RecruitingPHASE3INTERVENTIONAL

LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Cirrhosis

This study, called LIVERAGE™, is for adults aged 18 and over who have a liver disease known as NASH or MASH with cirrhosis (scarring of the liver). The main goal is to see if a new medicine, survodutide, can help improve liver function. Participants will be split into two groups by chance: one group will receive survodutide and the other will receive a dummy treatment (placebo). Neither the participants nor their doctors will know which group they are in. Both groups will also receive regular advice on diet and exercise. The medicine or placebo is given as a weekly injection under the skin. The study will last up to four and a half years, involving regular check-ups to monitor health and treatment effects.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Boehringer Ingelheim

Enrolment target

1,590

Start

07 Nov 2024

Estimated completion

05 Jun 2029

Metabolic Dysfunction Associated Steatohepatitis

What is this study about?

This study, called LIVERAGE™, is exploring a new medicine named survodutide for people who have a specific type of liver disease. This condition is known as NASH (Non-Alcoholic Steatohepatitis) or MASH (Metabolic-Associated Steatohepatitis), which means there's fat in the liver causing inflammation and damage. Importantly, this study is for people whose liver disease has progressed to a stage where there is already significant scarring, known as cirrhosis. The researchers want to find out if survodutide can help to improve how well the liver works in these individuals.

NASH/MASH and cirrhosis can be serious conditions, and finding effective treatments is very important. This study aims to understand if survodutide could be a new way to help manage this liver disease. The study design ensures that neither you nor your study doctor will know whether you are receiving the active medicine or a 'dummy' treatment (placebo). This is a standard way to make sure the study results are as fair and accurate as possible, as it prevents any bias from knowing what treatment you're on.

Alongside the potential new medicine, all participants will also get regular guidance on making healthy lifestyle changes, such as adjustments to their diet and advice on regular exercise. This comprehensive approach hopes to give the best chance of understanding survodutide's impact while also promoting overall health.

Key takeaways

This study is testing a new medicine called survodutide for a liver disease called NASH/MASH with cirrhosis.
It's for adults aged 18 and over with specific BMI requirements.
Participants will get either survodutide or a placebo, given as a weekly injection.
Everyone in the study will also receive diet and exercise counselling.
The study lasts up to 4.5 years with regular clinic or video visits.
Your health will be closely monitored, and you can leave the study at any time.

Who may be eligible?

This study is looking for adults aged 18 or older who have been diagnosed with a liver condition called NASH or MASH that has led to liver scarring (cirrhosis). You would also need to have a body mass index (BMI) of 27 or higher, or 25 or higher if you are of Asian background. There are a few medical tests that would be done to confirm your liver health and suitability for the study.

However, some people won't be able to join. For example, if you have other serious liver conditions, or if you've had problems with too much alcohol consumption in the past five years, you wouldn't be eligible. Also, if your liver disease is very severe and has caused certain serious problems like internal bleeding or fluid build-up, you would not be able to take part.

Quick self-check

Are you 18 years old or older?
Do you have a diagnosis of NASH or MASH with cirrhosis (liver scarring)?
Is your BMI 27 or higher (25 or higher if you are of Asian background)?
Have you avoided heavy alcohol use for the past 5 years?
Do you currently not have other serious liver conditions or very severe liver complications?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, it could last for up to four and a half years. During this time, you will have regular check-ups, either by visiting the study clinic or through video calls. For the first year and a half, these visits will be every 2, 4, or 6 weeks. After that, you'll have visits every 3 months until the end of the study. You will give yourself a weekly injection under the skin of either survodutide or a placebo (a dummy medicine).

Throughout the study, doctors will closely monitor your health and any effects you experience, both good and bad. This includes regularly weighing you and doing special scans to check your liver. You will also be asked to complete questionnaires about how you are feeling and any symptoms you have. Importantly, all participants will receive ongoing support and advice on healthy eating and exercise.

Potential risks and benefits

Like all medical studies, there are potential benefits and potential risks. The main potential benefit is that survodutide might improve your liver function and slow down the progression of your liver disease. However, as this is a research study, there's no guarantee it will help you personally, and you might receive a placebo. Possible risks could include side effects from the medicine or the discomfort from injections and regular blood tests. Your health will be carefully monitored throughout the study to catch any problems early. Remember, participating in any clinical trial is entirely your choice, and you are free to withdraw at any time without giving a reason, and it will not affect your future medical care.

Locations (444)

The Institute for Liver Health II DBA Arizona Clinical Trials
Peoria, United States· Recruiting
Scottsdale Medical Specialists, Ltd
Scottsdale, United States· Recruiting
Adobe Clinical Research, LLC
Tucson, United States· Not yet recruiting
Arizona Liver Health - Tucson
Tucson, United States· Recruiting
Del Sol Research Management, LLC
Tucson, United States· Recruiting
Hope Clinical Research
Canoga Park, United States· Recruiting
Velocity Clinical Research-Chula Vista
Chula Vista, United States· Recruiting
Southern California Research Center
Coronado, United States· Recruiting
ARK Clinical Research
Fountain Valley, United States· Recruiting
Velocity Clinical Research-Huntington Park
Huntington Park, United States· Not yet recruiting
310 Clinical Research
Inglewood, United States· Recruiting
Velocity Clinical Research, San Diego
La Mesa, United States· Not yet recruiting

+432 more sites — see the official record for the full list.

Common questions

What is NASH/MASH?

NASH/MASH is a serious type of liver disease where fat builds up in the liver, leading to inflammation and damage, which can cause scarring (cirrhosis).

What is survodutide?

Survodutide is the name of the new medicine being tested in this study to see if it can help people with NASH/MASH and liver scarring.

What is a placebo?

A placebo is a 'dummy' treatment that looks exactly like the actual medicine but contains no active ingredients. It's used to fairly compare the real medicine's effects.

How long will I be in the study?

You could be in the study for up to four and a half years, with regular check-ups throughout this time.

Will I know if I'm getting the real medicine?

Neither you nor your study doctor will know whether you are receiving survodutide or the placebo. This helps make the study results more reliable.

How to find out more

Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com 1-800-243-0127 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.