Active not recruitingPHASE3INTERVENTIONAL

Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS

This study is a long-term look at glepaglutide, a new medicine for people who have a condition called Short Bowel Syndrome (SBS). SBS means your body has trouble absorbing enough nutrients from food because a part of your small intestine is missing or doesn’t work well. The main goal of this research is to understand the long-term safety of glepaglutide. Researchers also want to see how effective it is in helping people manage their SBS symptoms over a longer period. Participants in this study would have already taken part in a previous study of glepaglutide. This study hopes to gather important information to help improve treatments for people living with SBS.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Zealand Pharma

Enrolment target

145

Start

07 May 2019

Estimated completion

01 Apr 2026

Short Bowel Syndrome

What is this study about?

This research study is focused on a new medicine called glepaglutide, and how it might help people who have a condition called Short Bowel Syndrome (SBS). SBS happens when a large part of the small intestine is either missing or not working properly. This can make it very hard for your body to absorb enough water, vitamins, and nutrients from the food you eat, often leading to tummy problems and needing extra support like drips.

The main purpose of this study is to carefully watch what happens when people with SBS take glepaglutide over a long time. The doctors and researchers want to make sure it's safe and to see how well it continues to help their symptoms. They hope that glepaglutide could offer a new way to improve the quality of life for people with SBS, helping them to feel better and absorb more nutrients naturally.

By understanding the long-term effects of glepaglutide, this study aims to build on previous research and gather more complete information. This information is vital for healthcare professionals to make informed decisions about the best ways to treat SBS in the future and potentially help many individuals living with this challenging condition.

Key takeaways

This study looks at the long-term safety and effectiveness of glepaglutide for Short Bowel Syndrome (SBS).
It's for people who have already completed an earlier glepaglutide study.
The goal is to improve treatment options for SBS patients.
Participation involves continued use of the medicine and regular health check-ups.
The study focuses on understanding effects over a longer period.

Who may be eligible?

To be able to join this study, you must have already taken part in an earlier study for glepaglutide (either study ZP1848-17111 or study ZP1848-15073) and completed it. You also need to be at least 18 years old, but no older than 90 years old.

There are some reasons why you might not be able to join. For example, if you decided not to continue with the previous glepaglutide study, you wouldn't be eligible. Also, if a doctor thinks that taking part in this new study might put your health at risk, or make it hard for the study to get accurate results, then you wouldn't be able to join.

Women who could become pregnant, or are pregnant or breastfeeding, cannot take part unless they are using very effective birth control methods. Also, if you have recently (in the last 3 months) used certain other medicines that affect your gut hormones, like GLP-1 or GLP-2 medicines, or growth hormone, you wouldn't be able to join this particular study.

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.

Did you complete an earlier glepaglutide study?
Are you between 18 and 90 years old?
Are you free from conditions that might make participating unsafe or complicate results?
If you are a woman who could become pregnant, are you using highly effective contraception and are not pregnant or breastfeeding?
Have you avoided certain other gut hormone medicines in the last 3 months?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be continuing to use glepaglutide, as you would have done in the previous study. The exact details of how often you'd need to visit the clinic and what tests or assessments might be involved would be explained fully by the study team. Usually, these long-term studies involve regular check-ups to monitor your health, how the medicine is affecting your body, and to record any side effects. You'll likely have blood tests and other assessments at these visits. The study team will make sure you understand the schedule and what's expected of you throughout the entire duration of your participation.

Potential risks and benefits

Participating in this study might offer you continued access to a new treatment for Short Bowel Syndrome that could help manage your condition. Doctors will closely monitor your health, which means you'll receive regular medical attention. However, like all medicines, glepaglutide can have side effects, and some may not yet be fully known, especially with long-term use. There's also the chance the treatment might not work as well for you or could cause discomfort. You are always free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (27)

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
University of Chicago Children's Hospital
Verified postcode
Chicago, United States
Mayo Clinic College of Medicine
Verified postcode
Rochester, United States
University of Nebraska Medical Center
Verified postcode
Omaha, United States
Mount Sinai Hospital
Verified postcode
New York, United States
Cleveland Clinic
Verified postcode
Cleveland, United States
Vanderbilt University Medical Center, Nashville
Verified postcode
Nashville, United States
UZ Leuven
Verified postcode
Leuven, Belgium
The Royal Alexandra Hospital
Verified postcode
Edmonton, Canada
Western University
Verified postcode
London, Canada
University Health Network - Toronto General Hospital
Verified postcode
Toronto, Canada
Rigshospitalet
Verified postcode
Copenhagen, Denmark

Common questions

What is Short Bowel Syndrome (SBS)?

SBS is a serious condition where your body has trouble absorbing enough nutrients and water from food because a significant part of your small intestine is either removed or not working properly.

What is glepaglutide?

Glepaglutide is the name of the medicine being studied. It's designed to help people with Short Bowel Syndrome absorb more nutrients.

Why is this study being done?

This study wants to learn more about how safe glepaglutide is over a long time and how well it helps people with SBS manage their condition for longer periods.

Who can join this study?

You can join if you've already completed a previous glepaglutide study and are an adult between 18 and 90 years old. There are also other specific health requirements.

What will happen if I join?

You will continue to receive glepaglutide, and the study team will monitor your health and how the medicine affects you through regular visits and assessments.