Study of TGM-312-SC01 in Healthy Participants and Adults With MASH
This study is investigating a new medicine, TGM-312-SC01, for people with a liver condition called Metabolic Dysfunction-Associated Steatohepatitis (MASH). MASH is a serious liver disease that can lead to liver damage. We want to understand how safe the medicine is, how well the body handles it, and what effects it has. The study will involve giving different doses of the medicine to healthy volunteers and people with MASH. This research is in its early stages (Phase 1/2), meaning we're still gathering important information about the medicine before it can be considered for wider use. All participants will be closely monitored by medical staff.
At a glance
What is this study about?
This research is looking into a new treatment called TGM-312-SC01. It's designed to help people who have a liver condition called Metabolic Dysfunction-Associated Steatohepatitis, or MASH for short. MASH is a type of liver disease where too much fat builds up in the liver, leading to inflammation and damage. Over time, this can cause serious problems, including liver failure. There aren't many specific treatments for MASH yet, so finding new options is really important.
The main goal of this study is to find out more about TGM-312-SC01. We need to check if it's safe to use and how well people's bodies cope with it. We'll also be trying different doses to see which ones are best and how the medicine affects the body. This is an early-stage study, which is how all new medicines begin. We start by giving it to healthy volunteers, and then to people with the condition, to learn as much as possible.
This is a 'randomised, masked, placebo-controlled' study, which means some people will get the active medicine, and others will get a 'dummy' medicine (placebo), without knowing which one they have. This helps us ensure the results are accurate. The medicine is given as an injection under the skin. By doing this research, we hope to move closer to finding new ways to help people living with MASH.
Key takeaways
- This study is testing a new medicine, TGM-312-SC01, for the liver condition MASH.
- It's an early-stage study (Phase 1/2) focused on safety and understanding how the medicine works.
- Participants will receive either the active medicine or a 'dummy' placebo via injection.
- Close medical monitoring and regular clinic visits will be required.
- Taking part is voluntary, and you can leave the study at any time.
Who may be eligible?
To join this study, you need to be an adult between 18 and 70 years old and be able to understand and agree to take part. All participants will have a health check to make sure the study is suitable for them.
If you have MASH and want to take part, your doctor will check that your condition fits the specific requirements for the study. This helps make sure that the study medicine is being tested in the right group of people.
There are also some reasons why you might not be able to join. For example, if you have a significant health issue that could make taking part risky, or if you've recently taken part in another research study. Taking certain other medicines might also mean you can't 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 18 and 70 years old?
- Are you able to understand and sign a consent form?
- Do you have MASH (if applying for that part of the study)?
- Have you spoken to your doctor about your general health?
- Are you not currently taking part in another drug study?
What does participation involve?
If you decide to take part, you'll be given the study medicine, TGM-312-SC01, or a placebo (dummy medicine), through an injection under your skin. You won't know whether you're getting the active medicine or the placebo.
You'll need to attend several appointments at the study clinic. During these visits, the study doctors and nurses will carry out various checks and tests to monitor your health and see how your body is reacting to the medicine. These tests might include blood samples, physical exams, and other assessments specific to the liver.
The healthy volunteers will receive a single dose and be monitored for a period. Participants with MASH will receive multiple doses over time. The total length of your participation will depend on which part of the study you are in, and the study team will explain this fully before you decide to join.
Potential risks and benefits
Locations (1)
- Richmond PharmacologyVerified postcodeLondon, United Kingdom· Recruiting
Common questions
What is MASH?
MASH stands for Metabolic Dysfunction-Associated Steatohepatitis. It's a serious liver disease where fat builds up in the liver, causing inflammation and damage.
What is a 'placebo'?
A placebo is a 'dummy' medicine that looks like the real medicine but contains no active ingredients. It helps researchers compare the effects of the active medicine more accurately.
Will I know if I'm getting the real medicine or the placebo?
No, this is a 'masked' study, meaning neither you nor the study team will know whether you are receiving the active medicine or the placebo.
What does 'Phase 1/2' mean?
It means this is an early stage of research. Phase 1 tests safety in healthy people, and Phase 2 checks safety and early effectiveness in people with the condition.
How is the medicine given?
The medicine, TGM-312-SC01, is given as an injection just under the skin (subcutaneous injection).
How to find out more
Sponsor Clinical Trials Office
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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