Study on Efinopegdutide for Adults with Compensated Cirrhosis Due to Metabolic Dysfunction-Associated Steatohepatitis

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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 can lead to a type of liver scarring called compensated cirrhosis. The study will evaluate a treatment called efinopegdutide, also known by its code name MK-6024. This treatment is administered as a solution for injection using a pre-filled syringe. The purpose of the study is to assess the effect of efinopegdutide on reducing liver fat content and to evaluate its safety and tolerability.

Participants in the study will receive either efinopegdutide or a placebo, which is a substance with no active medication. The study will last for 28 weeks, during which the changes in liver fat content will be monitored. The study will also track any side effects experienced by participants and whether any participants discontinue the treatment due to these effects. The goal is to understand how efinopegdutide affects liver health and its safety for patients with MASH.

Throughout the study, various health indicators will be measured, including changes in liver stiffness and body weight. These measurements will help researchers determine the overall impact of efinopegdutide on liver health. The study aims to provide valuable insights into the potential benefits and risks of using efinopegdutide for treating MASH-related liver conditions.

1 joining the study

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

2 medication administration

The medication, efinopegdutide, is administered as a subcutaneous injection. This means it is injected under the skin using a pre-filled syringe.

The treatment will be given regularly over a period of 28 weeks. The exact frequency of the injections will be specified by the study protocol.

3 monitoring and assessments

Throughout the 28-week period, the participant’s liver fat content will be monitored to evaluate the effect of the treatment.

Safety and tolerability will also be assessed by tracking any adverse events or side effects experienced during the study.

4 end of treatment evaluation

At the end of the 28 weeks, a final assessment will be conducted to measure changes in liver fat content and other health indicators.

The study will also evaluate any changes in body weight and other specific health markers related to liver function.

Who Can Join the Study?

  • The patient must have a diagnosis of compensated cirrhosis due to metabolic dysfunction-associated steatohepatitis (MASH). This can be confirmed by a liver tissue test or specific blood and imaging tests.
  • The patient should either have no history of type 2 diabetes mellitus (T2DM) or have T2DM that is well-controlled. This means their glycated hemoglobin (A1C) level should be 9% or lower, and their diabetes should be managed by diet or stable doses of diabetes medications.
  • The patient can be of any sex or gender and must be between 18 and 80 years old.
  • If the patient was assigned female sex at birth, they must not be pregnant or breastfeeding. If they can become pregnant, they must use a highly effective birth control method, have a negative pregnancy test, and not breastfeed during the study and for at least 5 weeks after the last dose of the study medication. Their medical history, menstrual history, and recent sexual activity will be reviewed by the study doctor.

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Bordeaux Bordeaux France

Other Sites

Site Name City Country Status
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Clinico Universitario De Valladolid Valladolid Spain
Virgen del Rocío University Hospital Sevilla Spain
Universidade De Santiago De Compostela Santiago De Compostela Spain
Centre Hospitalier Universitaire De Nice Nice France
Hospital General De Tomelloso Tomelloso Spain
Hopital Beaujon Clichy France
Hqugxahi Usexfhyjtjfmo Mmnzucx Dr Vrntnjntmw Santander Spain
Cahwli Hpvpsdyjykg Eb Uvgvjrhxezhlj De Lhjcydl Limoges France
Fduugrkci Prkk Lm Iwbinkokqvnpc Bejpffdbp Ddh Hjufzzlr Ukwhpopixdjun Lg Pox Madrid Spain
Con Cdxnj Rbytsetyqgn Lyon France
Hswahmkz Vmlq dbfzwhrc Barcelona Spain
Hmijyqgj Ubvyaksrtrzji da A Ckejxv 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
France France
Not recruiting
11.07.2024
Spain Spain
Not recruiting
11.07.2024

Trial locations

Investigated drugs:

Efinopegdutide (MK-6024) is a medication being studied for its potential to reduce liver fat content in adults with compensated cirrhosis due to metabolic dysfunction-associated steatohepatitis. The trial aims to assess how effective this medication is in decreasing liver fat and to evaluate its safety and tolerability over a period of 28 weeks.

Metabolic Dysfunction-Associated Steatohepatitis – This disease is characterized by the accumulation of fat in the liver, which is not caused by alcohol consumption. Over time, this fat buildup can lead to inflammation and damage to liver cells. As the condition progresses, it may cause scarring of the liver tissue, known as fibrosis. This scarring can interfere with the liver’s ability to function properly. The disease is often associated with metabolic conditions such as obesity, type 2 diabetes, and high cholesterol. It is a part of a broader spectrum of liver diseases known as non-alcoholic fatty liver disease (NAFLD).

Trial ID:
2024-510923-20-00
Protocol code:
MK-6024-017
NCT ID:
NCT06465186
Trial Phase:
Therapeutic exploratory (Phase II)

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