RecruitingPhase IInterventional

Evaluation of NBI-1117570 in adults with stable schizophrenia

This research is looking at a new medicine called NBI-1117570 for adults with schizophrenia who are currently stable. It's an early-stage study, meaning we're mainly checking if the medicine is safe and well-tolerated. We also want to understand how it works in the body and what effects it might have. Participants will take different doses of the medicine over time. The study aims to gather important information about NBI-1117570 before it can be tested in larger groups of people. Due to early approval from the Health Research Authority (HRA), the detailed results will be made public within 30 months after the study has ended, allowing time for thorough analysis.

At a glance

Status

Recruiting

Phase

Phase I

Sponsor

Neurocrine Biosciences (United States)

Enrolment target

Start

13 Apr 2026

Estimated completion

30 Sep 2027

Schizophrenia

What is this study about?

This study is about exploring a new medicine called NBI-1117570. It's being tested in adults who have schizophrenia and whose condition is currently steady and well-managed. The main aim is to understand how safe this new medicine is, how well people tolerate it, and what happens to it once it's in the body. This is an early-stage study, often called a 'Phase I' study, which means it's one of the first times this medicine is being given to people.

Researchers will be looking closely at how different doses of NBI-1117570 affect the body. Participants will receive the medicine, and doctors will carefully monitor them for any side effects and to see how their body processes the medicine. This kind of research is really important because it helps us learn if a new medicine could be a helpful treatment option in the future. It’s a necessary step before a medicine can move on to larger trials.

The detailed results of this study won't be immediately available. The Health Research Authority (HRA) has given permission for the full findings to be shared publicly within 30 months after the study has concluded. This extra time allows the research team to carefully analyse all the data and make sure everything is clearly presented.

Key takeaways

This study is testing a new medicine, NBI-1117570, for schizophrenia.
It's an early-stage study focused on safety and how the medicine works in the body.
Only adults aged 18-55 with stable schizophrenia can take part.
The full study details will be released in about two and a half years after it finishes.
You would receive close medical care if you participated.

Who may be eligible?

This study is looking for adults between 18 and 55 years old who have been diagnosed with schizophrenia and whose condition is currently stable. This means your symptoms are well managed, and you're not experiencing a period where your illness is particularly active or difficult.

Because this is an early-stage study, many of the specific rules about who can and cannot join haven't been shared publicly yet. Usually, these rules would make sure that participants are as similar as possible, so researchers can clearly see the effects of the new medicine.

Generally, when considering joining a trial like this, doctors would need to check things like your current health, any other medications you're taking, and if you have any other medical conditions. These details help ensure the study is safe for you and that the results will be accurate.

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 55 years old?
Have you been diagnosed with schizophrenia?
Is your schizophrenia currently stable and well-managed?
Are you willing to potentially take a new, untried medicine?
Are you able to attend regular appointments at a clinic?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be taking a new medicine called NBI-1117570. Exactly how many visits you'll need and for how long isn't yet public, but in similar early-stage studies, participants typically come to a clinic regularly for examinations, blood tests, and to receive their medication. You would likely start with a low dose, which would then be gradually increased over time (this is called 'intra-participant rising dose'). This allows the researchers to carefully monitor your reaction to different amounts of the medicine.

During your visits, you would have medical check-ups, potentially including body measurements, heart rate, blood pressure, and blood samples. These help the doctors understand how the medicine is affecting you. The total length of your participation is not yet disclosed, but these early studies often last several weeks to a few months. All details about your participation would be fully explained before you agree to join.

Potential risks and benefits

Taking part in any medical study has potential benefits and potential risks. A potential benefit of joining this study is that you would receive close medical attention and contribute to important scientific research that could help others with schizophrenia in the future. There's a chance the new medicine might help your symptoms, although this is not the main goal of this early study. Potential risks include experiencing side effects from the new medicine, which could range from mild to more serious. As this is an early-stage drug, not all side effects are fully known yet. You will be closely monitored by doctors and nurses to make sure you are safe. It's very important to know that you are free to stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Richmond Pharmacology Limited
City only
London, England

Common questions

What is the new medicine called?

The new medicine being tested in this study is called NBI-1117570.

What condition is this study for?

This study is for adults who have schizophrenia and whose condition is currently stable.

When will the full study results be available?

The full results of the study will be shared publicly within 30 months (about two and a half years) after the study has finished.

Is this medicine approved for general use?

No, NBI-1117570 is a new medicine still in the early stages of research and is not yet approved for general use.

What is the age range for participants?

Participants must be between 18 and 55 years old.

How to find out more

Clinical Development Lead

medinfo@neurocrine.com +1-877-641-3461 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.