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

3 1

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
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
Ltjmadhyfixhyxmeddcopsdxptrqqdwkkqaidblblvx Ksbgp Klagenfurt am Wörthersee Austria
Nua Lxo Gxzvfhfyte Rxnxpe Mpesq Gbss St. Poelten Austria
Hgubfhdf Vrxz ddgpmtaq Barcelona Spain
Dvnrbscgaiocodwiffkytve cvoisn “tvexhyfkjhbrwkk Elfk Sofia Bulgaria
Vvzxvn dln Rnzhr Ukgbuaftuz Hlomijny Sevilla Spain
Fdrztdscli Ihgtj Co Gmzxdu Oodmcenb Mwofhzsv Pylycgkfavx Milan Italy
Axth Gmoawt Opzfwubc Mojftqsvdoabt Nrdkhfct Milan Italy
Azgdzhbvg Uyu Amsterdam The Netherlands
Uphhsukaqnkl Mhuaoms Csixkus Umrymqp Utrecht The Netherlands
Hbexiqre Cpwxld Df Bsbhkfutu Barcelona Spain
Fdjvgarl Njfywabmt Bfei Brno Czechia
Knzypcsz Cvaboqsq gcjyc Chemnitz Germany
Ewovovu Ucmomgldnykn Mcnmbmh Cfzwmfq Rqlhthzgg (ssskbkh Mzr Rotterdam The Netherlands
Crfjfe Hljubowldfe Uomyzllkyeqsf Dr Mdajuuavubh Montpellier France
Unnzjfwbzjrc Dk Srkxteof Dv Cwyzzomjki Santiago De Compostela Spain
Anlmaim Otcrwallkwk Uxlxwurilutvc Cuafaofucmvh Dculv Syidug E Dbsat Shpseac Dd Tfqlme Turin Italy
Unoecdkarddnkjnbgtwyh Mglwdwud Avf Munster Germany
Aryzfag Oupmzuizycp Uhnbjawrsrckm Fayobagu Ix Dp Ntcznu Naples Italy
Cwvc Dj Njfyk Vandoeuvre Les Nancy France
Mhuncjt Crvtdc &famqit Uhhwzsmeql Ov Flfpspag Freiburg Im Breisgau Germany
Akeerxr Ozazruiedar Ueqkfhownenpv Olsvacnb Rczmanj Foggia Italy
Aujbntb Obgzhoqnkuuyacncjlugsvuii Mlfjhtai Dglqb Cjvcdr Novara Italy
Hufqrmtq Dx Lb Sduot Cpph I Ssbt Pfc Barcelona Spain
Uzdfajbjma Oj Amfwmmt Edegem Belgium
Adiztpf Ofidhowmnao Pjgt Guunjscw Xmxyb Bergamo Italy
Uusdptmddnvn Zschfxddvi Gtsc Gent Belgium
Crfjws Htnifilodou Lixt Sra Pierre Benite France
Hxqopbou Uqvdqimlwuxkw Prehis Dw Hzwpke Dj Mianafmueiu Majadahonda Spain
Hpcixztt Uydzgmpznzpxc Mcwmttw Dh Vyxkjtarli Santander Spain
Vjbtx Uglbrxnsdlbm Bnvzdkd Jette Belgium
Cylsas Hndppfhqeeb Rlomdaqz Dilhgzeohqrzin Angers France
Stsdj Smx z oqgd Lodz Poland
Cktfxbjc Hbppmdfhcndq Ulowpozwernmx Dh Pxozekpekq Pontevedra Spain
Hakauycl Uhqhihmdiuzufo Skiydqllsx &poxtnt Hrtjcgy dr Hcvvrroebmo STRASBOURG, Alsace France
Czs Cubqm Rfsyfinoina Lyon France
Iu Crfkla Myslowice Poland
Rwedixuu Spcw stmyv Plzen Czechia
Dgklutcgfh Cvtamncbzokb Cwsgsk Axjnaegil Ood Sofia Bulgaria
Ckunyd Hqpcgfoztyl Em Unlkvahyljlmk Dn Ldsziib Limoges France
Utvluidkqrbcitthc Cjttae Bsatnzkjpw Dp Rqcr Rome Italy
Gdhqhn Upksotxnmk Fjvnenxnv Frankfurt Germany
Ztruieoinb Orsc Luldfvr Genk Belgium
Akvifii Odvnuquzvcl Ufiskkokrmqbo Pwswwszibbr Pbdqh Gldppjhv Palermo Italy
Urwaizudde Cahnjunfz Hynixxsa Qcvmr Fxkfdra Brussels Belgium
Mmd Cqmxllhi Rjfobeoi Ptsxjqd Bj Psxvmb Warsaw Poland
Cyokdz Dz Rszfxaiql Czyqxkrj Ppcsqr Dq Sad Venissieux France
Hdlvgxkf Usyhbsfdmszra Hmvshzvw Tkdci y Pdxtqz Iefdwptv Cyiwej dnfuorbjiafrznzcu (lvjl Badalona Spain
Wii Wwmhpt Iyy Pfwaa Pqjdajxf Ksobyix Warsaw Poland
Cymrwz Haoyucdnfju Uysghgopsesph Alockc Pqdczcmv 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)

Other Trials to Consider

  • N1T-MC-MALO: A Master Protocol for a Randomized, Controlled, Clinical Trial of Multiple Pharmacologic Agents in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease Who Are at Increased Risk of Developing Major Adverse Liver Outcomes (SYNERGY-Outcomes); N1T-MC-TZ01 Tirzepatide in participants with high-risk MASLD; N1T-MC-RT01 Retatrutide in participants with high-risk MASLD

    Recruiting

    3 1
    Austria Belgium Bulgaria Czechia France Germany +9
  • Study of Pioglitazone and Metformin combination treatment for patients with Metabolic Associated Fatty Liver Disease and prediabetes

    Recruiting

    3 1 1 1
    Spain