Study on the Effects of Semaglutide in Patients with Non-Alcoholic Steatohepatitis (NASH) and Fibrosis Stages 2 or 3

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What is this study about?

This clinical trial is focused on studying the effects of a medication called semaglutide in people with a liver condition known as non-alcoholic steatohepatitis (NASH). NASH is a type of liver disease that occurs when fat builds up in the liver, leading to inflammation and damage. The study aims to see if semaglutide can improve liver health in people with NASH who have a certain level of liver scarring, known as fibrosis stage 2 or 3.

Participants in the study will receive either semaglutide or a placebo, which is a substance with no active medication. The treatment is given as an injection under the skin using a pre-filled pen. The study is divided into two parts. In the first part, researchers will look at whether semaglutide can improve liver tissue health over a period of 72 weeks. In the second part, they will assess if semaglutide can reduce the risk of liver-related health issues over a longer period of 240 weeks.

The study will monitor various health indicators, including changes in liver tissue, body weight, and other health markers, to determine the effectiveness of semaglutide. Participants will be followed up regularly to track their progress and any changes in their condition. The goal is to gather information on whether semaglutide can be a beneficial treatment for people with NASH, potentially improving their liver health and reducing the risk of further liver damage.

1 joining the study

Upon joining the study, participation begins with a baseline liver biopsy. This biopsy may be a recent one, taken within 180 days before the start of the study.

The biopsy is evaluated by a pathologist to confirm the presence of non-alcoholic steatohepatitis (NASH) and the stage of liver fibrosis.

2 randomization and initial treatment

Participants are randomly assigned to receive either semaglutide or a placebo. Semaglutide is administered as a solution for injection.

The injection is given under the skin (subcutaneous) using a pre-filled pen or syringe.

3 treatment phase part 1

The first part of the treatment phase lasts for 72 weeks. During this time, the effect of semaglutide on liver health is monitored.

The primary goal is to see if semaglutide can resolve steatohepatitis without worsening liver fibrosis.

4 treatment phase part 2

The second part of the treatment phase extends to 240 weeks. The focus is on reducing the risk of liver-related health issues.

Participants continue to receive semaglutide or placebo injections throughout this period.

5 monitoring and assessments

Regular assessments are conducted to monitor changes in liver health, body weight, and other health indicators.

These assessments include liver biopsies, blood tests, and other evaluations to track progress and any side effects.

6 end of study

The study is expected to conclude in April 2029. At the end of the study, final assessments are conducted to evaluate the long-term effects of semaglutide.

The results will help determine the effectiveness of semaglutide in treating NASH and preventing liver-related complications.

Who Can Join the Study?

  • Must be 18 years or older at the time of agreeing to participate in the study.
  • Must have NASH (Non-alcoholic steatohepatitis) confirmed by a liver tissue sample. This sample can be from a test done up to 180 days before the first visit for the study.
  • Must have fibrosis stage 2 or 3. Fibrosis is a type of liver damage, and the stage indicates how severe it is.
  • Must have a NAS score of 4 or more. NAS stands for Nonalcoholic Fatty Liver Disease Activity Score, which measures liver health. The score should include at least 1 point each for fat in the liver, inflammation, and damaged liver cells.
  • Both men and women can participate.

Who Cannot Join the Study?

  • Patients who do not have Non-alcoholic steatohepatitis (NASH) cannot participate. NASH is a liver condition that involves inflammation and damage due to fat buildup in the liver.
  • Patients with liver fibrosis that is not at stage 2 or 3 are excluded. Fibrosis refers to the thickening and scarring of liver tissue.
  • Patients who are not within the specified age range for the study cannot participate. The study includes certain age groups only.
  • Both male and female patients are eligible, but those who do not meet other criteria will be excluded.
  • Patients who are considered part of a vulnerable population are not included in this study. A vulnerable population refers to groups who may have limited ability to give informed consent or are at higher risk of harm.

