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A Study to Evaluate the Long-Term Safety of Glepaglutide in Adult Patients with Short Bowel Syndrome Who Participated in Previous Studies

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What is this study about?

This clinical trial is studying short bowel syndrome, a condition where part of the small intestine is missing or not working properly, which makes it difficult for the body to absorb enough nutrients and fluids from food. The treatment being studied is glepaglutide, which is given as an injection under the skin. Glepaglutide is a synthetic peptide, which means it is a manufactured protein-like substance designed to help the remaining intestine work better and absorb more nutrients.

The purpose of this study is to evaluate the safety and how well glepaglutide works over a longer period of time in adults with short bowel syndrome who have already been taking this medicine in previous studies. The study will last for 104 weeks, which is about two years, and patients will receive glepaglutide injections twice a week at a dose of 10 milligrams. This is an extension study, meaning it is designed for patients who are already being treated with glepaglutide in earlier trials and want to continue receiving the medicine.

During the study, doctors will monitor patients regularly to check for any unwanted effects and to see if the medicine continues to help reduce the amount of nutritional support that patients need through their veins, which is called parenteral support. The study will track changes in the weekly amount of parenteral support that patients require from the beginning of the study until the end of treatment at 24 months. All patients in this study will receive glepaglutide, and there is no placebo group in this trial.

1 Enrollment and baseline assessment

Upon joining this extension trial, your baseline measurements will be recorded at Visit 1. This serves as the starting point for tracking your progress throughout the trial.

The trial is designed for patients who have already been receiving glepaglutide treatment in previous trials and are continuing with this medication.

2 Treatment period with glepaglutide

You will receive glepaglutide 10 mg administered twice weekly (TW) throughout the trial period.

The medication is provided as a solution for injection at a concentration of 20.0 mg per milliliter.

The treatment is administered via subcutaneous injection, which means the medication is injected under the skin.

This treatment period will continue for 104 weeks, which is approximately 2 years or 24 months.

3 Regular monitoring visits

Throughout the trial, you will attend scheduled visits at the trial site for monitoring and assessment.

During these visits, your safety and how well the treatment is working will be evaluated.

Your prescribed weekly volume of parenteral support (PS) will be monitored. Parenteral support refers to nutrition that is delivered directly into the bloodstream through an intravenous line, bypassing the digestive system.

Any treatment-emergent adverse events (TEAEs) will be recorded. These are any new medical problems or worsening of existing conditions that occur during the treatment period.

4 End of treatment assessment

At the end of the 24-month treatment period, a final assessment will be conducted at the end of treatment visit (EOT).

Your prescribed weekly parenteral support volume will be compared to the baseline measurement taken at the beginning of the trial.

A comprehensive evaluation of your overall response to the treatment will be performed.

5 Safety follow-up visit

After completing the treatment period, you will attend a safety follow-up visit.

This visit allows for continued monitoring of any treatment-emergent adverse events that may have occurred during the trial.

This final safety check ensures that any ongoing medical issues are properly documented and addressed.

Who Can Join the Study?

  • You must have signed a consent form, which is a document showing you agree to take part in the study, and you must be willing to follow all study rules and requirements.
  • You must be currently receiving treatment and have already completed at least 6 months of treatment with glepaglutide, which is the study medicine, in a previous study called EASE SBS 2, or you must be currently receiving treatment in another study called EASE SBS 3.

Who Cannot Join the Study?

  • The source data does not contain specific exclusion criteria (reasons why a patient cannot participate in this study)
  • Without detailed exclusion criteria information, it is not possible to list the specific conditions or situations that would prevent participation in this clinical trial for Short Bowel Syndrome (a condition where a large part of the small intestine is missing or not working properly)

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Rostock University Medical Center Rostock Germany
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
Asklepios Klinik St George Hamburg Germany
Samodzielny Publiczny Szpital Kliniczny Im. Prof. W. Orlowskiego CMKP Warsaw Poland
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Hopital Beaujon Clichy France
Wjpzlqiwiw Svomadsmtneduxq Sdrxbgp Ikn Md Pcfcludd W Ljcwy Lodz Poland
Siofuip Sndmjve Sst z osbo Skawina Poland
Glphzk Ucjmnjprfw Fcyljital Frankfurt Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
28.12.2025
France France
Not recruiting
28.12.2025
Germany Germany
Not recruiting
28.12.2025
Poland Poland
Not recruiting
28.12.2025

Trial locations

Investigated drugs:

Glepaglutide is an investigational medication being studied for the treatment of short bowel syndrome in adults. Short bowel syndrome is a condition where the intestines cannot properly absorb enough nutrients and fluids because part of the small intestine is missing or not working correctly. This medication is designed to help improve how the remaining intestine functions, potentially reducing the need for intravenous nutrition or fluids that patients with this condition often require.

Short Bowel Syndrome – Short Bowel Syndrome is a condition that occurs when a significant portion of the small intestine is missing or has been surgically removed. The small intestine is responsible for absorbing nutrients and fluids from food, and when a large section is absent, the body cannot properly absorb what it needs. People with this condition often experience diarrhea, dehydration, and malnutrition because their remaining intestine cannot adequately process food and liquids. The severity depends on how much of the small intestine remains and which specific sections are affected. Over time, the remaining intestine may adapt somewhat to improve absorption, but many patients continue to require nutritional support. This is considered a rare disease that significantly impacts daily life and nutritional status.

Trial ID:
2025-520775-81-00
Protocol code:
ZP1848-25009
Trial Phase:
Therapeutic confirmatory (Phase III)

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