Study on the Effects of Pegozafermin for Patients with Nonalcoholic Steatohepatitis (NASH) and Fibrosis

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What is this study about?

This clinical trial is focused on studying a liver condition known as Metabolic Dysfunction-Associated Steatohepatitis (MASH), which is also referred to as Nonalcoholic Steatohepatitis (NASH) with fibrosis. This condition involves the buildup of fat in the liver, leading to inflammation and scarring, which can affect liver function. The study will evaluate a treatment called Pegozafermin, which is administered as a solution for injection. Pegozafermin is being compared to a placebo to assess its effectiveness and safety in treating this liver condition.

The purpose of the study is to determine how well Pegozafermin works in improving liver health and reducing the risk of further liver damage. Participants in the study will receive either Pegozafermin or a placebo through a pre-filled syringe, which is injected under the skin. The study will last for a period of up to 36 months, with key assessments taking place at 52 weeks and at the end of the study. During this time, the effects of the treatment on liver health will be closely monitored.

Throughout the study, participants will undergo various assessments, including imaging tests like Magnetic Resonance Imaging (MRI), to measure changes in liver fat and other liver-related health markers. The study aims to provide valuable insights into the potential benefits of Pegozafermin for individuals with MASH/NASH and fibrosis, ultimately contributing to better treatment options for this condition.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, liver condition, and body mass index (BMI).

Participants must have a biopsy-confirmed diagnosis of metabolic dysfunction-associated steatohepatitis (MASH) with fibrosis.

2 initial assessment

An initial assessment is conducted to establish baseline health metrics. This includes a liver biopsy to evaluate the current state of liver health.

3 treatment administration

Participants receive either pegozafermin or a placebo. The medication is administered as a solution for injection under the skin (subcutaneous use).

The treatment period lasts for 52 weeks, during which the effect on liver health is monitored.

4 ongoing monitoring

Throughout the study, regular check-ups are conducted to monitor liver health and overall well-being.

Liver fat content is assessed using magnetic resonance imaging (MRI) at week 52.

5 final assessment

At the end of the 52-week treatment period, a final assessment is conducted to evaluate changes in liver fibrosis and overall liver health.

The study aims to determine if there is an improvement in liver fibrosis and resolution of MASH without worsening the condition.

6 long-term follow-up

Participants are monitored for up to 36 months to assess long-term outcomes and any progression of the disease.

Changes in liver enzymes and the occurrence of any clinical events are recorded during this period.

Who Can Join the Study?

  • Must be a male or a non-pregnant female aged between 18 and 75 years old at the time of signing the informed consent form.
  • Must have a liver biopsy that confirms Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) with fibrosis stage F2 or F3. Fibrosis is a condition where the liver becomes scarred. The biopsy must show a NAS (a score used to measure liver damage) of 4 or more, with at least 1 point in each of the following: steatosis (fat in the liver), ballooning degeneration (swelling of liver cells), and lobular inflammation (inflammation in the liver).
  • Must have a Body Mass Index (BMI) of 25.0 or more (23.0 or more for Asian participants) and less than 50.0 kg/m². BMI is a measure that uses height and weight to estimate body fat.