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
Diagnostic Consultation Center XX-Sofia EOOD Sofia Bulgaria
Hopital Beaujon Clichy France
Az Maria Middelares Gent Gent Belgium
Hospital Clinico Universitario De Valladolid Valladolid Spain
Centrum Badan Klinicznych Piotr Napora Lekarze sp.p. Wroclaw Poland
Unidade Local De Saude Do Alto Minho E.P.E. Viana Do Castelo Portugal
Cpdwtdxfc Ubrjavobeylqki Srjuvnrpz Woluwe-Saint-Lambert Belgium
Lbnlr Gjdpeuu Hyfcypxi Oe Auhedw Athens Greece
Uqxopxjpxu Gubcjeb Hcdsfrca Os Thmzzotnygcm Apsco Thessaloniki Greece
Ufqfobarztg nzywkxpjb Lp Pzthclwl Kssxbq Kosice Slovakia
Hmdtheaj Vvgw daoacbos Barcelona Spain
Bfkhjgtk Hfvkiocc Dublin Ireland
Vuikax dfa Rxojm Uufyxmwjot Hnbycbgx Sevilla Spain
Ooqgfm Uwvbeaxtvk Hypdenfc Odense Denmark
Hqkxim Hxhwdnyk Herlev Denmark
Fcouymjmpn Iygtv Cn Gtjniz Ofzrkmzd Mijaiysi Ptlaaeyacge Milan Italy
Atybtqc Oxzbuejoaov Uwagrpgpqhxce Cdtmivxfmwlv Dazwy Shntuv E Dmuky Ssdroyi Dz Tkujuz Turin Italy
Asrpwsv Ullwc Sgwdgyesl Lflnwb De Bjcyrjs Bologna Italy
Usonvpmenook Zctilwpglr Gysj Gent Belgium
Utsvbphjwkkluekjokyid Sgrtwldwuucbmzcpbo Amm Kiel Germany
Cbxksh Hgmeoxahgyq Luvy Szb Pierre Benite France
Hbozqizm Uoyjitjcjthme Piqqmg Df Hffqjf De Mhgxotvgnjc Majadahonda Spain
Hbylqeoy Uaagkrhxziibu Mlafuwp Db Vbckfiiqvx Santander Spain
Cmcocy Hpgnqlzvkwj Rvbmbhxs Detgiamkxxpjey Angers France
Bsqtgz Szpckqs Gjettum Norway
Czhqsdnt Heusmgfujago Umitysuxqkkwn Dz Pfojhxgnel Pontevedra Spain
Cdqz Cekutl Capiqwc Adcwhswzb Bpgcr Akyswpjmgu Braga Portugal
Iybvtmzrmk Gbfxpib Hxtdevjo Oh Tmcekicurtiw Thessaloniki Greece
Urnbqzmnmqzpszdkhzsak Lspscuj Ato Leipzig Germany
Hyepwyxz Uibrlsftypjuox Soyybhhgjk &wmidly Heroarj dd Hyysdaftpqd STRASBOURG, Alsace France
Iw Cihyjj Myslowice Poland
Rbrhhywr Sufi saaxx Plzen Czechia
Bzgrsdiuit Scs z omtk sessf Warsaw Poland
Kglkwyf nnmgxpgow Lbzltha aegc Liberec Czechia
Uhfiwhrhivoisrltx Cnbdjh Bsvknvjdix Dh Rjlv Rome Italy
Adgqgq Uyuscmcddr Hdxqlbih Aarhus Denmark
Augkvwfok Uzf Amsterdam The Netherlands
Shgepf Jmsmxdfi Di Ukzuknh Sush Mggt Satu Mare Romania
Umzhhmx Lbdqs Dy Skvfa Dg Gkococ Eihyjh Guarda Portugal
Nzfkixqsv Zbaqnuhisyxcgma Sqqeagrnc Alkmaar The Netherlands
Aidr Acfzvmwpsf Puenkmmjny Doo Djvuylarad Dw Pfcxocbg Lisbon Portugal
Hnuqqxit Hhvngxkh Hvidovre Denmark
Kejjty Lwpkvewsarl Vienna Austria
Uyismwz Lwwzv Df Sgyvf Dt Gpksbailhjwa Efrpzx Vila Nova De Gaia Portugal
Arqbrbw Oacmzjqsftd Ucuojaprercfx Pzppoolgzmn Pumrg Gsihgguu Palermo Italy
Utpxexjnml Hypxxlpl Bobfibeuvs Bratislava Slovakia
Uicgwbmcmo Mqiyi Gykekac Oi Cljltffqc Catanzaro Italy
Dyjczn Owmngza Swwvgv Galati Romania
Jof svtxan Trnava Slovakia
Enudcnsc Gzva Leipzig Germany
Uidvdnf Lvcro Da Sicsx Dl Mdwdccfyrl Efzwhz Senhora Da Hora Portugal
Miglrirejrsp spcbdr Petrzalka Slovakia
Cwahwlju Hxkzukml Dtfprep Zagreb Croatia
Hkebvdkb Ckdmlf Df Lumi Lyon France
Ayftnnfqjo Pnluaqnw Hbskbhpo Df Pqnwc Paris France
Cquylf Hrjifvausor Uphziwloscues Dx Nrwz Nice France
Csrihr Hmumsisztx Uynycrljlajdb Di Pskzo Elgifs Porto Portugal
Vgnguueyn Fhivhhsf Nctnedjdr V Pzkjv Prague Czechia

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

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
01.04.2021
Belgium Belgium
Not recruiting
01.04.2021
Bulgaria Bulgaria
Not recruiting
01.04.2021
Croatia Croatia
Not recruiting
01.04.2021
Czechia Czechia
Not recruiting
01.04.2021
Denmark Denmark
Not recruiting
01.04.2021
France France
Not recruiting
01.04.2021
Germany Germany
Not recruiting
01.04.2021
Greece Greece
Not recruiting
01.04.2021
Ireland Ireland
Not recruiting
01.04.2021
Italy Italy
Not recruiting
01.04.2021
Norway Norway
Not recruiting
01.04.2021
Poland Poland
Not recruiting
01.04.2021
Portugal Portugal
Not recruiting
01.04.2021
Romania Romania
Not recruiting
01.04.2021
Slovakia Slovakia
Not recruiting
01.04.2021
Spain Spain
Not recruiting
01.04.2021
The Netherlands The Netherlands
Not recruiting
01.04.2021

Trial locations

Investigated Drugs:

Semaglutide is a medication being studied for its effects on liver health in people with a condition called non-cirrhotic non-alcoholic steatohepatitis (NASH). This condition involves liver inflammation and damage due to fat buildup in the liver, not related to alcohol use. The trial aims to see if semaglutide can improve liver tissue health and reduce the risk of liver-related health issues in patients with NASH and moderate to severe liver fibrosis.

Non-alcoholic steatohepatitis (NASH) – This 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 can progress to more severe liver conditions, such as fibrosis, where scar tissue forms in the liver. Over time, the fibrosis can worsen, leading to cirrhosis, which is a late stage of liver scarring. The disease often develops in individuals who are overweight or have diabetes, but it can also occur in those without these conditions. Symptoms may not be noticeable in the early stages, making it challenging to detect without medical testing.

Trial ID:
2023-506962-30-00
Protocol code:
NN9931-4553
Trial Phase:
Therapeutic confirmatory (Phase III)

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