Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

SPI-62 as a Treatment for Hypercortisolism Related to a Benign Adrenal Tumor

This research study is investigating a new medication, SPI-62, for people who have too much of a hormone called cortisol in their body. This condition, called hypercortisolism, is caused by a non-cancerous (benign) growth on one of the adrenal glands, which are found above your kidneys. The study is in its early stages (Phase II) and aims to understand how well SPI-62 works and if it has any side effects, comparing these effects to the potential benefits. Researchers will be looking at various health markers, how the illness changes over time, and a range of symptoms linked to high cortisol, like blood sugar and blood pressure.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Sparrow Pharmaceuticals Inc., Sparrow Pharmaceuticals Inc.

Enrolment target

Start

07 Oct 2024

Hypercortisolism related to benign adrenal tumour

What is this study about?

This study is about a new possible treatment, called SPI-62, for a condition where your body makes too much of a hormone called cortisol. This often happens because of a non-cancerous (benign) lump on a small gland above your kidney, called an adrenal gland. Having too much cortisol can lead to various health problems.

The main aim of this study is to carefully look at how this new medicine, SPI-62, affects people. Researchers want to understand if it helps improve the condition and its symptoms, and also what side effects it might have. They will be checking things like blood test results and how healthy people feel overall. This information helps them decide if SPI-62 is a promising new treatment.

In the short-term, the study will check if symptoms related to high cortisol, such as high blood sugar, unhealthy fat levels in the blood, weaker bones, or high blood pressure, get better, worse, or stay the same. Over a longer time, they will also be carefully monitoring the overall safety of the medicine, looking for any serious health problems.

Key takeaways

This study is testing a new medicine (SPI-62) for high cortisol levels.
High cortisol is caused by a non-cancerous lump on your adrenal gland.
The study aims to check if SPI-62 is safe and helps improve symptoms.
It's in an early stage (Phase II) of research.
Adults aged 18 and over can be considered for participation.
Taking part means trying a new medicine and having regular health checks.

Who may be eligible?

To take part in this study, you need to be an adult, 18 years old or older. There is no upper age limit, so people of all adult ages are welcome to be considered.

This study is for both men and women. The researchers are looking for a wide range of people to make sure the results apply to many different individuals.

The most important thing is that you have hypercortisolism, which means your body is making too much cortisol, and that this is caused by a non-cancerous growth on your adrenal gland. More detailed health checks will be done by the study team to see if you are a good fit.

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 have hypercortisolism (high cortisol)?
Is your high cortisol caused by a non-cancerous growth on your adrenal gland?
Are you able to attend regular study appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be trying a new medicine called SPI-62. This isn't a final approved treatment yet, so you'll be helping researchers understand how it works. You would have regular visits to the study clinic where the team will take blood samples, measure your blood pressure, and ask about your symptoms and how you are feeling. They will keep a close eye on your health and any changes. The study will involve taking the medication and attending these follow-up appointments for a period of time to track your progress and any side effects. The exact number of visits and the full length of the study would be explained to you in detail by the study team.

Potential risks and benefits

Taking part in a study like this might have potential benefits, such as receiving a new treatment that could improve your condition, or getting extra health monitoring. However, there are also potential risks, as any new medicine can cause side effects that aren't fully known yet. You will be closely monitored for any problems. It's very important to remember that joining a study is always your choice, and you are free to withdraw at any time without giving a reason, and it won't affect your usual medical care.

Locations (1)

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

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Unverified
Romania

Common questions

What is hypercortisolism?

It's a condition where your body has too much of the hormone cortisol, often caused by a growth on your adrenal gland.

What is SPI-62?

It's a new medicine being tested to see if it can help people with high cortisol levels.

Is this medicine approved for general use?

No, it's still in the testing phase (Phase II), meaning we are learning about its effects and safety.

What does 'benign adrenal tumour' mean?

It means a non-cancerous growth on the gland above your kidney that produces hormones.

Who can join this study?

Adults aged 18 and over who have hypercortisolism caused by a non-cancerous adrenal growth.