Study on Efruxifermin for Patients with Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) or Metabolic Dysfunction-Associated Steatohepatitis (MASH)

3 1

What is this study about?

This clinical trial is focused on studying the effects of a treatment called Efruxifermin on a liver condition known as Nonalcoholic Steatohepatitis (NASH) or Metabolic Dysfunction-Associated Steatohepatitis (MASH). These conditions are types of liver disease that occur when fat builds up in the liver, leading to inflammation and damage. The study aims to evaluate how well Efruxifermin works in people with a specific stage of liver disease called compensated cirrhosis, which means the liver is scarred but still able to perform its functions.

Participants in the study will receive either Efruxifermin or a placebo, which is a substance with no active medication. The treatment is given as a solution for injection under the skin. The study will monitor participants over a period to see if Efruxifermin can improve liver health by reducing scarring and preventing the disease from getting worse. The main goal is to see if the treatment can help people live longer without experiencing serious liver-related problems.

The study will last for several years, with regular check-ups to assess the health of the liver and overall well-being of the participants. The researchers will look at various health markers, including liver function tests and other indicators of liver health, to determine the effectiveness of Efruxifermin compared to the placebo. This research is important for understanding how to better treat liver diseases like NASH and MASH and improve the quality of life for those affected.

1 joining the study

Upon joining the study, participants will be randomly assigned to receive either the investigational medication efruxifermin or a placebo. A placebo is a substance with no active medication, used to compare the effects of the investigational drug.

The study is double-blind, meaning neither the participants nor the researchers know who is receiving the investigational medication or the placebo.

2 medication administration

Participants will receive the medication as a solution for injection under the skin, known as a subcutaneous injection.

The dosage and frequency of the injections will be determined by the study protocol and communicated to participants by the study team.

3 regular check-ups

Participants will attend regular check-ups to monitor their health and the effects of the medication. These check-ups will include physical examinations, blood tests, and other necessary assessments.

The study team will provide specific instructions on when and where these check-ups will take place.

4 monitoring and reporting

Participants are required to report any side effects or changes in their health to the study team immediately. This is crucial for ensuring participant safety and the integrity of the study.

The study team will provide contact information and instructions on how to report any issues.

5 end of study participation

At the end of the study, participants will undergo a final evaluation to assess their health and the effects of the medication.

Participants will be informed about the results of the study and any further steps if necessary.

Who Can Join the Study?

Must be a male or non-pregnant, non-lactating female between 18-80 years old.
Must be willing and able to give written informed consent before any study procedures.
If female and capable of having children, must have a negative pregnancy test at the start of the study.
If capable of having children and engaging in heterosexual intercourse, must agree to use specified methods of contraception.
Must have a history or presence of type 2 diabetes or at least two of the following: obesity, abnormal cholesterol levels (dyslipidemia), high blood pressure, or high fasting blood sugar.
Must have a body mass index (BMI) of 25 or higher. BMI is a measure of body fat based on height and weight.
For certain participants, must have a FibroScan® test or ELF score to assess liver stiffness.
For certain participants, must have a biopsy-proven compensated cirrhosis due to NASH/MASH, with specific scores on a liver biopsy.
Must have specific laboratory test results within certain ranges, such as albumin, kidney function, blood sugar levels, and others.
Must have stable liver enzyme levels (ALT and AST) without significant worsening before the study starts.

Who Cannot Join the Study?

