Efficacy and Safety Evaluation of Glepaglutide in Treatment of Short Bowel Syndrome
This study is designed for adult patients who have Short Bowel Syndrome (SBS) and are currently receiving a medication called Glepaglutide as part of previous studies (EASE SBS 2 or EASE SBS 3). The main goal is to understand the long-term safety and effectiveness of taking Glepaglutide 10 mg twice a week. Participants will continue their treatment for two years, followed by a four-week safety check period. Throughout this time, you'll have regular hospital visits for various health checks, such as heart tests, blood and urine tests, and physical examinations. This is an 'extension' study, meaning it allows patients who are already doing well on the medication to continue receiving it and helps researchers gather more information about its long-term effects.
At a glance
What is this study about?
This research study is looking at a medication called Glepaglutide for adults who have a condition called Short Bowel Syndrome (SBS). SBS means your body has trouble absorbing enough nutrients from food because a large part of your small intestine is missing or doesn’t work properly. This study is an 'extension' of two earlier studies (EASE SBS 2 and EASE SBS 3), which means it allows people who are already taking Glepaglutide and benefiting from it to continue their treatment. The main aim is to understand the long-term safety of Glepaglutide and how well it continues to help over a longer period.
The study involves taking 10 mg of Glepaglutide twice a week. Researchers will closely monitor participants for two years to see if the medication is still safe and effective. They will also keep track of any side effects. This kind of long-term study is very important because it helps doctors and patients understand how a medication works over time, not just for a few months.
By continuing to study Glepaglutide, researchers hope to gather more complete information about its benefits and any potential risks when used for an extended period. This can help improve care for people with Short Bowel Syndrome in the future.
Key takeaways
- This study is for adults with Short Bowel Syndrome already taking Glepaglutide.
- It allows you to continue your current Glepaglutide treatment (10 mg, twice weekly).
- It aims to understand the long-term safety and how well Glepaglutide works over two years.
- You'll have regular health checks, including heart tests and blood tests.
- You can stop participating at any point if you choose.
Who may be eligible?
To join this study, you must be an adult aged 18 or older. A key requirement is that you are already participating in one of the previous Glepaglutide studies for Short Bowel Syndrome, either EASE SBS 2 (and have taken Glepaglutide for at least 6 months) or EASE SBS 3, and are currently receiving treatment.
There are certain reasons why you wouldn't be able to join. For example, if your doctor believes this study might put your health at risk, or if you've already had serious side effects from Glepaglutide that caused you to stop taking it in the previous studies. Also, if you're taking other specific medications that interfere with how Glepaglutide works, you wouldn't be able to join. If you are pregnant, breastfeeding, or planning to become pregnant, you cannot take part.
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?
- Are you currently receiving Glepaglutide in the EASE SBS 2 (for at least 6 months) or EASE SBS 3 study?
- Are you NOT pregnant, breastfeeding, or planning to become pregnant?
- Are you NOT taking other specific medications like GLP-1, GLP-2 (e.g., teduglutide), HGH, or DPP-4 inhibitors?
- Do you feel generally well enough to attend regular clinic visits?
What does participation involve?
If you decide to join this study, you will continue to receive Glepaglutide 10 mg twice a week, just as you have been in your previous study. The treatment period will last for two years (104 weeks). During these two years, you will need to attend regular visits to the study clinic or hospital. These visits will involve various health checks to monitor your progress and safety.
These checks may include heart tests (like an ECG), measuring your blood pressure and pulse, having blood and urine samples taken, and a general physical examination by the study doctor. You might also have a colonoscopy, which is a procedure to look inside your bowel. After the two-year treatment period, there will be a final four-week safety check-up period to make sure everything is alright.
Throughout the study, you'll be closely supported by the study team. Remember, your participation is voluntary, and you can withdraw at any time.
Potential risks and benefits
Locations (16)
- Mayo Clinic - PPDSVerified postcodeRochester, United States
- Lied Transplant Center at Nebraska Medical CenterVerified postcodeOmaha, United States
- Cleveland Clinic-9500 Euclid AveVerified postcodeCleveland, United States
- Vanderbilt University Medical Center-Tennesse-1211 21st Ave SVerified postcodeNashville, United States
- UZ Leuven - PPDSVerified postcodeLeuven, Belgium
- LHSC - University HospitalVerified postcodeLondon, Canada
- AP-HP - Hôpital BeaujonVerified postcodeClichy, France
- Universitätsklinikum FrankfurtVerified postcodeFrankfurt am Main, Germany
- Universitätsmedizin RostockVerified postcodeRostock, Germany
- Universitätsklinikum BonnVerified postcodeBonn, Germany
- Charité - Universitätsmedizin BerlinVerified postcodeBerlin, Germany
- Asklepios Klinik St. GeorgVerified postcodeHamburg, Germany
Common questions
What is Glepaglutide?
Glepaglutide is a medication being studied for people with Short Bowel Syndrome to help their body absorb nutrients better.
Why is this study happening?
This study allows patients already on Glepaglutide in previous trials to continue their treatment and helps researchers understand its long-term safety and effectiveness.
How long will I be in the study?
You'll be on treatment for about two years, followed by a short safety check-up period of four weeks.
Will I have to pay to be in the study?
No, all study-related treatments and tests are provided at no cost to you.
What if I want to stop taking part?
You can leave the study at any time, for any reason, and it won't affect your regular medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.