SPI-62 as a Treatment for Adrenocorticotropic Hormone- dependent Cushing’s Syndrome
This research study is testing a new medication, SPI-62, for people with a specific type of Cushing's Syndrome called ACTH-dependent Cushing’s Syndrome. Cushing’s Syndrome happens when your body makes too much of a hormone called cortisol, which can cause various health problems. This study is in an early stage (Phase 2), meaning it’s one of the first times this medication has been tried in a larger group of people. Researchers want to see if SPI-62 helps to balance hormone levels, improve symptoms, and how safe it is. They will be closely monitoring participants' health and well-being throughout the study.
At a glance
What is this study about?
This study is about a new treatment called SPI-62 for a condition known as Cushing's Syndrome. Specifically, it's for people who have 'ACTH-dependent' Cushing's Syndrome, which means the issue starts with another hormone called ACTH telling your body to make too much cortisol. Having too much cortisol can lead to various health problems, including weight gain, high blood pressure, and weakened bones.
The main aim of this study is to see how SPI-62 affects certain hormone levels in your body, especially those related to cortisol, after six weeks of treatment. This will give doctors an idea of whether the medication is working as intended. They will measure specific substances in your urine that reflect how your body is handling cortisol. This study is in an early phase of testing (Phase 2), which means researchers are trying to find out if the treatment is effective and safe before it can be widely used.
Beyond checking hormone levels, the study will also keep a close eye on your overall health. This includes looking at common things like blood tests, heart health (using ECGs), blood sugar levels, and your general well-being. Researchers will also be interested in how the medication might affect your weight, muscles, bones, and even mood and sleep, as these can all be impacted by Cushing's Syndrome. This detailed approach helps them understand the full picture of how the new medication affects your body.
Key takeaways
- This study is testing a new medication, SPI-62, for Cushing's Syndrome.
- It aims to see if SPI-62 can help balance hormone levels and improve symptoms.
- Participants will have regular health checks, including blood tests and physical exams.
- The study is in an early stage (Phase 2) to evaluate both effectiveness and safety.
- Both men and women aged 18 and older can be considered for participation.
Who may be eligible?
To be considered for this study, participants must be at least 18 years old. There's no upper age limit, meaning older adults can also take part.
Both men and women are welcome to participate in this research. The study needs a diverse group of people to understand how the medication works across different individuals.
Specific medical details define who can join, which will be discussed in full with your doctor. These details ensure the safety of participants and the accuracy of the study results. Your doctor can help you understand if your medical history fits the study's requirements.
- Are you at least 18 years old?
- Do you have ACTH-dependent Cushing's Syndrome?
- Are you able to attend regular clinic appointments?
- Are you willing to take a new study medication?
- Are you open to having various health checks, including blood and urine tests?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you join this study, you'll be taking the medication SPI-62 for a period of time. You'll have regular visits to the clinic, where doctors and nurses will check your health. These visits will involve various tests, such as blood and urine samples, to measure hormone levels and other health markers. You might also have heart checks (ECGs), blood pressure readings, and potentially tests to monitor your blood sugar continuously. Some visits might include physical examinations, questions about your symptoms, mood, and sleep, and tests to measure your muscle strength.
Initially, closely monitored checks will be carried out over 12 weeks. If you continue in the 'open-label extension phase,' you will receive continuous treatment and monitoring for a longer period. The specific number of visits and the exact tests performed will be explained in detail by the study team, but they are designed to safely track your progress and how the medication affects you.
Potential risks and benefits
Locations (2)
- —Bulgaria
- —Romania
Common questions
What is Cushing's Syndrome?
Cushing's Syndrome is a health condition caused by too much cortisol, a stress hormone, in your body. It can lead to various symptoms like weight gain, high blood pressure, and muscle weakness.
What is SPI-62?
SPI-62 is the name of the new medication being tested in this study. It's designed to help manage the hormone imbalances seen in Cushing's Syndrome.
What is a 'Phase 2' trial?
A Phase 2 trial means the medication has passed initial safety checks and is now being tested in a larger group of people to see how well it works and to further assess its safety.
Will I know if I'm getting the active drug?
The study design will determine if participants know which treatment they are receiving. The researchers will explain this to you clearly at the beginning.
How long will I be in the study?
The initial part of the study involves 12 weeks of treatment and monitoring, with an option to continue into a longer-term open-label extension phase, which means continuous treatment and monitoring for a longer period.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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