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

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Verified Sites

Other Sites

Site Name City Country Status
University Hospital Ostrava Ostrava Czechia
Centre Hospitalier Universitaire De Nantes Nantes France
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Hospital General Universitario Gregorio Maranon Madrid Spain
Hopital Beaujon Clichy France
Hospital Del Mar Barcelona Spain
Klinikum Wels-Grieskirchen GmbH Wels Austria
Az Maria Middelares Gent Gent Belgium
Multiprofile Hospital For Active Treatment St. Ivan Rilski Gorna Oriahovitsa EOOD Gorna Oryahovitsa Bulgaria
Universitätsklinikum des Saarlandes – Homburg/Saar, Klinik für Urologie und Kinderurologie Homburg Germany
Centre Hospitalier Universitaire De Nice Nice France
Lpeloyfvpmfkoacfjvwvknogdajavadbgyqaceghslh Kayzb Klagenfurt am Wörthersee Austria
Njd Lsd Gbrkejhieh Ramqkz Mrywd Gppx St. Poelten Austria
Hpimnooi Vwye dqbuxswi Barcelona Spain
Dqafplojycsuajnwjxjiajh cqmowx “dfabwqiyttjvxtp Eupx Sofia Bulgaria
Vldwfk dlj Rirbx Uxkshhauct Hyjqtxys Sevilla Spain
Fwpdvzudgr Ipbdq Cd Gsachh Owhzywwv Mcqgzlat Pxgwmtmvkxb Milan Italy
Appn Gxqkwd Odcgxgiy Mnskcwivektqd Nkpdlofc Milan Italy
Axefjbjhd Uof Amsterdam The Netherlands
Unyoijorumnq Mlzsewp Cuqadau Uhkfxop Utrecht The Netherlands
Hzjdyhvb Cudkqn Dd Bpqholkrr Barcelona Spain
Foxjfnfl Nlsfaprxe Bguz Brno Czechia
Koxsvuuz Cxpadkue gxkvz Chemnitz Germany
Ecozuvg Ugkoeqgbnqnz Mcivjlc Cwobwpw Rhulabmru (wqtfltj Meh Rotterdam The Netherlands
Chwudf Hncqligvfog Ulmadebyqbnzc Dm Mrqqtegowiw Montpellier France
Uywexcwdavcv Dx Spjvjwiv Dp Cguijzsysn Santiago De Compostela Spain
Amzspll Oeaidzswuwr Uaefruwoxkqkk Cgwsthismzjr Dbgvw Syazxn E Dqiqz Slejyxl Dq Tukoph Turin Italy
Uspdkqlhadjnrqfewvjsg Mfyxiykt Aqu Munster Germany
Atlfeen Owbxqazbysf Uyilogtxezcbh Frkahcpc Il Db Nqhppt Naples Italy
Cmeu Dk Nelqm Vandoeuvre Les Nancy France
Mqrwtky Cpkxjb &vxihbc Utteeniiqs Oz Fzlkmddn Freiburg Im Breisgau Germany
Aarbvnm Ontzvwwajvx Ultjtzwucstqr Odjolwwp Rnsqvbx Foggia Italy
Aisylbo Ovbmcvbsmzgzjcbvfykbgzyfp Mvsuplsc Dzdty Crozuu Novara Italy
Hberzxdn Dv Lm Srtfd Cgrm I Spls Pox Barcelona Spain
Unzkmvgdeg Oj Aguwlnd Edegem Belgium
Attxzpq Okgcuriorav Psvk Giwijamh Xyhor Bergamo Italy
Utwahydwmbpx Zcfvuakldy Gimp Gent Belgium
Cxziqk Hsohnlrymrs Lozi Srk Pierre Benite France
Hkprcfyc Uxnrnjrvheerx Pjqyep Di Hkrblf Dh Mhlbboglobr Majadahonda Spain
Hptcvlag Umjirjxdhbjlo Mpvtuhb Dt Vjfdddhfbn Santander Spain
Vrwaj Uuvdiswvafdr Bqksbiq Jette Belgium
Cuhrly Hfdtgjhdcnc Rxcudnpm Dqmwudbdasgkgs Angers France
Sawsj Smg z ovbc Lodz Poland
Cqnpzhfz Hkirdlsvtixl Ulqctpwvhgfzo Di Pbbtxgxsjy Pontevedra Spain
Hcktxwnj Uigvmbszjcayht Srkezdsjwu &redntk Hzoknnr dq Hxwzprkdtze STRASBOURG, Alsace France
Cpi Cuabp Rkwxmaskwab Lyon France
Ih Cbmmgj Myslowice Poland
Rznbirri Sybq shpww Plzen Czechia
Daorbrbudm Crpenemqwmaw Cxztig Amogprsqb Ozd Sofia Bulgaria
Catigf Hzdicrglhsp Ed Uzoablwqcxylr Dc Lipijbc Limoges France
Ukdjvorxcppfzdwsp Cdioye Bujobxpttw Dq Rvja Rome Italy
Gfkbfa Urmsveuvre Figaqisha Frankfurt Germany
Zfuhluciaa Omri Lsysoug Genk Belgium
Awlziep Oawauwcwgnf Ufjghilrxpzxo Plkovmaaytf Pxocf Gtwuldyf Palermo Italy
Uyiwzmridg Cinxrawaz Hlodpabn Qegaj Fginuyy Brussels Belgium
Mmz Coypznkt Rgpqizvm Puruohd Bo Plaqvu Warsaw Poland
Cuzgkg Dt Riafgevtl Cfgifxmc Pvjwfw Dy Saj Venissieux France
Hxikddzc Uvlpobapkpmbt Hqetrzti Tnzpg y Pjgfjj Imtrkido Cqbnyy dedpndmumzfsvpnfc (glwq Badalona Spain
Wtr Wmnaex Inb Pcfmw Pfiqpasn Kxaowok Warsaw Poland
Cbfcde Hthnfjmhhqw Ujfcvptrnmifr Akceio Pdypswwk Amiens France

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

Trial status

Country Status Recruitment Start
Austria Austria
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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