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Long-term safety study of apraglutide (weekly injections) in patients with Short Bowel Syndrome

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What is this trial about?

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

This study focuses on patients with Short Bowel Syndrome, a condition where part of the small intestine has been surgically removed, affecting the body's ability to absorb nutrients properly. The study will evaluate a medication called apraglutide, which is a new synthetic peptide that mimics a natural hormone in the body that helps with intestinal function.

The purpose of this research is to assess the long-term safety and how well patients tolerate apraglutide when used over an extended period. The medication will be given as an injection under the skin (subcutaneous injection) using a pre-filled syringe that contains both powder and liquid that need to be mixed before use.

During this long-term study, participants will receive treatment for up to 312 weeks (approximately 6 years). Throughout the study, doctors will monitor various aspects of participants' health, including their need for nutritional support through veins (parenteral support), body weight, sleep quality, and overall quality of life. Regular check-ups will be conducted to ensure participant safety and evaluate how well the treatment is working.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial phase

    You will begin treatment with apraglutide, a medication given as an injection under the skin (subcutaneous use)

    The medication comes as a powder and solvent that needs to be mixed before injection using a pre-filled syringe

    This study is specifically for patients with short bowel syndrome who participated in previous related trials

  2. Step 2

    Regular monitoring visits

    Your health will be monitored through regular check-ups at weeks 52, 104, 152, 216, 264, and 312

    During these visits, medical staff will check:

    - Blood and urine tests

    - Blood pressure and heart rate

    - Heart activity through ECG (electrical recording of heart rhythm)

    - Body weight measurements

    - Changes in your nutrition support needs

  3. Step 3

    Quality of life assessments

    At scheduled visits, you will complete several questionnaires about:

    - Sleep quality

    - Overall health status

    - Treatment satisfaction

    - Daily life impact of nutrition support

    These assessments help track how the treatment affects your daily life

  4. Step 4

    Safety monitoring

    Throughout the study, medical staff will monitor for any side effects, particularly:

    - Reactions at injection sites

    - Digestive system issues

    - Gallbladder and pancreas-related concerns

    - Fluid balance

    - Development of colorectal polyps

    The study continues until January 2030

Who can join the trial?

10 criteria

  • Must be a participant from previous clinical trials (TA799-007 or TA799-013) of apraglutide treatment for short bowel syndrome who:
    • Completed at least 70% of planned doses in the previous trial
    • Completed the last two scheduled visits of the previous trial
    • Did not meet any stopping criteria
    • Must be able to understand and sign an informed consent form
    • For women who can become pregnant:
      • Must use effective birth control during the trial and for 4 weeks after the last treatment
      • Acceptable methods include: birth control pills, vaginal rings, patches, implants, IUD, or having a partner who has had a vasectomy
      • For men with female partners who can become pregnant:
        • Must use effective birth control during the trial and for 2 weeks after the last treatment
        • Must not donate sperm during this period
        • Partners must also use effective birth control during the trial and for 4 weeks after
        • Special exceptions may be made for participants who had to leave previous trials due to circumstances not related to treatment (such as hospitalization from accidents or COVID-19)

Who cannot join the trial?

15 criteria

  • Age below 18 years
  • Pregnancy or breastfeeding women
  • History of intestinal obstruction (blockage in the intestines) in the past 6 months
  • Active inflammatory bowel disease (chronic inflammation of digestive tract)
  • Current cancer or cancer treatment
  • Severe liver disease
  • Severe kidney disease
  • Unstable heart conditions
  • Uncontrolled diabetes (blood sugar levels that are not well managed)
  • Major surgery planned during the study period
  • Participation in another clinical trial within the past 30 days
  • History of drug or alcohol abuse within the past 6 months
  • Any condition that, in the opinion of the study doctor, would make participation unsafe
  • Unable to provide informed consent
  • Known allergies to the study medication or its components
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Investigated drugs

Apraglutide is a medication being studied for patients with Short Bowel Syndrome with Intestinal Failure (SBS-IF). It belongs to a class of drugs called GLP-2 analogues that help improve intestinal absorption. The medication works by helping the intestines better absorb nutrients and fluids from food, which is particularly important for patients who have lost part of their intestines. It is designed to be used as a long-term treatment to help manage the symptoms and complications of Short Bowel Syndrome.

What is already known about the treatment

Apraglutide - A novel peptide medication administered through subcutaneous injection, specifically designed for the treatment of short bowel syndrome with intestinal failure (SBS-IF). This drug belongs to the class of GLP-2 (glucagon-like peptide-2) receptor agonists, which work by promoting intestinal growth and improving nutrient absorption in the remaining bowel tissue. Apraglutide helps enhance intestinal adaptation, reduce dependency on parenteral nutrition, and improve quality of life for patients with short bowel syndrome by stimulating the growth of intestinal epithelial cells and increasing intestinal blood flow, while also reducing intestinal inflammation.

Investigated diseases

Short Bowel Syndrome – A condition that occurs when part of the small intestine is missing or has been surgically removed, resulting in the body's reduced ability to absorb nutrients from food. The condition leads to problems with maintaining proper nutrition and hydration because the remaining intestine cannot absorb enough water, vitamins, and other nutrients from food. People with this condition may experience diarrhea, fatigue, and weight loss. The severity of symptoms depends on which sections and how much of the small intestine are affected. The body may gradually adapt to the shorter bowel over time, though some people may need ongoing nutritional support.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-510389-28-00Protocol codeTA799-012Estimated enrolment152 patientsSponsorVectivBio AG

sourced from the EU Clinical Trials Register and site verification

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