Multicentre, randomised, double-blind, placebo-controlled, 48-week, Phase III trial to evaluate the efficacy and safety of survodutide administered subcutaneously in participants with overweight or obesity and presumed or confirmed nonalcoholic steatohepatitis (NASH)
This clinical trial is looking at whether a new medicine called survodutide can help treat liver inflammation and excess body weight. It is designed for adults who are overweight or living with obesity and have a condition called NASH, which is a build-up of fat that inflames the liver. Survodutide is given as a regular injection just under the skin. Over 48 weeks, doctors will test whether the medicine reduces fat in the liver by at least 30% and helps participants lose weight. Some people will receive the actual medicine, while others will receive a dummy injection called a placebo. This helps researchers compare the results fairly. Taking part involves regular health checks, MRI scans of the liver, and blood tests to monitor safety. The results could help provide a much-needed treatment for liver disease linked to weight.
At a glance
What is this study about?
Many people carry extra weight, and over time, this can cause fat to build up inside vital organs like the liver. When excess fat causes the liver to become irritated, swollen, and inflamed, doctors call this condition NASH (nonalcoholic steatohepatitis). If it is left untreated, this inflammation can damage the liver and lead to scarring over many years. Currently, there are very few approved medical treatments designed specifically to clear fat and inflammation from the liver.
This study is testing an investigational medicine called survodutide. Survodutide works by mimicking natural body signals that help control appetite and manage how the body processes energy and fat. Researchers hope that by targeting these pathways, the drug will encourage the body to shed excess weight while also clearing dangerous fat deposits directly from liver tissue.
In this Phase III trial, doctors want to confirm how well survodutide works compared to a placebo, which looks identical but contains no active medicine. Finding a medicine that treats both excess weight and liver inflammation together could make a big difference to long-term health, helping to protect people from serious liver damage, heart problems, and diabetes.
Key takeaways
- The trial tests a new injection called survodutide for people with excess weight and fatty liver inflammation.
- The main goal is to reduce liver fat by at least 30% and help participants lose body weight over 48 weeks.
- Participants will be randomly assigned to receive either the real study drug or a dummy injection (placebo).
- You will receive regular health checks, blood tests, and non-invasive liver scans throughout the study.
- Taking part is completely voluntary, and you can withdraw at any time.
Who may be eligible?
This trial is open to men and women aged 18 and older. To be considered, you must be carrying excess body weight (classified as overweight or living with obesity) and have evidence of fatty liver inflammation, either suspected by your doctor or confirmed through previous medical tests.
You will not be able to join if you have other causes of liver disease, such as damage caused primarily by heavy alcohol use or viral hepatitis. The study team will check your medical history to make sure your liver problems are linked to metabolic health and weight.
Other health conditions, such as severe kidney disease, certain heart problems, or pregnancy, may also mean the trial is not suitable for you. A full medical screening will take place before anyone can enrol to ensure taking part is completely safe.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you aged 18 or older?
- Are you currently overweight or living with obesity?
- Have you been diagnosed with, or suspected to have, a fatty or inflamed liver (NASH)?
- Are you able and willing to attend regular hospital or clinic appointments for 48 weeks?
- Are you willing to receive regular injections just under the skin?
What does participation involve?
Taking part in this study lasts for about 48 weeks (just under one year). During this time, you will be asked to give yourself an injection under the skin using a pre-filled pen, or have a carer or clinic nurse help you. You will be randomly chosen by a computer to receive either the active medicine (survodutide) or a dummy treatment (placebo). Neither you nor your study doctor can choose which one you receive.
You will need to attend regular clinic appointments so the team can keep a close eye on your health. These visits will involve routine checks like measuring your weight, waist size, and blood pressure. You will also have blood tests to see how your liver is functioning and have special MRI scans. These scans take detailed pictures of your liver to measure its fat levels, size, and stiffness without causing any pain. At the end of the 48 weeks, there will be follow-up checks to see how you are doing.
Potential risks and benefits
Locations (3)
- —UnverifiedGermany
- —UnverifiedSpain
- —UnverifiedNetherlands
Common questions
What is NASH?
NASH stands for nonalcoholic steatohepatitis. It is a condition where excess fat builds up in the liver, causing inflammation and swelling in people who drink little to no alcohol.
What is a placebo?
A placebo is a dummy treatment designed to look identical to the real medicine, but it contains no active ingredients. Comparing the two helps scientists prove whether changes are truly caused by the study drug.
How is the medicine given?
The study medicine is given as an injection just under the skin (subcutaneously), similar to how insulin is injected, using a simple pre-filled device.
Will having an MRI scan hurt?
No. MRI scans are completely painless. You will lie flat on a couch that slides into a tunnel-like scanner, which uses magnetic fields to take pictures of your liver.
Can I leave the trial if I change my mind?
Yes. Joining a clinical trial is entirely voluntary. You can stop taking part at any point, and your standard medical care will not be affected in any way.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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