Study on Efinopegdutide and Semaglutide for Adults with Non-Alcoholic Steatohepatitis (NASH) Before Cirrhosis

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What is this study about?

This clinical trial is focused on studying a liver condition called Non-alcoholic Steatohepatitis (NASH), which is a type of liver inflammation and damage caused by a buildup of fat in the liver. The study is testing a new treatment called efinopegdutide, also known by its code name MK-6024. This treatment is given as a solution for injection using a pre-filled syringe. The purpose of the study is to evaluate the effect of efinopegdutide compared to a placebo on the resolution of NASH without worsening liver fibrosis, which is the thickening and scarring of liver tissue, over a period of 52 weeks.

Participants in the study will receive either efinopegdutide or a placebo through subcutaneous injection, which means the injection is given under the skin. The study will last for about a year, during which the safety and tolerability of efinopegdutide will also be assessed. The main goal is to see if the treatment can help resolve NASH without making fibrosis worse. Additionally, the study will monitor any changes in body weight and any adverse events, which are unwanted effects that might occur during the study.

This trial is important for understanding how effective efinopegdutide is in treating NASH and ensuring it is safe for use. Participants will be closely monitored throughout the study to gather information on how well the treatment works and any side effects that may arise. The results of this study could provide valuable insights into new treatment options for people with NASH.

1 initial visit

Upon joining the study, the participant will attend an initial visit. During this visit, a healthcare professional will confirm eligibility based on specific criteria, including a liver biopsy to confirm the presence of non-alcoholic steatohepatitis (NASH).

The participant will be informed about the study procedures, potential risks, and benefits. Consent will be obtained before proceeding.

2 randomization

Participants will be randomly assigned to receive either the study medication, efinopegdutide, or a placebo. This process is double-blind, meaning neither the participant nor the study team will know which treatment is being administered.

3 treatment administration

The study medication, efinopegdutide, or placebo will be administered as a subcutaneous injection. This means the injection is given under the skin.

The treatment will be given regularly over a period of 52 weeks. The exact frequency and dosage will be explained by the healthcare team.

4 regular follow-up visits

Participants will attend regular follow-up visits throughout the study. These visits are essential for monitoring health, assessing the effects of the treatment, and ensuring safety.

During these visits, various assessments will be conducted, including physical examinations, blood tests, and questionnaires about health and well-being.

5 final assessment

At the end of the 52-week treatment period, a final assessment will be conducted. This will include a comprehensive evaluation of the participant’s health and the effects of the treatment.

The primary goal is to determine the resolution of NASH without worsening of liver fibrosis, as well as to evaluate any changes in body weight.

6 study completion

After the final assessment, the participant will complete the study. The healthcare team will discuss the results and any further steps or recommendations for ongoing care.

Who Can Join the Study?

  • You must have a confirmed diagnosis of Non-alcoholic steatohepatitis (NASH) through a liver biopsy. This means a small sample of your liver was taken to check for NASH.
  • Your liver biopsy must show a Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score of 4 or higher. This score measures liver damage and must include at least 1 point each for fat in the liver (steatosis), liver cell injury (ballooning), and liver inflammation.
  • Your liver biopsy must also show a NASH Clinical Research Network (CRN) fibrosis score indicating Stage 2 or 3. This score measures the amount of scar tissue in your liver.
  • You should not have a history of Type 2 diabetes mellitus (T2DM), or if you do, it must be controlled by diet or stable doses of medications that lower blood sugar.
  • You must be between the ages of 19 and 80 years old.
  • Both men and women can participate in the study.

Who Cannot Join the Study?

  • Patients with other liver diseases cannot participate.
  • Patients who have had liver transplants are not eligible.
  • Patients with a history of significant alcohol or drug abuse in the past year cannot join.
  • Patients with uncontrolled diabetes are excluded.
  • Patients with certain heart conditions are not eligible.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients with a history of cancer in the past 5 years, except for some skin cancers, are excluded.
  • Patients with certain infections, like hepatitis B or C, cannot join.
  • Patients who are participating in another clinical trial are not eligible.
  • Patients with any other medical condition that the study doctors think would make it unsafe to participate are excluded.

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
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Assistance Publique Hopitaux De Paris Paris France
Centre Hospitalier Universitaire De Nice Nice France
Unidade Local De Saude Do Alto Ave E.P.E. Guimaraes Portugal
Hospital General De Tomelloso Tomelloso Spain
SYNEXUS Magyarorszag Kft. Budapest Hungary
Centre Hospitalier Universitaire Rouen Rouen France
Klin Med s.r.o. Prague Czechia
Virgen del Rocío University Hospital Sevilla Spain
Universidade De Santiago De Compostela Santiago De Compostela Spain
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet Budapest Hungary
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Centre Hospitalier Lyon Sud Pierre Benite France
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Klinik Landstrasse Vienna Austria
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo Italy
Az Maria Middelares Gent Gent Belgium
Unidade Local De Saude Do Alto Minho E.P.E. Ponte De Lima Portugal
Krajska nemocnice Liberec a.s. Liberec Czechia
Hospital Universitario Virgen De La Victoria Malaga Spain
Alchhzpsko Pvkblkvq Hbzhuffa Dr Pvagd Paris France
Aojwijn Otpcrtblpdr Uctxcqlnfhzlo Capzeaspwlti Dscsy Sajqmc E Dxjkr Szaqjiu Da Tvglkf Turin Italy
Ufkejbsgyo Ox Aewyhsv Edegem Belgium
Hmhcdczo Ugebozaqybocg Mioilij Dx Vvyeerudae Santander Spain
Fakgcfcmx Pxys Ly Iqrwyggojgeye Bqolypfuv Dxu Hhdqqgdg Undaaahfnpfox Lv Pbj Madrid Spain
Cmc Cmech Rdxuodiqgnw Lyon France
Hwmsgceu Vjxy dphivesp Barcelona Spain
Hswsfccp Umkvxwnipuwhi dg A Cmhxah A Coruna Galicia Spain

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
01.07.2023
Belgium Belgium
Not recruiting
01.07.2023
Czechia Czechia
Not recruiting
01.07.2023
France France
Not recruiting
01.07.2023
Hungary Hungary
Not recruiting
01.07.2023
Italy Italy
Not recruiting
01.07.2023
Portugal Portugal
Not recruiting
01.07.2023
Spain Spain
Not recruiting
01.07.2023

Trial locations

Efinopegdutide is a medication being studied for its potential to help people with a liver condition called nonalcoholic steatohepatitis, or NASH. This condition involves the buildup of fat in the liver, which can lead to liver damage over time. The goal of using efinopegdutide in this trial is to see if it can help reduce the liver damage caused by NASH without making the liver’s condition worse. Researchers are also looking at how safe and tolerable this medication is for patients over a period of time.

Non-alcoholic steatohepatitis – Non-alcoholic steatohepatitis (NASH) is a liver disease characterized by inflammation and damage caused by a buildup of fat in the liver. It is part of a group of conditions known as non-alcoholic fatty liver disease (NAFLD). NASH progresses from simple fatty liver, where fat accumulates without causing harm, to a more severe form where inflammation and liver cell damage occur. Over time, this can lead to fibrosis, where scar tissue forms in the liver. If the condition continues to progress, it may result in cirrhosis, a severe scarring of the liver that can impair its function. NASH is often associated with obesity, insulin resistance, and metabolic syndrome.

Trial ID:
2022-502647-35-00
Protocol code:
MK-6024-013
Trial Phase:
Therapeutic exploratory (Phase II)

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