Study on the Effectiveness of NNC0194-0499 and Semaglutide in Treating Non-Alcoholic Steatohepatitis (NASH) in Patients with Fibrosis Stages 2-4

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What is this study about?

This clinical trial is focused on studying a liver condition called non-alcoholic steatohepatitis (NASH). NASH is a type of liver disease that occurs when fat builds up in the liver, causing inflammation and damage. The study is investigating the effects of two medications, NNC0194-0499 and Semaglutide, which are being tested to see if they can help improve liver health in people with NASH. The medications are given as injections under the skin, and the study will compare their effects to a placebo.

The purpose of the study is to determine if the combination of NNC0194-0499 and Semaglutide can improve liver fibrosis, which is the scarring of liver tissue, in people with NASH. Participants in the study will receive weekly injections for a period of 52 weeks. The study will monitor changes in liver health, including improvements in liver fibrosis and the resolution of steatohepatitis, which is the inflammation of the liver due to fat accumulation.

Throughout the study, participants will be closely monitored to assess any changes in their liver condition and overall health. The study aims to provide valuable information on whether these medications can be an effective treatment option for people with NASH, potentially leading to better management of this liver disease. The trial is designed to ensure the safety and well-being of all participants while gathering important data on the effectiveness of the treatment.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including age and medical history related to non-alcoholic steatohepatitis (NASH).

2 initial assessment

An initial assessment is conducted, which includes a liver biopsy to confirm the presence of NASH and determine the stage of liver fibrosis.

3 medication administration

The study involves the administration of two medications: NNC0194-0499 and semaglutide. NNC0194-0499 is given at a dose of 30 mg once weekly, and semaglutide is given at a dose of 2.4 mg once weekly. Both medications are administered as a solution for injection under the skin (subcutaneous).

A placebo may also be administered once weekly as part of the study design.

4 weekly follow-ups

Weekly follow-up visits are scheduled to monitor the effects of the medication and assess any side effects. These visits continue for the duration of the study.

5 mid-study evaluation

At the midpoint of the study, an evaluation is conducted to assess the progress of liver fibrosis and any changes in the condition of NASH.

6 final assessment

At the end of the 52-week period, a final assessment is performed. This includes a repeat liver biopsy to evaluate changes in liver fibrosis and NASH.

Additional tests may be conducted to measure changes in liver function and other health indicators.

7 completion of study

Upon completion of the study, results are analyzed to determine the effectiveness of the medication combination in improving liver fibrosis and NASH.

Who Can Join the Study?

  • Must be at least 18 years old. In some countries, the minimum age is higher: 19 years in the Republic of Korea, 20 years in Japan, and 21 years in Singapore.
  • Must have NASH (Non-alcoholic steatohepatitis) confirmed by a liver biopsy, which is a small sample of liver tissue examined under a microscope. This biopsy can be from up to 180 days before the first visit.
  • Must have fibrosis (scarring of the liver) at stage 2, 3, or 4, as determined by a liver biopsy.
  • Must have a NAFLD activity score (a measure of liver disease activity) of 4 or more for those with fibrosis stage 2 or 3, or 3 or more for those with fibrosis stage 4. This score includes at least 1 point each for steatosis (fat in the liver), lobular inflammation (swelling in the liver), and hepatocyte ballooning (swelling of liver cells).

Who Cannot Join the Study?

  • Patients who have a different liver condition other than Non-alcoholic steatohepatitis (NASH) cannot participate. NASH is a liver disease that happens when fat builds up in the liver, causing inflammation and damage.
  • Patients who do not have liver fibrosis at stage 2 to 4 are excluded. Fibrosis is the thickening and scarring of tissue, and stages 2 to 4 indicate the severity of this condition in the liver.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are part of a vulnerable population, such as those who cannot give consent or are in a dependent relationship with the study staff, are not eligible.

