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Study on the Long-Term Safety and Effectiveness of Glepaglutide for Patients with Short Bowel Syndrome

Fast replyInvestigationalNo 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 long-term safety and effectiveness of a treatment called Glepaglutide for patients with Short Bowel Syndrome (SBS). Short Bowel Syndrome is a condition where the body cannot absorb enough nutrients and fluids because a significant portion of the small intestine is missing or not functioning properly. The treatment being tested, Glepaglutide, is a solution for injection that is designed to help improve nutrient absorption in these patients.

The purpose of this study is to evaluate how safe Glepaglutide is for long-term use in people with Short Bowel Syndrome. Participants in the study will receive either Glepaglutide or a placebo, which is a substance with no active medication. The study will monitor participants over a period to observe any changes in their condition and to ensure the treatment is safe. The study will also look at how well the treatment works in reducing the need for parenteral support, which is a method of feeding that bypasses the usual process of eating and digestion.

Throughout the study, participants will receive regular check-ups to monitor their health, including assessments of vital signs, heart function through an electrocardiogram (ECG), and various blood and urine tests. The study aims to see if Glepaglutide can help reduce the volume of parenteral support needed and improve the overall quality of life for those with Short Bowel Syndrome. The trial is expected to continue until 2026, providing valuable information on the long-term use of Glepaglutide in managing this condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, the patient must have completed the full treatment phase of the lead-in trial or meet the same criteria as the lead-in trial.

    The patient must provide signed informed consent to participate in this extension trial.

  2. Step 2

    Treatment administration

    The patient will receive glepaglutide, which is a solution for injection.

    The medication is administered through subcutaneous use, which means it is injected under the skin.

    The dosage of glepaglutide is 20.0 mg/mL.

  3. Step 3

    Monitoring and assessments

    Throughout the trial, the patient's safety will be monitored by assessing the incidence and type of adverse events (AEs) and serious adverse events (SAEs).

    Regular checks will be conducted to observe changes from baseline in vital signs, electrocardiogram (ECG), hematology, biochemistry, and urinalysis.

    The trial will also evaluate the immunogenicity, which refers to the immune response to the medication.

  4. Step 4

    Efficacy evaluation

    The trial aims to assess the reduction in weekly parenteral support (PS) volume from baseline.

    A reduction of at least 20% in weekly PS volume from baseline is one of the efficacy endpoints.

    The trial will also evaluate the reduction in the number of days on PS per week and the potential to be weaned off PS completely.

  5. Step 5

    Secondary assessments

    Secondary endpoints include changes in fluid composite effect (FCE) from baseline and reduction in the calculated energy content of parenteral macronutrients.

    The trial will also monitor changes in the patient's weight from baseline.

  6. Step 6

    Trial duration

    The estimated end date for the trial is November 30, 2026.

    The trial began recruiting participants on May 7, 2019.

Who can join the trial?

6 criteria

  • Patients must have a condition called Short Bowel Syndrome, which is a problem where part of the small intestine is missing or not working properly.
  • Patients must have participated in a previous related study, known as the lead-in trial.
  • Patients must have signed a document called an informed consent, which means they agree to participate in the study after understanding what it involves.
  • Patients must have either completed the full treatment phase of the previous study, regardless of how well they followed the treatment plan, or be eligible based on the same rules as the previous study.
  • Both male and female patients can participate in the study.
  • The study is open to patients who are not considered part of a vulnerable population, meaning they are not in a group that needs special protection.

Who cannot join the trial?

3 criteria

  • Patients who are not diagnosed with Short Bowel Syndrome cannot participate. Short Bowel Syndrome is a condition where part of the small intestine is missing or not working properly.
  • Patients who are younger than 1 year old or older than 17 years old cannot participate.
  • Patients who are part of a vulnerable population, such as those who cannot make decisions for themselves, cannot participate.
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Investigated drugs

Glepaglutide is a medication being studied for its long-term safety and effectiveness in patients with short bowel syndrome (SBS). It is designed to help manage symptoms and improve the quality of life for individuals with this condition. The trial aims to assess how well patients tolerate the medication over an extended period and its impact on their health.

What is already known about the treatment

Glepaglutide – Glepaglutide is administered through subcutaneous injection, meaning it is injected under the skin. It is currently being studied in clinical trials, particularly in a Phase 3 extension trial, to assess its long-term safety and effectiveness for patients with Short Bowel Syndrome (SBS). This medication is primarily indicated for the treatment of SBS, a condition where nutrients are not properly absorbed due to a lack of functional 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 – Short Bowel Syndrome is a condition where a significant portion of the small intestine is missing or has been surgically removed. This leads to difficulties in absorbing nutrients, fluids, and electrolytes from food. As a result, individuals may experience symptoms such as diarrhea, malnutrition, and dehydration. Over time, the body may adapt to the reduced intestinal length, but nutritional deficiencies can persist. Patients often require specialized diets and nutritional support to manage the condition. The severity of symptoms can vary depending on the length and function of the remaining intestine.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513374-22-00Protocol codeZP1848-17127Estimated enrolment113 patientsSponsorZealand Pharma A/S

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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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