Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Randomized, Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Paltusotine in Subjects with Acromegaly Treated with Long-acting Somatostatin Receptor Ligands

This research study is for people in the UK who have acromegaly and are currently being treated with long-acting injections to help manage their hormone levels. The study is testing a new tablet medicine called paltusotine. Researchers want to find out if paltusotine is safe and if it can effectively keep key hormones, like IGF-1, at healthy levels. This is a "Phase III" study, which means it's a major step before a new medicine might become widely available. Participants will either receive the new tablet or a dummy tablet (placebo), and doctors will carefully monitor their hormone levels and symptoms to see how well the new medicine works compared to not taking it.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Crinetics Pharmaceuticals Inc.

Enrolment target

Start

11 Sep 2024

Acromegaly

What is this study about?

This clinical trial is designed for people living with acromegaly, a condition caused by a benign (non-cancerous) growth in the pituitary gland, a small gland at the base of your brain. This growth leads to your body producing too much growth hormone. This can cause various health problems over time, like enlarged hands and feet, headaches, and other issues. Many people with acromegaly currently manage their condition with long-acting injections, which help to control hormone levels.

Researchers are testing a new tablet medicine called paltusotine. The main goal is to see if this tablet can help keep important hormone levels (specifically one called IGF-1) within a healthy range. They also want to understand if it helps with other symptoms of acromegaly. If this new tablet works well, it could potentially offer a more convenient treatment option for people who currently rely on injections.

This is a "Phase III" study, which means it's a large and important step in the development of a new medicine. It will compare paltusotine with a placebo (a dummy tablet that looks the same but has no medicine in it) to clearly see the effects of the new drug. Doctors will be checking to see how many people on paltusotine can maintain good hormone control compared to those on the placebo, and they will also look at changes in other hormones and how people feel.

Key takeaways

This study is for adults with acromegaly already on injectible treatment.
It tests a new tablet, paltusotine, to see if it can keep hormone levels normal.
Participants will receive either paltusotine or a dummy tablet.
You'll have regular clinic visits, blood tests, and health checks.
The study aims to find a potentially simpler treatment option for acromegaly.
You can stop participating at any time.

Who may be eligible?

This study is open to adults aged 18 and older. Both men and women can take part. To be eligible, you must have acromegaly and be currently stable on long-acting somatostatin receptor ligands (the medical term for the type of injection you might be receiving for your acromegaly).

There will be other, more detailed criteria that the study team will discuss with you. These might include specific hormone levels, overall health, and any other medications you are taking. It's important to discuss your full medical history with the study doctor to see if this trial is right for you.

Even if you meet the initial age and condition requirements, the study team will need to do thorough checks to ensure your safety and that the trial results will be accurate. They will explain all the requirements clearly.

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 a diagnosis of acromegaly?
Are you currently receiving long-acting injections for your acromegaly?
Are you generally feeling stable on your current acromegaly treatment?

Answer every question to see your result.

What does participation involve?

Taking part in this study means you'll have regular visits to a clinic. During these visits, doctors and nurses will check your health, take blood and urine samples, and ask you about your symptoms. You will be given either the new paltusotine tablet or a placebo tablet to take, and you won't know which one you're receiving. This is called a 'blinded' study, which helps to ensure fair results. The study will likely last for several months, with an initial main 'randomized control phase' where you'll receive either the drug or placebo.

You will need to attend appointments, which might involve travel. The doctors will monitor your hormone levels very carefully. You might also be asked to keep a diary of your symptoms. After the main comparison phase, there might be an option to continue taking the active paltusotine tablet in an 'open-label' phase, where everyone knows what treatment they are getting. The study team will explain the full schedule of visits and what each visit involves before you decide to join.

Potential risks and benefits

Participating in a clinical trial offers the potential benefit of accessing a new treatment before it's widely available, which might improve your condition. However, there are potential risks, just like with any medicine. The new tablet might cause side effects, which you would be carefully monitored for. There's also no guarantee that the tablet will work for you, especially if you receive the placebo, but you will still be closely monitored by medical professionals. Participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (6)

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

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Unverified
Belgium
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Unverified
France
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Unverified
Hungary
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Unverified
Bulgaria
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Unverified
Poland
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Unverified
Italy

Common questions

What is acromegaly?

Acromegaly is a condition where your body produces too much growth hormone, usually due to a small growth in your pituitary gland. This can cause parts of your body to grow larger than normal and lead to other health problems.

What is paltusotine?

Paltusotine is a new medicine being tested as a tablet for acromegaly. It aims to help control the growth hormone levels in your body.

What does 'Phase III' mean?

Phase III means this is a large study comparing the new medicine to either a standard treatment or a placebo. It's a key step to see if the medicine is safe and effective enough to be considered for wider use.

Will I know if I'm getting the real medicine or a dummy pill?

No, during the main part of the study, neither you nor your doctors will know if you're taking paltusotine or a dummy pill (placebo). This helps ensure fair and accurate results.

Can I stop participating in the study if I want to?

Yes, absolutely. Your participation is completely voluntary, and you can withdraw from the study at any time without having to give a reason, and it won't affect your future medical care.