A randomized, double-blind, placebo-controlled, single-ascending-dose study in healthy volunteers and a double-blind, placebo-controlled, multiple-ascending-dose study in patients with Parkinson’s disease to evaluate the safety, tolerability, and PK/PD of LY3962681.
This research study is looking at a new potential medicine called LY3962681. The main goal is to find out if this medicine is safe for people to take and to understand any side effects it might cause. Researchers also want to learn how the medicine behaves in the body, such as how long it stays there and what effects it has. The study will happen in two stages. First, a small dose will be given to healthy volunteers to check its safety. Then, people with Parkinson's disease will receive different doses to see how they react. This is a very early stage of testing, helping us understand more about this new treatment for Parkinson's disease.
At a glance
What is this study about?
This study is about a new medicine, which we'll call LY3962681, that could potentially help people with Parkinson's disease. When scientists develop a new medicine, they need to test it very carefully to make sure it's safe and that it works the way they expect.
The first part of this study involves giving a single dose of LY3962681 to healthy volunteers. This is an important step to see if the medicine is well-tolerated and if there are any immediate side effects in people who don't already have a health condition. It helps researchers understand how the medicine behaves in the human body for the very first time.
Once they have a better understanding of its effects in healthy people, the study will move on to people who have Parkinson's disease. In this stage, participants will receive multiple doses of the medicine over a period. This helps researchers learn more about how the medicine works in people with the condition, including how effective it might be and if there are any side effects when taken regularly. All of this information is vital for deciding if the medicine should be tested further in larger studies.
Key takeaways
- This study is testing a brand-new medicine, LY3962681, for Parkinson's disease.
- It's a very early stage (Phase 1) trial, focused on safety and how the medicine acts in the body.
- The study involves both healthy volunteers and people with Parkinson's disease.
- Participants will receive either the study medicine or a placebo, without knowing which.
- You can stop participating at any time.
- Your involvement helps to find future treatments for Parkinson's.
Who may be eligible?
To be considered for this study, you must be 18 years old or older. The study is open to both men and women.
Initially, the study will be looking for healthy volunteers. This means people who generally don't have any major health problems, especially not Parkinson's disease.
After that first phase, the study will then look for people who have been diagnosed with Parkinson's disease. Specific details about how long you've had Parkinson's or what medicines you're currently taking will be shared by the study team, as these can be very important details.
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 18 years old or older?
- Do you generally consider yourself healthy (for the first part of the study)?
- Have you been diagnosed with Parkinson's disease (for the second part of the study)?
- Are you able to attend regular clinic visits?
- Are you willing to potentially receive a placebo instead of the active medicine?
What does participation involve?
If you decide to take part in this study, you would first have a screening visit to make sure you meet all the requirements. If you are suitable, you would then attend several visits to the study clinic. These visits might include physical examinations, blood tests, and other assessments to check your health and how your body is reacting to the medicine.
During your visits, you would either receive the new study medicine, LY3962681, or a placebo. A placebo looks like the real medicine but contains no active ingredients. This is a common way to test new medicines fairly. Neither you nor the study team will know if you are receiving the medicine or the placebo. The total duration of your participation, including follow-up appointments after you stop taking the medicine, will be explained in detail by the study team.
Potential risks and benefits
Locations (2)
- —UnverifiedGermany
- —UnverifiedNetherlands
Common questions
What is Parkinson's disease?
Parkinson's disease is a condition that affects the brain, causing problems with movement like shaking, stiffness, and difficulty with balance and coordination.
What does 'double-blind' mean in a study?
Double-blind means that neither you (the participant) nor the study doctors will know if you are receiving the new medicine or a dummy medicine (placebo). This helps make the study fair.
What is a 'placebo'?
A placebo is a substance that looks exactly like the study medicine but contains no active drug. It helps researchers compare the effects of the new medicine against no treatment.
What is 'Phase 1' of a drug trial?
Phase 1 is the first time a new medicine is given to humans. It's mainly to check if it's safe, what dose is safe, and how the body handles it, usually in a small group of people.
Will I get paid for taking part?
The study team will provide full details about any reimbursement for travel or time spent, or if there is no payment involved. You should ask about this.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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