Patients with other serious liver diseases cannot participate.
Patients who have had a liver transplant are not eligible.
Patients with uncontrolled diabetes, which means their blood sugar levels are not stable, cannot join the study.
Patients with a history of significant alcohol or drug abuse in the past year are excluded.
Patients with certain heart conditions, such as heart failure or recent heart attack, cannot participate.
Patients with active cancer, except for some skin cancers, are not eligible.
Patients who are pregnant or breastfeeding cannot join the study.
Patients who are participating in another clinical trial are excluded.
Patients with severe kidney disease are not eligible.
Patients with certain infections, like hepatitis B or C, are excluded.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Medizinische Hochschule Hannover	Hanover	Germany
Centre Hospitalier Universitaire De Lille	Lille	France
Universitaet Leipzig	Leipzig	Germany
IRCCS Humanitas Research Hospital	Rozzano	Italy
Futuremeds Sp. z o.o.	Wroclaw	Poland
Oncopole Claudius Regaud	Toulouse	France
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Centre Hospitalier De Versailles	Le Chesnay-Rocquencourt	France
Casa Sollievo Della Sofferenza	San Giovanni Rotondo	Italy
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hopital Beaujon	Clichy	France
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
ARNAS Garibaldi Di Catania	Catania	Italy
Eugastro GmbH	Leipzig	Germany
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Synexus Polska Sp. z o.o.	Poznan	Poland
Hopital Saint Joseph	Marseille	France
Azienda Ospedaliero-Universitaria Maggiore Della Carita	Novara	Italy
A.O.U. Policlinico G. Martino Di Messina	Messina	Italy
Virgen del Rocío University Hospital	Sevilla	Spain
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Saarland University Hospital	Homburg	Germany
Centre Hospitalier Universitaire De Nice	Nice	France
Hqdwjlbx Uyjqbfpnzajcl Mrmxzrs Du Vcuhocwbna	Santander	Spain
Pnre Tfqcp Hqhcfcfr Uhuqhnpnwivw	Sabadell	Spain
Aspljjo Odetqbibwhl Udpannwlqdsbd Csfieubxpqcq Dbecn Snvjwx E Damxu Suxeifg Dy Tvpmzm	Turin	Italy
Csml Dh Necni	Vandoeuvre Les Nancy	France
Akcgyhv Oblsrnzguts Uvmxpyvuzkgxm Ofrqacty Rzaagcl	Foggia	Italy
Gjmiys Uwyomoharj Fuairxlzv	Frankfurt	Germany
Cjkdwq Hyfctxugdfa Ea Uoxebqtghuvwy Dq Lmeatvf	Limoges	France
Auokdyl Uihwf Szaevyjcn Ldvscx Di Bfdlnwz	Bologna	Italy
Cfffnw Hgntvkxudtv Rdokxqcp Dypngjobmuhtfl	Angers	France
Uxaksehjdrumwradkhpgr Wwrbyztaf Acg	Wuerzburg	Germany
Cwc Crssy Rfcttpzvcfs	Lyon	France
Hkachgqo Vvaf drvhqlim	Barcelona	Spain
Hwyqcdqz Uvneuazxdfjyve Sllskarqel &uuspae Hrzluan dt Hwfkvxozybm	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	21.10.2024
Germany	Recruiting	21.10.2024
Italy	Recruiting	21.10.2024
Poland	Recruiting	21.10.2024
Spain	Recruiting	21.10.2024

Trial locations

Investigated drugs:

Efruxifermin

Efruxifermin is a medication being studied for its potential to help people with a liver condition called nonalcoholic steatohepatitis (NASH) or metabolic dysfunction-associated steatohepatitis (MASH). These conditions can lead to a serious liver problem known as cirrhosis, where the liver becomes scarred and doesn’t work as well as it should. Efruxifermin is being tested to see if it can improve liver health by reducing the scarring and improving liver function. The goal is to see if this medication can help people live longer and have better liver health by preventing or reducing the damage caused by these liver conditions.

Non-Alcoholic Steatohepatitis (NASH) – Non-Alcoholic Steatohepatitis is a liver disease characterized by the accumulation of fat in the liver, inflammation, and liver cell damage. It is part of a group of conditions known as non-alcoholic fatty liver disease (NAFLD). NASH progresses from simple fatty liver (steatosis) to more severe liver damage. Over time, the inflammation and liver cell damage can lead to fibrosis, which is the formation of scar tissue in the liver. If fibrosis continues to progress, it can result in cirrhosis, where the liver becomes severely scarred and its function is impaired. NASH is often associated with obesity, insulin resistance, and metabolic syndrome.

Metabolic Dysfunction-Associated Steatohepatitis (MASH) – Metabolic Dysfunction-Associated Steatohepatitis is a liver condition similar to Non-Alcoholic Steatohepatitis, characterized by fat accumulation, inflammation, and liver cell damage. It is associated with metabolic dysfunctions such as obesity, type 2 diabetes, and dyslipidemia. MASH progresses from simple steatosis to more severe liver damage, including inflammation and fibrosis. The ongoing liver damage can lead to the development of cirrhosis, where the liver becomes heavily scarred. This condition is part of a broader spectrum of liver diseases linked to metabolic syndrome. MASH highlights the role of metabolic dysfunction in the progression of liver disease.

Trial ID:

2024-512895-36-00

Protocol code:

AK-US-001-0106

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on Efruxifermin for Patients with Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) or Metabolic Dysfunction-Associated Steatohepatitis (MASH)

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?