Active not recruitingPHASE4INTERVENTIONAL

Combined Active Treatment in Type 2 Diabetes with NASH

This research study is investigating new treatments for a liver condition called Non-alcoholic Steatohepatitis (NASH), which is common in people with type 2 diabetes. Currently, there are no specific medications approved for NASH. This study aims to see if two existing diabetes medicines, empagliflozin and semaglutide, either alone or together, can help improve liver health in these patients. We need volunteers aged 25 to 75 who have type 2 diabetes and NASH, but haven't developed advanced liver scarring (cirrhosis). Participants will receive either one of the medicines, a combination of both, or a placebo (a dummy pill) over 48 weeks. Liver biopsies will be taken at the start and end of the study to check for improvements. Your participation could help find much-needed treatments for this serious liver condition.

At a glance

Status

Active not recruiting

Phase

PHASE4

Sponsor

German Diabetes Center

Enrolment target

192

Start

26 Mar 2021

Estimated completion

01 Dec 2025

Type 2 Diabetes Non-alcoholic Steatohepatitis (NASH)Non-alcoholic Fatty Liver Disease (NAFLD)

What is this study about?

Many people with type 2 diabetes also have a liver condition called Non-alcoholic Fatty Liver Disease (NAFLD). A more serious form of this condition is Non-alcoholic Steatohepatitis, or NASH. If you have type 2 diabetes and NASH, you're at a higher risk of developing more severe liver problems. Sadly, NASH can lead to serious health issues, including greater risk of liver-related death and heart problems.

At the moment, there aren't any specific medications approved for treating NASH in people with type 2 diabetes. This means doctors don't have dedicated ways to help patients with this condition improve their liver health. That's why this study is so important; it's looking for new solutions.

This study will investigate two medicines that are already used for type 2 diabetes: empagliflozin and semaglutide. We want to see if these medicines, used either on their own or together, can help improve the liver changes seen in NASH. By taking part, you could help us find effective treatments that could improve the lives of many people with type 2 diabetes and NASH.

Key takeaways

New study for NASH in people with type 2 diabetes.
Testing two existing diabetes medicines (empagliflozin and semaglutide).
Aims to find the first specific treatments for NASH.
Requires a liver biopsy before and after treatment to check progress.
Participation could help improve care for many patients.

Who may be eligible?

To be considered for this study, you would need to:

Be between 25 and 75 years old. Have a diagnosis of type 2 diabetes and a confirmed diagnosis of NASH, but without severe liver scarring (known as cirrhosis). Your diabetes control, measured by something called HbA1c, should be at or below 9.5%.

There are also some reasons why you wouldn't be able to join. These include having other types of liver disease (like Hepatitis B or C), a history of heavy alcohol use, or certain other medical conditions. If you've ever had diabetic ketoacidosis (a serious diabetes complication) or used certain medications that can affect the liver, you also wouldn't be able to take part. Women who are pregnant, breastfeeding, or planning to become pregnant during the study would also not be able to join.

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 between 25 and 75 years old?
Do you have type 2 diabetes and confirmed NASH?
Is your HbA1c (a diabetes blood test) 9.5% or lower?
Are you able to undergo a liver biopsy?
Are you not pregnant, breastfeeding, or planning to get pregnant soon?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be assigned to one of three groups by chance, like flipping a coin. You won't know which group you're in, and neither will your doctors (this is called 'double-blind'). You'll either receive: * Empagliflozin tablets combined with injections of semaglutide. * Empagliflozin tablets combined with 'dummy' injections (placebo). * 'Dummy' empagliflozin tablets (placebo) combined with 'dummy' injections (placebo).

The medication will be taken for 48 weeks (about 11 months). To check your liver health, you will need to have a liver biopsy before you start the treatment and another one at the end of the 48-week period. There will also be regular check-ups, blood tests, and assessments throughout the study to monitor your health and how the treatment is working. We cannot tell you the exact number of visits, but typically studies like this involve several clinic visits over the 48-week period. The overall duration you'd be involved in the study would be slightly longer than 48 weeks to allow for initial screening and final follow-up tests.

Potential risks and benefits

Potential benefits of participating include gaining access to new treatments before they are widely available and contributing to medical knowledge that could help future patients with NASH and type 2 diabetes. There are potential risks associated with any medical study, including side effects from the study medications (though these are already approved drugs, so common side effects are known) and discomfort or rare complications from procedures like liver biopsies. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (26)

Medizinische Universität Graz
Verified postcode
Graz, Austria
Medizinische Universität Innsbruck
Verified postcode
Innsbruck, Austria
Wiener Gesundheitsverbund, Klinik Landstraße
Verified postcode
Vienna, Austria
Medizinische Universität Wien
Verified postcode
Vienna, Austria
Wiener Gesundheitsverbund, Klinik Hietzing
Verified postcode
Vienna, Austria
German Diabetes Center
Verified postcode
Düsseldorf, Germany
Herz- und Diabeteszentrum NRW
Verified postcode
Bad Oeynhausen, Germany
Franziskus-Krankenhaus Berlin
Verified postcode
Berlin, Germany
Leber- und Studienzentrum Checkpoint
Verified postcode
Berlin, Germany
University Clinics Berlin Charité
Verified postcode
Berlin, Germany
University Clinics Berlin Charité
Verified postcode
Berlin, Germany
University Clinics Bochum
Verified postcode
Bochum, Germany

Common questions

What is NASH?

NASH stands for Non-alcoholic Steatohepatitis, which is a serious type of fatty liver disease that can cause inflammation and liver damage.

What is a placebo?

A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active ingredients. It helps researchers compare the effects of the actual medicine.

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

No, you won't know if you're getting the active medicine or the placebo. This is to make sure the study results are as fair and accurate as possible.

What happens if I decide to leave the study early?

You are free to leave the study at any time, for any reason. Your decision will not affect your regular medical care.

Why do I need a liver biopsy?

A liver biopsy is used to get a small sample of your liver tissue. This is the best way to confirm you have NASH and to see if the treatment has made any improvements to your liver.