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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 trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

2 criteria

  • 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 trial?

2 criteria

  • 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)
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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.

What is already known about the treatment

Glepaglutide – Glepaglutide is an experimental medication given as an injection under the skin twice weekly at a dose of 10 mg, currently being studied in clinical trials for treating Short Bowel Syndrome in adults. It is designed to help patients whose intestines are too short to absorb enough nutrients and fluids from food, a condition that often requires intravenous nutrition support. The medication works by mimicking a natural hormone called GLP-2, which stimulates the growth and repair of the intestinal lining, helping the remaining bowel absorb more nutrients and reducing the need for artificial feeding support. This drug belongs to a class of medicines called GLP-2 analogs, which are designed to improve intestinal function and adaptation.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-520775-81-00Protocol codeZP1848-25009Estimated enrolment32 patientsSponsorZealand Pharma A/S

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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