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Study on ZED1227 for Improving Symptoms in Celiac Disease Patients on a Gluten-Free Diet

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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 Celiac Disease, a condition where the immune system reacts to gluten, a protein found in wheat, barley, and rye, causing damage to the small intestine. The study aims to evaluate the effectiveness and safety of a new treatment called ZED1227, which is taken in the form of a hard capsule. Participants in the trial will either receive the ZED1227 capsules or a placebo, which looks like the medication but does not contain the active ingredient.

The purpose of the study is to see if ZED1227 can help improve symptoms of Celiac Disease in individuals who continue to experience symptoms despite following a gluten-free diet. The trial will involve participants taking the capsules for a period of 15 weeks. During this time, participants will continue their usual gluten-free diet and will be asked to report their symptoms using a diary specifically designed for Celiac Disease symptoms.

Throughout the study, participants will have regular check-ups to monitor their health and any changes in their symptoms. The trial will assess the improvement in symptoms such as diarrhea, abdominal pain, bloating, and nausea, as well as any changes in the condition of the small intestine. The study is designed to provide valuable information on whether ZED1227 can be a beneficial treatment for those with Celiac Disease who are not fully relieved by a gluten-free diet alone.

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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and ensuring adherence to a gluten-free diet for at least 12 months.

    A biopsy is performed to assess the condition of the small intestine, specifically looking at the VH:CrD ratio, which should be 2.5 or less.

  2. Step 2

    Baseline visits

    Two baseline visits are scheduled. During these visits, symptoms are recorded using the Celiac Disease Symptom Diary (CDSD).

    A negative pregnancy test is required for female participants under 60 years of age.

  3. Step 3

    Treatment phase

    Participants are randomly assigned to receive either the study medication, ZED1227, or a placebo. Both are administered in the form of hard capsules taken orally.

    The treatment duration is from week 3 to week 15. The specific dosage and frequency are determined by the study protocol.

  4. Step 4

    Symptom monitoring

    Throughout the trial, symptoms such as diarrhea, abdominal pain, bloating, and nausea are monitored and recorded.

    Changes in these symptoms are assessed from the baseline visit to the end of the treatment phase.

  5. Step 5

    Final assessment

    At the end of the treatment phase, a final assessment is conducted. This includes another biopsy to evaluate changes in the small intestine.

    The density of CD3-positive intraepithelial lymphocytes is measured to assess inflammation.

Who can join the trial?

13 criteria

  • Must have signed an informed consent form, which means you agree to participate after understanding the study details.
  • Must be willing to continue your usual eating habits, including dining out and eating at other people's homes during the study.
  • Must be willing to keep following a gluten-free diet (GFD) throughout the study.
  • If you are a woman under 60, you need to have a negative pregnancy test at the start of the study.
  • If you are a woman who can have children, you should use a very effective birth control method, like implants, injections, or birth control pills, to prevent pregnancy during the study.
  • Must be between 18 and 80 years old.
  • Must have a confirmed diagnosis of celiac disease from a biopsy or a specific blood test result from at least 12 months ago.
  • Must have been following a gluten-free diet for at least 12 months before the study starts.
  • Must have a specific genetic marker called **HLA-DQ** that is linked to celiac disease.
  • Must have experienced at least one moderate or severe stomach-related symptom, like diarrhea, stomach pain, bloating, or nausea, in the weeks before the study starts.
  • Must have a biopsy result showing a specific measurement called **VH:CrD ratio** of 2.5 or less from a part of the small intestine.
  • Must not have a current infection with a bacteria called **Helicobacter pylori** and no recent treatment for it in the last two months before the biopsy.
  • Must have a **BMI** (Body Mass Index) between 17.0 and 35 kg/m².

Who cannot join the trial?

20 criteria

  • Having any other serious health condition that might interfere with the study.
  • Being pregnant or breastfeeding.
  • Having a history of severe allergic reactions to any of the study medications.
  • Using certain medications that might interfere with the study results.
  • Having participated in another clinical trial recently.
  • Having a history of drug or alcohol abuse.
  • Being unable to follow the study procedures or instructions.
  • Having a condition that affects the immune system, which is the body's defense against infections.
  • Having a history of cancer, except for some types of skin cancer.
  • Having a history of certain heart problems.
  • Having uncontrolled high blood pressure.
  • Having a history of certain liver or kidney problems.
  • Having a history of certain blood disorders.
  • Having a history of certain lung problems.
  • Having a history of certain stomach or intestinal problems.
  • Having a history of certain neurological or mental health problems.
  • Having a history of certain infections.
  • Having a history of certain autoimmune diseases, which are conditions where the immune system attacks the body.
  • Having a history of certain metabolic disorders, which are conditions that affect how the body uses food and energy.
  • Having a history of certain genetic disorders, which are conditions passed down from parents to children.
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Investigated drugs

ZED1227 is a medication being studied for its potential to help people with celiac disease who continue to have symptoms even though they are on a gluten-free diet. The trial aims to see if this medication can improve symptoms and help heal the damage in the intestines caused by gluten.

What is already known about the treatment

ZED1227 – ZED1227 is administered in capsule form and is taken orally. It is currently being studied in clinical trials for its potential use in treating celiac disease, particularly in patients who continue to experience symptoms despite adhering to a gluten-free diet. The main therapeutic indication for ZED1227 is to alleviate symptoms and improve mucosal health in individuals with celiac disease. At the molecular level, ZED1227 works by inhibiting the enzyme transglutaminase 2, which plays a role in the inflammatory response triggered by gluten in celiac disease. It is classified pharmacologically as an enzyme inhibitor.

Investigated diseases

Celiac Disease – Celiac disease is an autoimmune disorder where the ingestion of gluten leads to damage in the small intestine. When people with celiac disease eat gluten, their immune system responds by attacking the small intestine, specifically the villi, which are small fingerlike projections that line the intestine and promote nutrient absorption. Over time, this damage can lead to symptoms such as diarrhea, abdominal pain, bloating, and nausea. The disease can progress with continued gluten exposure, leading to further intestinal damage and nutrient malabsorption. It is important for individuals with celiac disease to adhere to a strict gluten-free diet to prevent these symptoms and intestinal damage.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-506150-21-00Protocol codeCEC-013/CELEstimated enrolment714 patientsSponsorDr. Falk Pharma GmbH

sourced from the EU Clinical Trials Register and site verification

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