a history of alcohol abuse cannot participate. This means if you have had problems with drinking too much alcohol in the past, you may not be eligible.
Patients with other liver diseases besides NASH are excluded. If you have liver problems that are not related to NASH, you cannot join the study.
Patients with uncontrolled diabetes are not allowed. This means if your blood sugar levels are not well-managed, you may not be eligible.
Patients with severe heart problems cannot participate. If you have serious heart conditions, you are not eligible for the study.
Patients who are pregnant or breastfeeding are excluded. If you are expecting a baby or nursing, you cannot join the study.
Patients with active cancer are not allowed. If you currently have cancer, you cannot participate in the study.
Patients who have had a liver transplant are excluded. If you have received a new liver, you cannot join the study.
Patients with severe kidney problems cannot participate. If your kidneys are not working well, you are not eligible for the study.
Patients who are taking certain medications that affect the liver are excluded. If you are on drugs that impact liver function, you cannot join the study.
Patients with uncontrolled high blood pressure are not allowed. If your blood pressure is not well-managed, you may not be eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Sydvestjysk Sygehus	Esbjerg	Denmark
Region Oestergoetland	Linkoping	Sweden
IRCCS Humanitas Research Hospital	Rozzano	Italy
Bispebjerg Hospital	Copenhagen	Denmark
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy

Other Sites

Site Name	City	Country
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Ospedale San Raffaele S.r.l.	Milan	Italy
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida	Lleida	Spain
Universitetssykehuset Nord-Norge HF	Tromsø	Norway
Sykehuset Oestfold HF Kalnes	Graalum	Norway
Universita’ Campus Bio-medico Di Roma	Rome	Italy
Hospital General Universitario De Valencia	Valencia	Spain
Casa Sollievo Della Sofferenza	San Giovanni Rotondo	Italy
APDP Associacao Protectora Dos Diabeticos De Portugal	Lisbon	Portugal
Lovisenberg Diakonale Sykehus AS	Oslo	Norway
Zealand University Hospital	Koege	Denmark
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Abfwyve Oyhtldveerl Upqmburcinuxs Odositvr Rjutyfe	Foggia	Italy
Oxrqsxjx Gqsnhwukc	Catania	Italy
Ajsithdq Uscqzagnxa Htescwcj	Lorenskog	Norway
Uzvcbuu Ugmivwbnfj Hjqjrpjc	Uppsala	Sweden
Awqyfh Uwhswpzhhj Hqawniir	Aarhus	Denmark
Amrtlct Olojtsegscj Uxzljfikgkunk Cbkloubsdaqd Dfglf Sbzfrd E Dllno Syxgphe Dx Tvybni	Turin	Italy
Hmmyccku Ugmsdlpvtbvue Mkcfiuu Db Vnyfqfavaj	Santander	Spain
Fdkybovkn Psog Lb Igtnavtofmjdv Bjqtvebhx Dor Hgmmgtpm Ugyxurvwhcxzf Lm Pqb	Madrid	Spain
Hfbsjbeu Uzxaxfkjfzite dg A Clfnhh	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	31.10.2022
Italy	Not recruiting	31.10.2022
Norway	Not recruiting	31.10.2022
Portugal	Not recruiting	31.10.2022
Spain	Not recruiting	31.10.2022
Sweden	Not recruiting	31.10.2022

Trial locations

Investigated drugs:

Azd4831

AZD4831 is a medication being studied for its potential to help people with a liver condition called non-cirrhotic non-alcoholic steatohepatitis (NASH) with fibrosis. This condition involves the buildup of fat in the liver, which can lead to liver damage over time. The medication is being tested to see if it is safe and well-tolerated by patients, and to understand how it affects the body. The goal is to see if it can help reduce liver damage and improve liver health in people with this condition.

Non-Alcoholic Steatohepatitis (NASH) – Non-Alcoholic Steatohepatitis is a progressive liver disease that is a more severe form of Non-Alcoholic Fatty Liver Disease (NAFLD). It is characterized by the accumulation of fat in the liver, along with inflammation and damage to liver cells. Unlike simple fatty liver, NASH involves liver cell injury and inflammation due to the buildup of harmful fat byproducts. This condition is often linked to metabolic issues such as obesity, type 2 diabetes, and abnormal cholesterol levels. NASH can lead to the development of liver fibrosis, where scar tissue forms in the liver. Over time, this fibrosis can progress, potentially leading to more severe liver damage.

Trial ID:

2022-500594-13-00

Protocol code:

D6581C00001

NCT ID:

NCT05638737

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Safety and Effects of AZD4831 for Adults with Non-Cirrhotic Non-Alcoholic Steatohepatitis (NASH) with Fibrosis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?