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Noe LGA Gesundheit Region Mitte GmbH St. Poelten Austria
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Universitair Ziekenhuis Gent Gent Belgium
Centre Hospitalier Lyon Sud Pierre Benite France
Hospital General Universitario Gregorio Maranon Madrid Spain
Hopital Beaujon Clichy France
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Del Mar Barcelona Spain
Klinikum Wels-Grieskirchen GmbH Wels Austria
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo Italy
Az Maria Middelares Gent Gent Belgium
Mtz Clinical Research Powered By Pratia Warsaw Poland
Santa Sp. z o.o. Lodz Poland
Complexo Hospitalario Universitario De Pontevedra Pontevedra Spain
Umbal – Prof. D-R Stoyan Kirkovich AD Stara Zagora Bulgaria
Multiprofile Hospital For Active Treatment St. Ivan Rilski Gorna Oriahovitsa EOOD Gorna Oryahovitsa Bulgaria
Centre De Recherche Clinique Portes Du Sud Venissieux France
Landeskrankenanstalten-Betriebsgesellschaft Kabeg Klagenfurt am Wörthersee Austria
ID Clinic Myslowice Poland
RESEARCH SITE s.r.o Plzen Czechia
Diagnostic Consultative Centre Ascendent OOD Sofia Bulgaria
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
Virgen del Rocío University Hospital Sevilla Spain
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Universita’ Campus Bio-medico Di Roma Rome Italy
Hospital Clinic De Barcelona Barcelona Spain
Fakultni Nemocnice Brno Brno Czechia
Saarland University Hospital Homburg Germany
Klinikum Chemnitz gGmbH Chemnitz Germany
Centre Hospitalier Universitaire De Montpellier Montpellier France
Universidade De Santiago De Compostela Santiago De Compostela Spain
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Nice Nice France
Azienda Ospedaliero-Universitaria Maggiore Della Carita Novara Italy
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Ziekenhuis Oost Limburg Genk Belgium
Vrije Universiteit Brussel Jette Belgium
University Childrens Hospital Queen Fabiola Brussels Belgium
University Hospital Ostrava Ostrava Czechia
Hdxgkbox Ujtmmgsxgvcmp Mjpylwn Dj Vcuyjoeebe Santander Spain
Ctupbj Huccgggzafc Er Ungkdwkqfpqsq Dc Ljazqfj Limoges France
Abnpmouar Uih Amsterdam The Netherlands
Esjbmrp Uphvdoljqusd Mqzotka Cwaylja Rgdcxhfqu (jmstrpu Mcb Rotterdam The Netherlands
Akhlwlq Ocjympqgdsh Uvjluqsdqvfjq Crxrgdhoymos Dxwdi Swadfc E Doplc Swcbaak Dz Tvisgp Turin Italy
Uwqmvkfxgrwdobwgzvjrq Mnlufwwx Ate Munster Germany
Coxy Dy Nxwpd Vandoeuvre Les Nancy France
Axfdblz Oirrvauvqys Ujrepkhxnurek Oalmtvff Rlvaame Foggia Italy
Gfsbxs Urgnyymzgt Fkmdwcsxx Frankfurt Germany
Hlfwgbqa Dw Ly Ssimh Cgjj I Svfo Ppk Barcelona Spain
Ubodzljjbw Ow Aiswgmo Edegem Belgium
Ayrjzkf Oaxvsyvjdie Pfgh Gtrsogcy Xacka Bergamo Italy
Cwlafw Hcvdyecjpdm Rnktfqdk Dzzsysrzjsinop Angers France
Hquihfzg Uraxubgpyrmpv Hstmawpp Thlii y Ptmluf Ikxrbwid Ctjdgs dstrsdimspfnywqcs (dudw Badalona Spain
Cop Ctwxl Rvcharncfns Lyon France
Haauvisx Vzxr dlnmhbik Barcelona Spain
Wcb Wdhlil Ifc Pfhly Polnryvp Kmunobp Warsaw Poland
Hbxqojxn Uktrpjpshjcbtg Smwsnrufps &affhes Hgrqukp db Hvyglpnvksw STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not yet recruiting
01.09.2024
Belgium Belgium
Recruiting
01.09.2024
Bulgaria Bulgaria
Recruiting
01.09.2024
Czechia Czechia
Recruiting
01.09.2024
France France
Recruiting
01.09.2024
Germany Germany
Recruiting
01.09.2024
Italy Italy
Recruiting
01.09.2024
Poland Poland
Recruiting
01.09.2024
Spain Spain
Recruiting
01.09.2024
The Netherlands The Netherlands
Recruiting
01.09.2024

Trial locations

Investigated drugs:

Pegozafermin is a medication being studied for its potential to improve liver health in people with a condition called Metabolic Dysfunction-Associated Steatohepatitis (MASH) and fibrosis. The trial aims to see if pegozafermin can help improve liver tissue health over a period of 52 weeks and reduce the risk of negative health outcomes related to this liver condition.

Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis – This disease involves the accumulation of fat in the liver not due to alcohol consumption, leading to liver inflammation and damage. Over time, the inflammation can cause scarring, known as fibrosis, which can impair liver function. MASH/NASH is often associated with metabolic conditions such as obesity, diabetes, and high cholesterol. The disease progresses as liver cells are damaged and replaced by scar tissue, which can eventually lead to more severe liver conditions. Symptoms may not be noticeable in the early stages, but as the disease progresses, individuals may experience fatigue, weakness, and abdominal discomfort. The progression of fibrosis is a key concern, as it can lead to significant liver impairment.

Trial ID:
2023-509912-27-00
Protocol code:
BIO89-100-131
NCT ID:
NCT06318169
Trial Phase:
Therapeutic confirmatory (Phase III)

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