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Clinical Study Background
We are conducting a clinical study to understand how a new investigational medicine may help people with Metabolic Dysfunction Associated Steatohepatitis (MASH). In this clinical study, we are recruiting male and female participants aged 18 to 70 years (inclusive) with MASH.
We will see if repeated doses of TGM-312-SC01 have any important side effects when given by injection under the skin and see how well your body is able to handle the study medicine. As part of the study, we may take blood samples at different times to measure the levels of TGM-312-SC01 in the bloodstream over time. This helps us understand what the body does to the medicine and also to see if the medicine has an effect on your condition.
This part of the study in participants with MASH consists of two parts. The specific tests and number of blood samples will depend on which part of the study you choose to enrol in.
If you are interested in taking part in the study,
- You will need to attend screening appointments so we can check if you are suitable to take part in the study. At this appointment, we will take blood, check your heart and carry out a physical examination.
- Screening period will consist of up to three visits and can take up to 10 weeks. Additional visits may be scheduled as necessary.
- The third screening visit will depend on whether you have had a liver biopsy in the last 12 months. If you have had and the sample can be obtained, you will not need to attend this visit. If you do need to attend, you will need to have a liver biopsy taken. You will be admitted a day prior to the biopsy and discharged on the day.
- If results from your screening appointment show you are suitable for the study, you will be invited to take part.
- You will be admitted to the study site on Day-1 before dosing.
- During your treatment period, you will receive a single injection under the skin of either the new investigational medicine or a dummy (placebo) treatment on Day 1.
- We will conduct a number of assessments (like those we did at screening) to check how safe and tolerable the investigational medicine is, how long the drug remains in your body, and how your body processes it.
- You will be discharged from the unit on Day 2. Part C participants are not required to undergo Day 2 tests.
- You will return to the site two weeks after you receive the study treatment for some tests and procedures.
- You will receive a second dose of the same study treatment four weeks after you have been given the first dose of study treatment at Week 4. You will receive the same study treatment via an injection under the skin. You will be admitted on Day 28, a day before your dosing on Day 29 (Week 4) and discharged on the same day.
- After your second dose of the study treatment, you will return to the site for scheduled appointments at Week 6, Week 8, Week 12 and Week 16 of the study. You will have a liver biopsy at Week 16. You will be admitted a day prior to the biopsy and discharged on the day. You may need to attend additional follow-up visits.
- Sixteen weeks after you receive the second dose of the study treatment, you will return to the site for the last visit of the study for follow-up at Week 20.
- This will involve a stay of 5 nights in our study unit.
- This means the whole process may take approximately 7 months from your screening visit through to your final visit.
- In total, if you are included in the clinical study, you will come to the study unit 11 times. You may be requested to stay at the study site for longer if deemed necessary.
Who can take part?
You may be eligible to take part in this clinical study if you:
- Are aged between 18 - 70 years (inclusive).
- Have body mass index (BMI) within the range of ≥27 to<40 kg/m2 (inclusive) at screening.
- Have at least one component of metabolic syndrome: obesity, high blood fats, high blood pressure, high blood sugar, or type 2 diabetes.
- Agree to comply with the contraception requirements of the study.
- Have a negative pregnancy test at screening and before dosing (females only).
- Agree not to donate egg/sperm during participation in the study (from screening until the last follow-up visit).
- Are willing to provide a biopsy during the screening period (or provide a historic biopsy within 12 months prior to screening), and willingness to provide a biopsy at Week 16 of the study.
- Are taking certain medicines for type 2 diabetes (like metformin), you need to be on same dose for at least 12 weeks before screening. You also need to plan to take the same amount during the whole study.
You will not be elgibile to take part in this study if you:
- Have a medical history of any other illness, condition, or disease that in combination with the study drug would pose a risk to your safety.
- Have had weight change of ≥5%in the 12 weeks before screening, or since historic biopsy, if applicable.
- Cannot undergo liver biopsy, including if you are taking contraindicated medications, e.g., anticoagulants.
- Cannot undergo MRI or FibroScan®.
- Have Hepatitis B or C or Human Immunodeficiency Virus (HIV), or a chronic liver disease other than Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD).
- Have historic or current cirrhosis.
- Have a history of average alcohol consumption of greater than 2 units per day for women, and greater than 3 units per day for men within the past 6 months at screening.
- Have a diagnosis of type 1 or insulin-dependent type 2 diabetes.
- Have received or are going to receive another investigational medicine (within four weeks or five half-lives whichever is greater). Half-life is the amount of time it takes for the level of a medicine in your body to drop to half of its original amount.
- Test positive for drugs of abuse at screening.
- Have a history of organ transplant, other than a corneal transplant.
- Have cancer or history of cancer within the last 5 years (excluding some cancers).
- Have any serious medical condition, mental health problems, or take medicines that could make the study unsafe for you or make the results confusing.
- Are pregnant or breastfeeding.
Payment information
Participation is entirely voluntary, and you may withdraw from the study at any time without giving a reason.
In recognition of the time involved in taking part in the study, you will receive £5,075 on completion of the clinical study, provided you comply fully with all the clinical study requirements.
This amount is based on the anticipated clinical study plan and will be adjusted pro-rata (i.e. of money paid per unit of time), should we invite you to attend extra visits.
