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Study of glepaglutide compared to placebo for patients with short bowel syndrome with intestinal failure

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 study involves people with Short Bowel Syndrome, which is a condition where a large part of the small intestine is missing or has been removed, making it difficult for the body to absorb enough nutrients and fluids from food. People with this condition often need parenteral support, which means they receive nutrition and fluids directly into their veins through an intravenous line because their remaining intestine cannot absorb what they need from eating and drinking normally. This type of support is also called intestinal failure, meaning the intestine cannot work well enough on its own to maintain proper nutrition and hydration.

The study will test a medication called glepaglutide, which is given as an injection under the skin twice each week. Some participants will receive glepaglutide while others will receive placebo. The purpose of this study is to confirm whether glepaglutide can help reduce the amount of parenteral support that people with short bowel syndrome need each week. The study will look at whether the medication can decrease the volume of nutrition and fluids that must be given through the veins, and possibly help some people reduce the number of days per week they need this support or even stop needing it completely.

The study is divided into two parts. In the first part, which lasts 24 weeks, participants will be randomly assigned to receive either glepaglutide or placebo, and neither the participants nor the doctors will know which treatment is being given. This part will continue for up to 52 weeks for some measurements. After this, there will be a longer period where all participants will receive glepaglutide and everyone will know they are receiving the actual medication. During the study, doctors will measure changes in the weekly volume of parenteral support needed and track how participants feel about their condition overall.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Treatment assignment

    Upon joining the study, you will be randomly assigned to one of two groups. One group will receive glepaglutide 10 mg, and the other group will receive placebo. A placebo is an inactive substance that looks like the real medication but contains no active ingredient.

    This is a double-blind study, which means neither you nor your doctor will know which treatment you are receiving during the initial phase.

  2. Step 2

    Initial treatment phase

    You will receive injections twice weekly for 24 weeks. The medication or placebo will be administered as an injection under the skin (subcutaneous injection).

    If you are in the glepaglutide group, each injection will contain 10 mg of the active substance. The medication comes as a solution with a concentration of 20.0 mg per milliliter.

    During this period, your parenteral support volume will be monitored. Parenteral support refers to the nutrition and fluids you receive through an intravenous line rather than through eating and drinking.

  3. Step 3

    Assessments at week 8

    At week 8, your weekly parenteral support volume will be evaluated to track changes from the beginning of the study.

  4. Step 4

    Assessments at week 12

    At week 12, another evaluation of your weekly parenteral support volume will be conducted.

  5. Step 5

    Assessments at week 20

    At week 20, your parenteral support volume will be measured to determine if there has been a reduction of at least 20% compared to the start of the study.

  6. Step 6

    Primary assessment at week 24

    At week 24, the main evaluation will take place. Your weekly parenteral support volume will be compared to the volume at the beginning of the study to determine the change.

    You will also be asked to rate your overall condition using the Patient Global Impression of Change scale, which assesses whether you feel your condition has improved.

  7. Step 7

    Extended treatment phase until week 52

    After week 24, you will continue receiving injections twice weekly until week 52. This phase is an open-label extension, which means both you and your doctor will know that you are receiving glepaglutide.

    Throughout this period, your parenteral support requirements will continue to be monitored, including the number of days per week you need parenteral support and the total weekly volume.

  8. Step 8

    Final assessment at week 52

    At week 52, a comprehensive evaluation will be performed. This will include measuring changes in your weekly parenteral support volume, the number of days per week you require parenteral support, and whether you have been able to stop parenteral support completely.

    Any adverse events (unwanted or harmful effects that occur during treatment) experienced throughout the entire study period will be reviewed.

Who can join the trial?

6 criteria

  • You must sign a document showing you agree to take part in the study, called informed consent
  • You must be between 18 and 90 years old
  • You must have a condition called Short Bowel Syndrome, which means your small intestine is shorter than normal. Specifically, your small bowel must be less than 200 centimeters (or 79 inches) in length. Your last surgery to remove part of your intestine must have been at least 6 months ago
  • You must need parenteral support (nutrition given through a vein) at least 3 days per week, and this need must be stable
  • You must not be planning to have surgery to restore your intestine during the time you are in the study
  • You must either have a stoma (an opening in your abdomen where waste leaves your body) or have your colon (large intestine) still connected to your small intestine

Who cannot join the trial?

11 criteria

  • The specific exclusion criteria (reasons why you cannot participate) have not been provided in the available study information
  • Generally, clinical trials may exclude patients based on certain health conditions, medications, or other factors that could affect the study results or patient safety
  • If you have active cancer (uncontrolled growth of abnormal cells in the body), you may not be able to participate
  • If you have severe liver disease (problems with the organ that helps clean your blood and digest food), you may be excluded
  • If you have severe kidney disease (problems with the organs that filter waste from your blood), you may be excluded
  • If you are pregnant or breastfeeding (feeding your baby with milk from your breast), you may not be able to join
  • If you have had recent major surgery on your digestive system, you may be excluded
  • If you are allergic to the study medication or similar medications, you cannot participate
  • If you have uncontrolled diabetes (high blood sugar levels), you may be excluded
  • If you have certain heart problems or recent heart attack (blockage of blood flow to the heart muscle), you may not qualify
  • If you are participating in another clinical trial, you may be excluded
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Investigated drugs

  • Glepaglutide

    is an investigational medication being studied for people with short bowel syndrome who have intestinal failure. This means their intestines are too short or don't work well enough to absorb the nutrients and fluids their body needs. Glepaglutide is given as an injection twice a week and works to help improve the intestine's ability to absorb what the body needs, potentially reducing the patient's dependence on intravenous nutrition or fluids.

  • Placebo

    is an inactive treatment that looks like the real medication but contains no active medicine. It is used in this study to compare against glepaglutide to help determine if glepaglutide truly works. Some participants will receive the placebo during the first part of the study.

What is already known about the treatment

Glepaglutide – Glepaglutide is an injectable medication given under the skin twice weekly at a 10 mg dose, currently being studied in Phase 3 clinical trials for the treatment of Short Bowel Syndrome with Intestinal Failure (SBS-IF). This condition occurs when a large portion of the small intestine is missing or not working properly, making it difficult for the body to absorb enough nutrients and fluids from food. Glepaglutide works by mimicking a natural hormone called GLP-2, which helps the remaining intestine grow and improve its ability to absorb nutrients and water, potentially reducing the need for intravenous nutrition support. It belongs to a class of medications called GLP-2 receptor agonists, which specifically target and activate receptors in the intestinal lining to promote tissue growth and enhance absorption function.

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. This results in the remaining intestine being unable to absorb enough nutrients and fluids from food to maintain proper health. People with this condition often experience severe diarrhea, dehydration, and weight loss because their shortened digestive system cannot process food normally. The syndrome typically develops after extensive bowel surgery, which may be necessary due to various intestinal diseases or injuries. Patients frequently require nutritional support through intravenous feeding, known as parenteral support, to receive adequate nutrition. The severity of the condition depends on how much of the small intestine remains and how well it functions.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512486-14-00Protocol codeZP1848-23029Estimated enrolment99 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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