RecruitingPHASE3INTERVENTIONAL

A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes)

This research study, called SYNERGY-Outcomes, is for adults throughout the UK who have a condition called Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD). This is a type of fatty liver disease. The main goal is to find out if two new medications, called retatrutide and tirzepatide, can prevent serious liver problems from developing in people with MASLD who are at higher risk. Participants will be randomly assigned to receive either one of the study medications or a placebo, which is a dummy medicine with no active drug. This helps researchers understand the true effects of the new drugs. About 4,500 adults are expected to join this important study, which will last for around 4 years.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Eli Lilly and Company

Enrolment target

4,500

Start

15 Oct 2025

Estimated completion

01 Aug 2032

Metabolic Dysfunction-Associated Steatotic Liver Disease

What is this study about?

This study, called SYNERGY-Outcomes, is carefully examining a liver condition known as Metabolic Dysfunction-Associated Steatotic Liver Disease, or MASLD for short. This is a common condition where too much fat builds up in the liver, which can sometimes lead to more serious liver problems over time. The main purpose of this research is to see if two investigational new medicines, called retatrutide and tirzepatide, can help prevent these serious liver issues in adults who have MASLD and are considered to be at a higher risk of their condition worsening.

We understand that hearing about medical conditions and clinical trials can be overwhelming, so we want to assure you that this study is being conducted with great care and attention to participant safety. The medications being tested are designed to work in specific ways that might help manage MASLD. By preventing serious liver problems, these drugs could potentially improve the health and quality of life for many people living with this condition. The study is particularly interested in those whose liver scans or blood tests suggest they are at a higher risk, to see if these new treatments can make a significant difference for them.

Taking part in a study like this is a big decision, and it’s important to remember that such research is crucial for developing better treatments for future patients. If these medicines prove to be effective, they could offer new hope and options for managing MASLD more successfully than current approaches. It's a journey of discovery, and every participant plays a vital role in helping us learn more about this condition and its potential treatments.

Key takeaways

This study investigates new treatments for a specific type of fatty liver disease (MASLD).
It aims to prevent serious liver problems in individuals at higher risk.
Participants will receive either a new drug or a dummy medicine (placebo).
The study involves regular clinic visits and lasts about 4 years.
An optional 2-year extension study with active treatment is available afterwards.

Who may be eligible?

To join this study, adults must have a specific type of fatty liver disease called MASLD. Doctors will use special tests, like scans and blood tests, to confirm you have enough fat in your liver and that your liver stiffness falls within a certain range (between 10 and 20 kPa).

There are also some reasons why someone might not be able to join. For example, if you have another type of liver disease not related to MASLD, a very low body mass index (BMI under 25), or if you’ve had serious liver problems in the past like fluid build-up or bleeding from liver issues. You also can't join if you’ve lost a lot of weight (over 11 pounds) very quickly in the last three months, have very high blood sugar (HbA1c over 10%), or have type 1 diabetes.

Quick self-check

Do I have Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)?
Is my liver fat content 8% or more?
Are my liver stiffness scores (from a special scan) between 10kPa and 20kPa?
Do I have a body mass index (BMI) of 25 or higher?
Have I NOT had any other serious liver diseases in the past?
Have I NOT lost more than 11 pounds in the last 3 months unintentionally?

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

What does participation involve?

If you decide to take part in this study, you will be in the study for about 4 years (or 224 weeks). During this time, you'll have between 25 to 30 visits to the clinic. At these visits, the study team will carefully check your health, perform various tests to monitor your liver and overall well-being, and assess how your condition is progressing. You will be randomly chosen to receive either one of the new study medications (retatrutide or tirzepatide) or a placebo (a dummy medicine without any active drug).

After the main study finishes, there's an optional extra 2-year study you might be able to join. In this extension study, everyone will receive one of the active medications, even if they were on the placebo during the main part of the study. This ensures that all participants can potentially benefit from the new treatments in the longer term.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving close medical monitoring and access to new investigational treatments for MASLD that are not yet widely available. However, there are also potential risks, as the study drugs could cause side effects, similar to any medicine. The study team will monitor you closely for any unwanted effects. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without affecting your regular medical care.

Locations (561)

MFA Clinical Research
Tuscaloosa, United States· Recruiting
The Institute for Liver Health II dba Arizona Clinical Trials - Chandler
Chandler, United States· Recruiting
Spectrum Research Institute
Gilbert, United States· Recruiting
The Institute for Liver Health II dba Arizona Liver Health - Peoria
Peoria, United States· Recruiting
Epic Medical Research-Sun City
Sun City, United States· Recruiting
The Institute for Liver Health II dba Arizona Clinical Trials - Tucson
Tucson, United States· Recruiting
Del Sol Research Management, LLC
Tucson, United States· Recruiting
Arkansas Gastroenterology - North Little Rock
North Little Rock, United States· Recruiting
San Fernando Valley Health Institute
Canoga Park, United States· Recruiting
Ark Clinical Research - Fountain Valley
Fountain Valley, United States· Recruiting
Fresno Clinical Research Center
Fresno, United States· Recruiting
UCSD - Altman Clinical and Translational Research Institute (ACTRI)
La Jolla, United States· Recruiting

+549 more sites — see the official record for the full list.

Common questions

What is MASLD?

MASLD stands for Metabolic Dysfunction-Associated Steatotic Liver Disease. It's a common condition where too much fat builds up in your liver, often linked with other health issues like obesity or type 2 diabetes.

What is a placebo?

A placebo is a 'dummy' treatment that looks just like the study drug but contains no active medicine. It helps researchers compare the effects of the new drugs to see if they truly work.

How long will the study last?

The main part of the study will last for about 4 years (224 weeks). There's also an optional 2-year extension study you could join afterwards.

Will I know if I'm getting the drug or placebo?

No, participants will not know whether they are receiving the active drug or the placebo during the main study. This helps ensure the study results are unbiased and reliable.

What happens after the study ends?

Once the main study is complete, you might be eligible to join an optional 2-year extension study where all participants will receive one of the active study medications.

How to find out more

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

LillyTrials@Lilly.com 1-317-615-4559 Official trial record

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