Study on Efruxifermin for Patients with Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH) and Fibrosis

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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 Non-Alcoholic Steatohepatitis (NASH) and its related condition, Metabolic Dysfunction-Associated Steatohepatitis (MASH). These conditions involve the buildup of fat in the liver, which can lead to liver damage and scarring, known as fibrosis. The study aims to see if Efruxifermin can help improve these liver conditions by reducing liver fat and scarring.

Participants in the study will receive either Efruxifermin or a placebo, which is a substance with no active medication. Efruxifermin is given as a solution for injection, meaning it is administered through a needle under the skin. The study will last for about 52 weeks, during which participants will have regular check-ups to monitor their liver health and overall well-being. The main goal is to see if Efruxifermin can help resolve NASH/MASH and reduce fibrosis by the end of the study period.

The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving Efruxifermin and who is receiving the placebo. This helps ensure that the results are unbiased. The trial will also evaluate the safety of Efruxifermin, looking at any side effects that may occur. By the end of the study, researchers hope to determine if Efruxifermin is an effective treatment option for people with NASH/MASH and fibrosis.

1 joining the study

Upon joining the study, participants are randomly assigned to receive either the medication efruxifermin or a placebo. This process is double-blind, meaning neither the participant nor the researchers know which treatment is being administered.

2 medication administration

Participants receive efruxifermin as a solution for injection. The medication is administered subcutaneously, which means it is injected under the skin. The frequency and dosage are determined by the study protocol and are consistent throughout the trial.

3 monitoring and assessments

Throughout the study, participants undergo regular monitoring and assessments to evaluate the safety and effectiveness of the treatment. This includes measuring liver function, cholesterol levels, and other health indicators.

4 primary evaluation at week 52

At week 52, the primary evaluation occurs. The main goal is to determine if there is a resolution of NASH/MASH and improvement in liver fibrosis. This is assessed through various clinical tests and measurements.

5 secondary evaluation at week 96

A secondary evaluation is conducted at week 96 to further assess the long-term effects of the treatment. This includes checking for continued resolution of NASH/MASH and any changes in liver fibrosis.

6 completion of the study

The study is estimated to conclude by January 2027. Participants will have contributed valuable data to understand the treatment’s impact on NASH/MASH and liver fibrosis.

Who Can Join the Study?

Participants must be males or non-pregnant, non-lactating females aged between 18 and 80 years old.
Females who can have children must have a negative pregnancy test before starting the study.
Participants who can have children and are sexually active must agree to use specific contraception methods during the study.
Participants should have a history or presence of Type 2 Diabetes (T2D) or meet at least two of the following conditions: obesity, dyslipidemia (abnormal cholesterol levels), high blood pressure, or high fasting blood sugar.
Participants must have a Body Mass Index (BMI) of 25 or higher. BMI is a measure of body fat based on height and weight.
If participants do not have a previous liver biopsy that meets certain criteria, they must have either a FibroScan® liver stiffness measurement greater than 7.5 kPa or an Enhanced Liver Fibrosis (ELF) score of 7.7 or higher.
Participants must have specific laboratory test results within certain ranges, including kidney function, blood sugar levels, blood clotting, liver function, and vitamin D levels.
Participants must have stable levels of certain liver enzymes, ALT and AST, which are indicators of liver health.
Participants must have a biopsy-proven diagnosis of NASH/MASH with specific liver conditions, including fibrosis stage 2 or 3 and a certain score on the NAFLD activity score.
Participants must follow guidelines for any medications they are taking, ensuring they are on a stable dose.
Participants must be willing and able to provide written informed consent before any study procedures begin.

Who Cannot Join the Study?

Patients who have other liver diseases not related to MASH or NASH.
Patients who have a history of significant alcohol consumption, as this can affect the liver.
Patients who have other serious health conditions that might interfere with the study.
Patients who are pregnant or breastfeeding, as the effects on the baby are unknown.
Patients who are currently participating in another clinical trial, to avoid interference with results.
Patients who have had a liver transplant, as this can affect the study outcomes.
Patients who have a known allergy to the study medication or its ingredients.
Patients who are unable to follow the study procedures or attend the required visits.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Futuremeds Sp. z o.o.	Wroclaw	Poland
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
IRCCS Humanitas Research Hospital	Rozzano	Italy
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Universitaet Leipzig	Leipzig	Germany
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Krakowskie Centrum Medyczne Sp. z o.o.	Cracow	Poland

