Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A DOUBLE-BLIND PHASE 3 EXTENSION TRIAL ASSESSING THE LONG TERM SAFETY AND EFFICACY OF GLEPAGLUTIDE IN PATIENTS WITH SHORT BOWEL SYNDROME (SBS)

This long-term study is for adults with Short Bowel Syndrome (SBS) and is testing a medicine called glepaglutide. SBS is a condition where your body can't absorb enough nutrients because part of your small intestine is missing or not working well. Often, people with SBS need extra nutrition given through a drip, called parenteral support (PS). This study aims to find out how safe glepaglutide is and if it can help people reduce their need for PS. Participants will either receive glepaglutide or a placebo (a dummy medicine) without knowing which one they are getting. Researchers will check for side effects and measure if glepaglutide helps people spend less time on PS or even stop it altogether.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Zealand Pharma A/S

Enrolment target

Start

13 Nov 2024

Short Bowel Syndrome

What is this study about?

This research is looking at a new treatment called glepaglutide for a condition known as Short Bowel Syndrome, often shortened to SBS. SBS is a serious digestive problem that happens when a large part of the small intestine is missing or not working as it should. This can be due to surgery or an illness. Because the small intestine is so important for absorbing food and drink, people with SBS often can't get enough nutrients from their diet alone. This means they often need extra nutrition and fluids given directly into their bloodstream using a drip, which is called parenteral support (PS).

This particular study is a long-term 'Phase 3' trial, which means it's one of the final steps before a medicine might be made available to everyone. The main goals are to carefully check how safe glepaglutide is for people to use over an extended period. Researchers will be looking out for any side effects and serious health issues. They also want to see how well glepaglutide works, specifically if it can help people reduce the amount of PS they need each week, or even stop using it entirely.

To make sure the results are reliable, some participants will receive the active medicine (glepaglutide), while others will get a placebo (a dummy medicine that looks the same but contains no active drug). Neither the patients nor their doctors will know who is getting which, which helps prevent bias. This helps scientists understand if any changes are truly due to the glepaglutide. They will regularly check things like vital signs, blood tests, and urine tests to monitor participants' health throughout the study.

Key takeaways

This study is testing a new medicine called glepaglutide for adults with Short Bowel Syndrome (SBS).
The main goal is to see how safe the medicine is over a long time and if it helps reduce the need for intravenous feeding (parenteral support).
Participants will receive either glepaglutide or a dummy medicine, without knowing which one.
Experts will regularly check health, blood tests, and how much intravenous feeding is needed.
Potential benefits include a chance to reduce reliance on intravenous feeding, but there are also potential risks like side effects.

Who may be eligible?

To be able to take part in this study, you need to be an adult, aged 18 years or older, with Short Bowel Syndrome (SBS).

Both men and women can join this study. The researchers are looking for people who are currently needing parenteral support (PS) because of their SBS.

There will be other, more detailed health requirements that your doctor would need to check to make sure the study is a good fit for you and safe for your specific situation. This could include aspects of your general health, other medications you are taking, and how severe your SBS is.

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 Short Bowel Syndrome (SBS)?
Do you currently rely on intravenous feeding (parenteral support) for your nutrition?
Are you able to attend regular clinic appointments for the duration of the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it would involve regular visits to the study clinic. During these visits, the medical team would give you the study medicine (either glepaglutide or the placebo) and perform various health checks. These checks would include monitoring your vital signs, taking blood and urine samples, and possibly performing heart tracings (ECGs) to make sure you are tolerating the treatment well. Researchers will also closely track your use of parenteral support, looking at how much you need and for how many days each week.

Over time, they will assess if there are any changes in your need for PS, your body weight, and your overall health. The exact number of visits and the full duration of your participation would be explained in detail by the study team, but as it's a long-term study, it would likely involve many months of active participation and follow-up.

Potential risks and benefits

Taking part in a clinical trial offers the chance to try a new medicine that isn't widely available yet, which might help reduce your need for parenteral support. However, there's no guarantee the medicine will work, and you might receive a placebo. There's also a chance you could experience side effects from the study medicine, some of which might be unpleasant or, in rare cases, serious. The medical team will regularly monitor your health very closely to identify any potential issues early. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

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

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Unverified
France
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Unverified
Belgium
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Unverified
Germany
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Unverified
Netherlands
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Unverified
Poland

Common questions

What is Short Bowel Syndrome (SBS)?

It's a condition where your small intestine can't absorb enough nutrients, often after surgery or illness, leading to the need for special feeding.

What is parenteral support (PS)?

This is extra nutrition and fluids given directly into your bloodstream through a drip when you can't get enough from eating and drinking.

What does 'double-blind' mean?

It means neither you nor your study doctor will know whether you're receiving the actual medicine or a dummy medicine (placebo).

Will I have to stop my current SBS treatment?

The study team will discuss all your current treatments with you to determine if you can safely participate without altering your existing care unnecessarily.

What are 'side effects'?

These are any unwanted or unexpected effects that might happen as a result of taking the study medicine. They will be carefully monitored.