Clinical trial summary

We are conducting a clinical trial for a new investigational drug to determine if it may be safe and effective in the treatment of patients with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD or Non-Alcoholic Fatty Liver Disease (Part A) and Metabolic Dysfunction-Associated Steatohepatitis (MASH) (Part B). The trial drug is considered ‘investigational’ as it is not approved by any public health agency for any kind of treatment.

• We are recruiting male and female participants aged between:
• 18 to 55 years with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) or Non-Alcoholic Fatty Liver Disease (Part A), or 18 to 65 with Metabolic Dysfunction-Associated Steatohepatitis (MASH) (Part B).
• The intention of the trial is to study whether the investigational drug will reduce liver fat, liver injury, and liver scarring in patients with MASLD or Non-Alcoholic Fatty Liver Disease and MASH.
• The trial drug will be given as an injection under the skin.
• During the trial, you will undergo several clinical assessments that will help us evaluate the safety of the trial drug (safety), how well you tolerate the trial drug (tolerability), how the trial drug works to change the liver fat (pharmacodynamics), and how long the drug stays in your body (pharmacokinetics).

This clinical trial will be divided into two parts:

Part A: In Part A there will be up to 72 participants with MASLD or Non-Alcoholic Fatty Liver Disease. Each participant will receive a single dose of the study treatment. This part will involve a screening period, an in-patient period (during which you will receive the study treatment – trial drug or placebo) and an outpatient follow-up period.

Part B: In Part B there will be up to 28 participants with MASH. Each participant will receive two doses of the study treatment (12 weeks apart). This part will involve a screening period, a treatment period (during which you will receive two doses of the study treatment – trial drug or placebo) and a follow-up period.

If you are interested in taking part in Part A of this clinical trial:

• You will be required to attend 2 screening appointments so we can check if you are suitable to take part in the trial. At these appointments, we will perform several assessments, including but not limited to taking blood, checking your heart, carrying out a physical examination and liver scans.
• If results from your screening appointments show you are suitable for the trial, you will be asked to attend the in-house stay of 4 days / 3 nights in our clinical research unit.
• During your in-house stay, you will receive a single dose of the study treatment via an injection under the skin (subcutaneous). After your stay with us, you will be required to return for 7 follow-up visits over a period of 9 months after you receive the study treatment.
• This means the trial will take approximately 42 weeks from your initial screening visit through to your final visit.
• During the trial, we will conduct a number of assessments (like those we did at screening) to check how safe the trial drug is, how well you tolerate one dose of the trial drug, how long the drug remains in your body and how it affects your body.

If you are interested in taking part in Part B of this clinical trial:

• You will need to attend 3 screening appointments so we can check if you are suitable to take part in the trial. At these appointments, we will perform several assessments, including but not limited to taking blood, checking your heart, carrying out a physical examination and conducting scans of your liver. Eligible participants will also need to have a liver biopsy.
• If results from your screening appointments show you are suitable for the trial, you will be asked to undergo the treatment period where you will receive 2 doses of the study treatment 12 weeks apart. The study treatment will be given as an injection under the skin (subcutaneous).
• You will then be required to attend 5 follow-up visits over a period of 9 months.
• This means the trial will take approximately 58 weeks from your screening visit through to your final visit.
• During the trial, we will conduct a number of assessments (like those we did at screening) to check how safe the trial drug is, how well you tolerate multiple doses of the trial drug, how long the drug remains in your body and how it affects your body.