Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A 104-WEEK, MULTICENTER, SINGLE-ARM, LONG-TERM, PHASE 3 EXTENSION TRIAL INVESTIGATING THE SAFETY AND EFFICACY OF GLEPAGLUTIDE IN ADULT PATIENTS WITH SHORT BOWEL SYNDROME (SBS) COMPLETING THE EASE SBS 2 TRIAL

This research study is for adults living with short bowel syndrome (SBS) who have already taken part in a previous glepaglutide trial. The main goal is to understand the long-term safety of glepaglutide, meaning what side effects might happen and how often. Researchers will also be checking how well glepaglutide works over time. This includes looking at whether it helps reduce the amount of intravenous (IV) feeding and fluids people need, or if some can stop IV feeding altogether. This study aims to provide more information about glepaglutide as a potential treatment for SBS, helping to improve the lives of those affected by this condition.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Zealand Pharma A/S

Enrolment target

Start

10 Sep 2024

Short bowel syndrome

What is this study about?

This study is a continuation of previous research into a medicine called glepaglutide, designed for adults who have a serious condition called Short Bowel Syndrome (SBS). SBS means your body has trouble absorbing enough nutrients and fluids from food because a significant part of your small intestine is missing or doesn't work properly. Many people with SBS need nutrients and fluids delivered directly into their veins (this is often called IV feeding or parenteral support, PS) to stay healthy.

The main purpose of this study is to gather more long-term information about glepaglutide. Researchers want to carefully track any side effects people experience while taking the medicine. They also want to see if glepaglutide helps reduce the amount of IV feeding people need, or even helps them stop IV feeding completely. This is very important as reducing or stopping IV feeding can significantly improve quality of life for people with SBS. By understanding both the safety and effectiveness over a longer period, doctors can get a clearer picture of how glepaglutide might help patients.

This particular study is called a 'Phase 3 extension trial,' which means it builds on earlier research. Participants in this study have already taken glepaglutide in a previous trial, and this extension allows researchers to continue monitoring them over a longer time, up to about two years. This long-term look helps ensure the medicine is safe and effective when used over extended periods, which is crucial for managing a lifelong condition like SBS.

Key takeaways

This study investigates the long-term safety and effectiveness of glepaglutide for adults with Short Bowel Syndrome (SBS).
It's an extension study for people who previously took part in the EASE SBS 2 trial.
The main goals are to track side effects and see if glepaglutide reduces or stops the need for IV feeding.
Participants will receive regular injections of glepaglutide and have ongoing health checks for about two years.
The study aims to gather more information to help improve treatment for SBS patients.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, participants must be adults, meaning they are 18 years old or older. Both men and women can take part. A key requirement is that you must have previously completed an earlier study called the EASE SBS 2 trial with glepaglutide. This means you've already had experience with the study drug.

Since this is an extension study, it's designed specifically for those who have already participated in the first part of the research. This allows researchers to continue monitoring your health and the effects of the treatment over a longer period.

Other specific medical criteria, which your doctor will be able to explain, will also need to be met to ensure the study is safe and appropriate for you.

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.

I am 18 years old or older.
I have Short Bowel Syndrome (SBS).
I have already completed the EASE SBS 2 trial.
I am willing to attend regular clinic visits for about two years.

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will continue to receive the study medicine, glepaglutide, regularly, delivered as an injection. Throughout the study, you will have regular visits to the clinic. At these visits, the research team will carefully check your health. This will include taking your vital signs (like blood pressure and heart rate), performing physical examinations, and taking blood and urine samples to monitor your body's response to the medicine.

You will also be asked about any side effects you might be experiencing. The study aims to look at your health over about 104 weeks, which is roughly two years. The research team will track how your need for IV feeding might change over this period, whether it reduces or if you can stop it. You'll complete the study once the 104 weeks are up or if you decide to withdraw earlier.

Potential risks and benefits

Taking part in this study might offer potential benefits, such as continued access to glepaglutide, which could help reduce your need for IV feeding or even allow you to stop it. However, like all medicines, glepaglutide can have side effects, which the research team will closely monitor. There's also the chance the medicine may not work for everyone. 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
Denmark
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Unverified
Belgium
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Unverified
Germany
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Unverified
France
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Unverified
Netherlands
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Unverified
Poland

Common questions

What is glepaglutide?

Glepaglutide is a medicine being studied for short bowel syndrome that aims to help your body absorb more nutrients and fluids, potentially reducing your need for IV feeding.

What is Short Bowel Syndrome (SBS)?

SBS is a serious condition where your body has trouble absorbing nutrients from food, often because a large part of your small intestine is missing or doesn't work well. Many people with SBS rely on IV feeding.

How long will this study last?

This study is designed to last for about 104 weeks, which is roughly two years, to check the long-term effects of glepaglutide.

Will I have to pay to be in the study?

No, you will not have to pay for the study medicine or study-related assessments. Any travel expenses might be covered, but you should check this with the study team.

What if I want to stop taking part?

You are free to leave the study at any time, for any reason, without it affecting your usual medical care.