RecruitingPhase I/IIInterventional

A Phase I/II study of TGM-312-SC01 in healthy participants and adults with metabolic dysfunction-associated steatohepatitis

This study is looking at a new medicine called TGM-312-SC01. It's for a liver condition called MASH (Metabolic dysfunction-associated steatohepatitis), which is when too much fat builds up in the liver, leading to inflammation and scarring. This study is the first time this medicine is being given to people. Researchers want to check if it's safe for healthy volunteers and adults with MASH. They also want to see if there are any early hints that the medicine might help people with MASH. Participants will receive injections of the medicine or a dummy treatment and will have several check-ups over about 16 weeks. The study will take place in London, UK, from February 2026 to September 2028.

At a glance

Status

Recruiting

Phase

Phase I/II

Sponsor

Tangram Therapeutics plc

Enrolment target

Start

16 Feb 2026

Estimated completion

05 Apr 2028

Metabolic dysfunction-associated steatohepatitis (MASH)

What is this study about?

MASH, also known as Metabolic dysfunction-associated steatohepatitis, is a serious liver condition. It's part of a wider problem called MASLD (Metabolic dysfunction-associated steatotic liver disease), where too much fat collects in the liver, not because of drinking too much alcohol. If MASLD gets worse, it can lead to inflammation, scarring (fibrosis), and eventually severe liver damage (cirrhosis) or even liver failure. Many things can contribute to MASH, like being overweight, problems with how the body uses sugar and fats, and even gut bacteria.

At the moment, there aren't many specific treatments for MASH, so researchers are always looking for new ways to help. This study is testing a new medicine called TGM-312-SC01. It's the very first time this medicine will be given to people. The main goals are to find out two key things: first, if the medicine is safe for people to take, and second, to see if there are any early signs that it might actually help improve the condition in people with MASH.

This is a 'Phase I/II' study, which means it has two main parts. The first part focuses on safety, giving the medicine to healthy volunteers. The second part involves people with MASH, where researchers will continue to check for safety while also looking for any early hints that the medicine might be making a positive difference to their liver condition.

Key takeaways

This is a study for a new medicine for the liver condition MASH.
It's the first time this medicine has been given to people.
The study aims to check how safe the medicine is and if it shows early signs of working.
Participation involves injections and several visits for check-ups over about 20 weeks.
Healthy volunteers and adults with MASH may be able to join.
The study takes place in London, UK.

Who may be eligible?

This study is looking for two groups of people: healthy volunteers and adults who have been diagnosed with MASH.

To join, you need to be an adult between 18 and 70 years old. You must be able to understand the study information and be willing to sign a consent form. The study doctors will also check your overall health to make sure it's safe for you to take part.

You wouldn't be able to join if you have other serious medical conditions, have recently been part of another medical study, or are taking medicines that could interfere with this trial. The study doctors will carefully review your health to make sure it's the right fit for you.

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 18 and 70 years old?
Are you able to provide written consent and understand the study?
Do you have a diagnosis of MASH (if joining the MASH group)?
Do you have any other significant health conditions?
Have you participated in another research study recently?
Are you taking any medications that might interfere with the study?

Answer every question to see your result.

What does participation involve?

If you join this study, you would either receive the new medicine, TGM-312-SC01, or a 'dummy' treatment (placebo). Neither you nor the study team would know which one you're getting. Both are given as an injection under the skin.

Healthy volunteers will receive one injection. People with MASH will receive two injections, about four weeks apart. After your last injection, everyone will be looked after for 16 weeks. During this time, you'll need to visit the study site up to seven times. These visits will involve simple checks like blood tests, measuring your blood pressure and pulse, and physical exams. You'll also have scans of your liver.

If you have MASH, you will also have a liver biopsy (a small sample of liver tissue) taken twice: once before you start treatment and again towards the end of the study. The total time you'd be involved in the study would be around 20 weeks.

Potential risks and benefits

Because this is the first time this new medicine has been given to people, we don't yet know if it will have any benefits for people with MASH. For healthy volunteers, there is no expected health benefit from taking part. The main aim for them is to help researchers understand the safety of the new medicine. Since this medicine is new, its possible risks are not fully known. There are always some small risks with study procedures, like bruising from injections or blood tests. For those having liver biopsies, there's a small risk of discomfort at the biopsy site, temporary low blood pressure, or minor bleeding. You have the right to withdraw from the study at any time, for any reason, by telling the study team.

Locations (2)

Kings College Hospital
Approximate
London, England
Richmond Pharmacology Clinical Trial Unit,
City only
London, England

Common questions

What is MASH?

MASH (Metabolic dysfunction-associated steatohepatitis) is a liver condition where too much fat builds up in the liver, causing inflammation and scarring, which can lead to serious liver damage.

What is TGM-312-SC01?

TGM-312-SC01 is a new medicine being tested for MASH. This study is the first time it's being given to people to check its safety and early effects.

Will I know if I'm getting the real medicine or the dummy treatment?

No, you won't know, and neither will the study team. This is a common practice in studies to make sure the results are fair and accurate.

Where and when will the study take place?

Healthy volunteers will be seen at Richmond Pharmacology in London, UK. People with MASH will go to King's College Hospital Research Unit in London, UK. The study is expected to run from February 2026 to September 2028.

What is a liver biopsy?

A liver biopsy is a procedure where a very small piece of your liver is removed with a needle for closer examination under a microscope. It helps doctors understand the health of your liver.

How to find out more

Clinical Trials Office

clinicaltrials@tangramtx.com +44 (0)20 4558 3826 Official trial record

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