Other Sites

Site Name	City	Country
Synexus Polska Sp. z o.o.	Wroclaw	Poland
Centre Hospitalier De Versailles	Le Chesnay-Rocquencourt	France
Synexus Polska Sp. z o.o.	Poznan	Poland
Hopital Saint Joseph	Marseille	France
Centre Hospitalier Universitaire De Nice	Nice	France
Epimed Gesellschaft fuer epidemiologische und klinische Forschung in der Medizin mbH	Berlin	Germany
Azienda Ospedaliero-Universitaria Maggiore Della Carita	Novara	Italy
Synexus Polska Sp. z o.o.	Warsaw	Poland
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Hopitaux Universitaires Pitie Salpetriere	Paris	France
Virgen del Rocío University Hospital	Sevilla	Spain
Velocity Clinical Research Leipzig GmbH	Leipzig	Germany
Les Hopitaux Universitaires De Strasbourg	STRASBOURG, Alsace	France
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Centre Hospitalier Universitaire De Toulouse	Toulouse	France
Saarland University Hospital	Homburg	Germany
Universita’ Di Pisa	Pisa	Italy
Pratia S.A.	Skorzewo	Poland
A.O.U. Policlinico G. Martino Di Messina	Messina	Italy
Casa Sollievo Della Sofferenza	San Giovanni Rotondo	Italy
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Deutsches Herzzentrum Berlin	Berlin	Germany
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hopital Beaujon	Clichy	France
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Eugastro GmbH	Leipzig	Germany
Hopital Saint Eloi	Montpellier	France
Pxly Twqlw Haxfqyyi Upsjiafqhygn	Sabadell	Spain
Slvacur Pqmowj Sba z oumt	Gdansk	Poland
Cqgs Dr Nptjl	Vandoeuvre Les Nancy	France
Anurfgf Ostqibqzrwj Uihofybcvqcog Oycxsgit Rdgthnl	Foggia	Italy
Soynfno Psnkbn Sbm z oqcw	Gdynia	Poland
Syajyhs Pudblo Sbf z ozzs	Czestochowa	Poland
Snqbrtd Pzpkyi Sfp z owdu Oapoysa w Kkierbrrtb	Katowice	Poland
Cgviwh Hymobocdgea Ez Ulsjrjaimnzxr Dw Lvrngwn	Limoges	France
Apmfylm Oxucmagdcle Uyxbnyraomfwq Crujqgzzrbup Dcqiw Svpkww E Dmrry Sgsqlmz Dl Tpkfdo	Turin	Italy
Grqnia Udzexghpye Fajarxbao	Frankfurt	Germany
Umntfrxpsjjlrubjzeimv Weczptkig Ayp	Wuerzburg	Germany
Abqjtbh Ueaya Syrtwlmnl Ltqlvc Dm Bpmgepl	Bologna	Italy
Hrtvhmtc Uweincbggpqdh Mquymen Dm Vkkduemlpv	Santander	Spain
Cmekyi Huuymojupcw Rynczxqb Dxauagctbphirm	Angers	France
Hlfctfve Vjnu djmbibem	Barcelona	Spain
Cfu Cwsta Rrzwblqddpa	Lyon	France
Wpj Wzcixg Iyu Pbmhx Pcxolbka Klidplh	Warsaw	Poland

Trial status

Country	Status	Recruitment Start
France	Recruiting	24.01.2024
Germany	Recruiting	24.01.2024
Italy	Recruiting	24.01.2024
Poland	Recruiting	24.01.2024
Spain	Recruiting	24.01.2024

Trial locations

Investigated drugs:

Efruxifermin

Efruxifermin is a medication being studied for its potential to treat a liver condition known as non-cirrhotic nonalcoholic steatohepatitis (NASH) or metabolic dysfunction-associated steatohepatitis (MASH). This condition involves inflammation and damage in the liver, often associated with fat buildup, but not caused by alcohol. Efruxifermin is being tested to see if it can help reduce liver inflammation and improve liver health by resolving the condition and reducing liver fibrosis, which is the thickening and scarring of liver tissue.

Investigated diseases:

Hepatic fibrosis

Metabolic Dysfunction-Associated Steatohepatitis (MASH) – This condition is characterized by the accumulation of fat in the liver, accompanied by inflammation and liver cell damage. It is associated with metabolic dysfunctions such as obesity, insulin resistance, and dyslipidemia. Over time, MASH can lead to liver fibrosis, where scar tissue forms in the liver. The progression of the disease can vary, with some individuals experiencing a slow progression while others may see more rapid changes. The liver inflammation and damage can potentially lead to more severe liver conditions if not managed.

Non-Alcoholic Steatohepatitis (NASH) – NASH is a liver disease that occurs when fat builds up in the liver, causing inflammation and damage to liver cells. Unlike alcoholic liver disease, NASH occurs in individuals who consume little to no alcohol. The disease can progress to liver fibrosis, where scar tissue replaces healthy liver tissue. Over time, this can lead to cirrhosis, a more severe form of liver damage. The progression of NASH can vary widely among individuals, with some experiencing minimal symptoms while others may develop significant liver damage.

Fibrosis – Fibrosis is a condition characterized by the excessive formation of scar tissue in an organ, often as a result of chronic inflammation or injury. In the liver, fibrosis occurs when the normal tissue is replaced by scar tissue, which can impair liver function. The progression of fibrosis can lead to cirrhosis, where the liver becomes severely scarred and its function is compromised. Fibrosis can occur in various organs, but in the context of liver diseases like NASH and MASH, it is a critical factor in disease progression. The extent and rate of fibrosis progression can vary, influencing the overall health and function of the affected organ.

Trial ID:

2023-505141-48-00

Protocol code:

AK-US-001-0105

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Efruxifermin for Patients with Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH) and Fibrosis

What is this study about?

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