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
Universitair Ziekenhuis Gent Gent Belgium
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Ippokratio General Hospital Of Thessaloniki Thessaloniki Greece
Centrum Medyczne Intercor Sp. z o.o. Bydgoszcz Poland
Hospital Clinico Universitario De Valladolid Valladolid Spain
Unidade Local De Saude De Matosinhos E.P.E. Senhora Da Hora Portugal
Centre De Recherche Clinique Portes Du Sud Venissieux France
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Azienda Ospedaliera di Padova Padua Italy
Hippokration Hospital Athens Greece
ID Clinic Myslowice Poland
University General Hospital Of Thessaloniki Ahepa Thessaloniki Greece
Virgen del Rocío University Hospital Sevilla Spain
Odense University Hospital Odense Denmark
Universita’ Campus Bio-medico Di Roma Rome Italy
Universita’ Di Pisa Pisa Italy
Universita’ Politecnica Delle Marche Ancona Italy
Centrum Badan Klinicznych Piotr Napora Lekarze sp.p. Wroclaw Poland
Ko-Med Centra Kliniczne Sp. z o.o. Zamosc Poland
Centre Hospitalier Universitaire De Nantes Nantes France
Diagnostic Consultation Center XX-Sofia EOOD Sofia Bulgaria
Centrum Medyczne Medyk Sp. z o.o. Rzeszow Poland
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Krajska nemocnice Liberec a.s. Liberec Czechia
Ciwhyzijq Ujhjpccjjgcrrp Sfqhisqqc Woluwe-Saint-Lambert Belgium
Hrgzjnxm Hvplkrwr Hvidovre Denmark
Hwkjtupk Uyjvmoroyruck Mmohpnz Do Vfofcaworm Santander Spain
Lklbw Gmjgdxn Hxhjddso Oq Azhetv Athens Greece
Pkmmpkcbmhd Ejhpzamcibnn Wroclaw Poland
Hroyue Hqjhrkzw Herlev Denmark
Untnxktiyenuxhrzvnssu Wocxtzbqe Asn Wuerzburg Germany
Aprhjas Upwfl Slhdwxqfs Ldqnco Da Baipxck Bologna Italy
Uhjhfktlyr Ox Awooilz Edegem Belgium
Avlhpdi Ohtqipgfaad Psyk Gzdszohj Xhyoc Bergamo Italy
Cnosta Hwmfkvzlpkw Rnaljfez Dpiblxkouiuacf Angers France
Hfcwmsyc Vxzx dhkcldmw Barcelona Spain

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
01.09.2021
Bulgaria Bulgaria
Not recruiting
01.09.2021
Czechia Czechia
Not recruiting
01.09.2021
Denmark Denmark
Not recruiting
01.09.2021
France France
Not recruiting
01.09.2021
Germany Germany
Not recruiting
01.09.2021
Greece Greece
Not recruiting
01.09.2021
Italy Italy
Not recruiting
01.09.2021
Poland Poland
Not recruiting
01.09.2021
Portugal Portugal
Not recruiting
01.09.2021
Spain Spain
Not recruiting
01.09.2021

Trial locations

NNC0194-0499 is an investigational medication being studied for its potential effects on liver fibrosis in patients with non-alcoholic steatohepatitis (NASH). It is administered once a week and is being tested to see how well it works in reducing liver damage when used alongside another medication.

Semaglutide is a medication that is already used for other health conditions, such as diabetes and weight management. In this trial, it is given once a week to see if it can help improve liver health in patients with NASH when used together with NNC0194-0499.

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 liver fibrosis, where scar tissue forms in the liver, and potentially to cirrhosis, which is severe scarring that affects liver function. The disease often develops in individuals who are overweight or have diabetes, but it can occur in others as well. Symptoms may not be noticeable in the early stages, but as the disease progresses, it can lead to fatigue, weakness, and discomfort in the upper right abdomen. The progression of NASH can vary, with some individuals experiencing a slow progression and others developing more severe liver damage over time.

Trial ID:
2023-506961-74-00
Protocol code:
NN9500-4656
Trial Phase:
Therapeutic exploratory (Phase II)

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