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Study on the Long-Term Safety of Glepaglutide for Adults with Short Bowel Syndrome

Verified siteInvestigationalNo placebo
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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 focused on studying the condition known as Short Bowel Syndrome (SBS). This is a condition where a significant portion of the small intestine is missing or has been surgically removed, leading to difficulties in absorbing nutrients. The treatment being investigated in this study is a medication called Glepaglutide, which is administered as a solution for injection. Glepaglutide is a synthetic peptide, a type of protein, designed to help improve nutrient absorption in patients with SBS.

The purpose of this study is to evaluate the long-term safety of Glepaglutide treatment in adults who have completed a previous trial. Participants will receive Glepaglutide injections and will be monitored over a period of 104 weeks, which is approximately two years. During this time, researchers will collect information on any side effects or changes in health that occur. The study aims to ensure that Glepaglutide is safe for long-term use and to observe its effects on the participants' health and well-being.

Throughout the study, participants will have regular check-ups to monitor their vital signs, such as heart rate and blood pressure, and to perform tests like blood work and urinalysis. These assessments will help researchers understand how the body responds to Glepaglutide over time. The study will also look at how the medication affects the need for parenteral support, which is a method of feeding that bypasses the usual process of eating and digestion. The goal is to see if Glepaglutide can reduce the amount of parenteral support needed by patients with SBS.

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

    Joining the trial

    Participation begins after signing an informed consent form and completing the full treatment period of the previous trial, EASE SBS 2.

  2. Step 2

    Treatment administration

    The medication used in this trial is glepaglutide, administered as a solution for injection.

    The injection is given subcutaneously, which means it is injected under the skin.

    The dosage is 20.0 mg/mL.

  3. Step 3

    Monitoring and assessments

    Regular monitoring is conducted to evaluate the safety and efficacy of the treatment.

    Primary assessments include tracking any adverse events (AEs) that occur or worsen after the first visit.

    Secondary assessments involve monitoring serious adverse events (SAEs), changes in vital signs, electrocardiogram results, blood tests, and urine tests.

    The presence of antibodies against glepaglutide and related substances is also checked.

  4. Step 4

    Efficacy evaluation

    The trial aims to measure the reduction in the volume of parenteral support (PS) required weekly.

    A significant reduction is defined as a decrease of at least 20% from the baseline or complete weaning off PS.

  5. Step 5

    Trial duration

    The trial is designed to last for 104 weeks.

    The estimated end date for the trial is November 30, 2028.

Who can join the trial?

5 criteria

  • The patient must have a condition called short bowel syndrome, which means they have a shorter than normal small intestine.
  • The patient must have signed an informed consent, which is a document that explains the study and confirms the patient agrees to participate.
  • The patient must have completed the full treatment period of a previous study called the extension trial EASE SBS 2.
  • The study is open to both male and female patients.
  • The study includes patients who are children and adults.

Who cannot join the trial?

9 criteria

  • Patients with a history of severe allergic reactions to the study medication.
  • Individuals who are currently participating in another clinical trial.
  • Patients with certain medical conditions that might interfere with the study, such as severe heart disease.
  • Women who are pregnant or breastfeeding.
  • Individuals with a history of drug or alcohol abuse.
  • Patients who have had a major surgery within the last 3 months.
  • Individuals with uncontrolled high blood pressure.
  • Patients with severe liver or kidney disease.
  • Individuals who are unable to comply with the study procedures.
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Investigated drugs

Glepaglutide is a medication being studied for its safety and effectiveness in treating adults with Short Bowel Syndrome (SBS). This condition occurs when a significant portion of the small intestine is missing or not functioning properly, leading to difficulties in absorbing nutrients. Glepaglutide is designed to help improve nutrient absorption and manage symptoms associated with SBS. The trial aims to assess how safe it is to use glepaglutide over a long period.

What is already known about the treatment

Glepaglutide – Glepaglutide is administered through subcutaneous injection, typically under the skin. It is currently being studied in clinical trials, specifically in a Phase 3 extension trial, to assess its long-term safety and efficacy. The main therapeutic indication for glepaglutide is the treatment of short bowel syndrome, a condition where nutrients are not properly absorbed due to a lack of sufficient small intestine. At the molecular level, glepaglutide works by mimicking the action of a natural hormone that helps to increase the absorption of fluids and nutrients in the intestines. It is classified pharmacologically as a glucagon-like peptide-2 (GLP-2) analog.

Investigated diseases

Short bowel syndrome – This condition occurs when a significant portion of the small intestine is missing or has been surgically removed, leading to difficulties in absorbing nutrients. As a result, individuals may experience malnutrition, diarrhea, and dehydration. The body struggles to absorb enough vitamins, minerals, and fluids, which can lead to various health issues. Over time, the remaining intestine may adapt to improve nutrient absorption, but this process can be slow and incomplete. Patients often need to rely on nutritional support, such as intravenous feeding, to maintain adequate nutrition. The condition can vary in severity depending on the length and function of the remaining intestine.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513373-43-00Protocol codeZP1848-20110Estimated enrolment72 patientsSponsorZealand Pharma A/S

sourced from the EU Clinical Trials Register and site verification

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