Active not recruitingPHASE3INTERVENTIONAL

Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS - Extension Trial

This research is an ongoing study into a medication called glepaglutide for individuals living with Short Bowel Syndrome (SBS). It's an extension of a previous trial, meaning participants have already received this treatment. The main goal is to understand how safe glepaglutide is and how well it continues to work over a longer period, typically around two years. Participants will receive glepaglutide as a once-weekly injection under the skin. This study helps doctors learn more about the long-term effects of this treatment, which is important for managing SBS effectively and improving the quality of life for those affected.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Zealand Pharma

Enrolment target

129

Start

16 Jun 2021

Estimated completion

01 Apr 2026

Short Bowel Syndrome

What is this study about?

This study is a follow-up to an earlier trial and is looking at a medicine called glepaglutide, which is used for a condition called Short Bowel Syndrome (SBS). SBS happens when a large part of the small intestine is missing or doesn't work properly, making it hard for the body to absorb enough nutrients and water from food.

Glepaglutide is being tested to see if it's safe to use for a long time – about two years – and if it continues to help people with SBS absorb more nutrients. Participants in this study will receive the medicine as a simple injection under the skin once a week. This long-term information is really important because it helps doctors understand how best to manage SBS and support patients over many years.

By taking part, you'd be helping doctors learn more about how glepaglutide works over time. This knowledge can improve treatments for people with SBS in the future, helping them lead healthier, more comfortable lives.

Key takeaways

This study is for people already in a glepaglutide trial for Short Bowel Syndrome.
It checks the long-term safety and effectiveness of the medicine.
Glepaglutide is given as a weekly injection under the skin.
The study lasts for approximately two years.
Participants will receive regular medical check-ups.
It helps gather vital information for future SBS treatments.

Who may be eligible?

To be considered for this study, you must have already taken part in the previous EASE SBS 2 extension trial and completed all parts of it. This study is specifically for people who are continuing their treatment from that earlier trial.

There are also some important things that might mean you can't join. For example, if your doctor thinks you have any health issues that might make it unsafe for you to be in the study, or if it would make it hard to check how the treatment is working, you wouldn't be able to participate. Also, if you had a colonoscopy (a procedure to look at your bowel) at the end of the EASE SBS 2 trial and it showed any serious problems, or if you didn't have one when you should have, it might mean you can't join.

Additionally, if you're pregnant, breastfeeding, planning to get pregnant, or if you're a woman who could become pregnant and are not using effective contraception, you can't be in the study. You also can't have used certain other medications like GLP-1, GLP-2, or similar drugs in the last three months, though using glepaglutide in the earlier trial is fine.

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 have completed the full EASE SBS 2 extension trial.
My doctor believes it is safe for me to continue in the study.
I am not pregnant, breastfeeding, or planning to get pregnant, and if I can get pregnant, I'm using effective birth control.
I haven't used certain other similar medications in the last three months (other than glepaglutide in the previous trial).

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be given the study medicine, glepaglutide, as an injection under your skin, once a week. This treatment will continue for about two years. During this time, you will have regular visits with the study team. These visits will involve check-ups to see how you're doing, and to make sure the medicine is working as expected and isn't causing any problems. The team will also monitor your health closely throughout the two-year period. You'll have close medical supervision, and the study team will be there to answer your questions and support you.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is that you would continue to receive glepaglutide treatment, which could continue to help manage your Short Bowel Syndrome. However, there's no guarantee the treatment will work for everyone, and it might not work as well for you over time as it did initially. As with any medication, there could be side effects, which the study team will monitor closely. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (19)

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

Georgetown University Medical Center
Verified postcode
Washington D.C., United States
Mayo Clinic College of Medicin
Verified postcode
Rochester, United States
University of Nebraska Medical Center
Verified postcode
Omaha, United States
Vanderbilt University Medical Center, Nashville
Verified postcode
Nashville, United States
Universitair Ziekenhuis Leuven
Verified postcode
Leuven, Belgium
Rigshospitalet
Verified postcode
Copenhagen, Denmark
Hôpital Beaujon
Verified postcode
Clichy, France
Centre Hospitalier Lyon-Sud
Verified postcode
Pierre-Bénite, France
Charité - Universitätsmedizin Berlin
Verified postcode
Berlin, Germany
Universitätsklinikum Bonn
Verified postcode
Bonn, Germany
Universitätsklinikum Frankfurt
Verified postcode
Frankfurt, Germany
Asklepios Kliniken Hamburg GmbH
Verified postcode
Hamburg, Germany

Common questions

What is Short Bowel Syndrome (SBS)?

SBS is a condition where a significant part of the small intestine is missing or doesn't work well, making it hard for the body to absorb enough nutrients and water from food.

What is glepaglutide?

Glepaglutide is a medicine being tested to help people with Short Bowel Syndrome absorb more nutrients.

How is glepaglutide given in this study?

It's given as an injection just under the skin, once a week.

How long will I be in this study?

You will receive treatment and be monitored for about two years.

Why is this study important?

It helps doctors understand the long-term safety and effectiveness of glepaglutide, which can improve future treatments for people with SBS.