A Clinical Trial to Learn About the Effects of VHB937 in People With Amyotrophic Lateral Sclerosis (ALS)

To be able to join this study, you need to be at least 18 years old. You must have a confirmed diagnosis of ALS from the study doctors, and your symptoms should have started within the last two years. The study is looking for people whose ALS symptoms are not yet severe, meaning you can still do most daily activities.

You might be suitable if you haven't started any treatment for ALS yet, or if you are already on an approved ALS treatment and your dose has been stable. You'll also need to be able to breathe out a reasonable amount of air, at least 60% of what is expected for someone your age, height, and gender.

However, some things would mean you can't join. For example, if you've recently taken part in another drug trial, have serious heart, liver, or kidney problems, or certain blood disorders, this study might not be right for you. Also, if you have other serious health conditions like certain cancers, uncontrolled diabetes, HIV, Hepatitis, or severe breathing difficulties, you might not be able to participate. The study team will carefully check all these details to make sure it's safe for you to take part.

If you decide to take part in this study, you will first go through some initial checks to see if you are suitable. If you are, you'll then be assigned to either receive VHB937 or a placebo – you won't know which one. You will take the study medication for about 40 weeks (around 10 months). During this time, you'll have regular visits to the study clinic for check-ups, where doctors will monitor your ALS symptoms, overall health, and any side effects. You'll likely fill out questionnaires about your daily activities and have breathing tests. After the main 40-week period, you may have the option to continue receiving VHB937 in an 'open-label extension' where everyone knows they are getting the active drug. The total duration of your involvement, including follow-up, will be clearly explained to you.