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Methyl (E,6S)-7-[[1-[2-(2-Ethylbutylamino)-2-Oxoethyl]-2-Oxopyridin-3-Yl]Amino]-6-[(3-Methylimidazole-4-Carbonyl)Amino]-7-Oxohept-2-Enoate

This article discusses a clinical trial investigating the use of ZED1227, also known as Methyl (E,6S)-7-[[1-[2-(2-Ethylbutylamino)-2-Oxoethyl]-2-Oxopyridin-3-Yl]Amino]-6-[(3-Methylimidazole-4-Carbonyl)Amino]-7-Oxohept-2-Enoate, in patients with celiac disease who continue to experience symptoms despite following a gluten-free diet. The study aims to assess the drug’s effectiveness in improving celiac disease symptoms and its safety profile.

Table of Contents

What is ZED1227?

ZED1227 is a new medication being studied for the treatment of celiac disease. Its scientific name is methyl (E,6S)-7-[[1-[2-(2-ethylbutylamino)-2-oxoethyl]-2-oxopyridin-3-yl]amino]-6-[(3-methylimidazole-4-carbonyl)amino]-7-oxohept-2-enoate. This medication is being developed as a capsule for oral use.[1]

Purpose of the Study

The main goal of this study is to see if ZED1227 can help improve symptoms in people with celiac disease who are still experiencing problems despite following a gluten-free diet. Researchers want to find out if this medication can:[1]

  • Reduce celiac disease symptoms, as measured by a special diary called the Celiac Disease Symptom Diary (CDSD)
  • Improve the health of the small intestine, specifically looking at the finger-like projections called villi
  • Decrease the severity of non-stool related digestive symptoms like abdominal pain, bloating, and nausea

How ZED1227 Works

While the exact mechanism of ZED1227 is not fully explained in the provided information, it’s being studied as a potential treatment for celiac disease. Celiac disease is an autoimmune disorder where the ingestion of gluten leads to damage in the small intestine. ZED1227 may work by helping to protect the intestines from this damage or by reducing the immune system’s response to gluten.[1]

Eligibility Criteria

To participate in this study, patients must meet certain criteria. Some key points include:[1]

  • Be between 18 and 80 years old
  • Have a confirmed diagnosis of celiac disease
  • Have been following a gluten-free diet for at least 12 months
  • Still experience moderate to severe digestive symptoms despite following a gluten-free diet
  • Have evidence of intestinal damage (specifically, a reduced ratio of villous height to crypt depth in the small intestine)

There are also several conditions that would prevent someone from participating in the study, such as certain other digestive disorders, severe complications of celiac disease, or recent use of specific medications.

Study Design

This study is designed as a Phase II, double-blind, randomized, placebo-controlled trial. This means:[1]

  • Phase II: The study is testing the effectiveness and safety of the drug in a larger group of people with celiac disease.
  • Double-blind: Neither the participants nor the researchers know who is receiving the actual medication and who is receiving a placebo (a harmless substance with no active ingredients).
  • Randomized: Participants are randomly assigned to either receive ZED1227 or a placebo.
  • Placebo-controlled: The effects of ZED1227 will be compared to the effects of a placebo to determine if the medication is truly effective.

Potential Benefits

If successful, ZED1227 could potentially help people with celiac disease who continue to have symptoms despite following a gluten-free diet. The study aims to see improvements in:[1]

  • Overall celiac disease symptoms
  • The health of the small intestine lining
  • Specific symptoms like abdominal pain, bloating, and nausea

Important Considerations

It’s important to note that:[1]

  • Participants must continue to follow their gluten-free diet throughout the study.
  • The study involves several medical procedures, including upper gastrointestinal endoscopies with biopsies.
  • As with any clinical trial, there may be potential risks or side effects that are not yet known.
  • This is a research study, and ZED1227 is not yet approved for general use in treating celiac disease.

If you have celiac disease and are interested in this study, it’s important to discuss it with your healthcare provider to determine if it might be appropriate for you.

Aspect Details
Study Type Phase II, Double-Blind, Randomised, Placebo-Controlled Trial
Drug Name ZED1227 (Methyl (E,6S)-7-[[1-[2-(2-Ethylbutylamino)-2-Oxoethyl]-2-Oxopyridin-3-Yl]Amino]-6-[(3-Methylimidazole-4-Carbonyl)Amino]-7-Oxohept-2-Enoate)
Target Population Celiac disease patients with persistent symptoms despite gluten-free diet
Age Range 18-80 years
Primary Endpoint Change in CDSD GI Specific Symptom Score
Secondary Endpoints Changes in VH:CrD ratio, non-stool GI symptoms, and duodenal mucosal inflammation
Treatment Duration 15 weeks
Key Inclusion Criteria Biopsy-proven celiac disease, adherence to GFD for ≥12 months, persistent symptoms
Key Exclusion Criteria Severe complications of celiac disease, other intestinal diseases, recent use of certain medications

FAQ

  • What is the main goal of this clinical trial? The main goal is to evaluate if ZED1227 can improve celiac disease symptoms in patients who still experience symptoms despite following a gluten-free diet. The study will compare different doses of ZED1227 to a placebo.
  • Who can participate in this trial? Participants must be between 18 and 80 years old, have a confirmed celiac disease diagnosis, have been on a gluten-free diet for at least 12 months, and still experience moderate to severe gastrointestinal symptoms. They must also meet other specific criteria related to their health status and medication use.
  • How will the effectiveness of ZED1227 be measured? The main measure of effectiveness will be the change in celiac disease symptoms as assessed by the Celiac Disease Symptom Diary (CDSD). The study will also look at changes in the structure of the small intestine and the severity of specific gastrointestinal symptoms like abdominal pain, bloating, and nausea.
  • What is the duration of the treatment in this trial? The treatment period for this trial is 15 weeks, during which participants will receive either ZED1227 or a placebo.
  • Are there any specific dietary requirements for participants? Participants must be willing to maintain their current gluten-free diet throughout the trial. They will also be required to consume special gluten-containing bars (SIGE bars) as part of the study protocol.

Ongoing Clinical Trials on Methyl (E,6S)-7-[[1-[2-(2-Ethylbutylamino)-2-Oxoethyl]-2-Oxopyridin-3-Yl]Amino]-6-[(3-Methylimidazole-4-Carbonyl)Amino]-7-Oxohept-2-Enoate

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

    Recruiting

    2 1
    Investigated drugs:
    Austria Croatia Finland Germany Norway Poland +3

Glossary

  • Celiac Disease: An autoimmune disorder where the ingestion of gluten leads to damage in the small intestine. It affects people who are genetically predisposed to the condition.
  • Gluten-Free Diet (GFD): A diet that strictly excludes gluten, a protein found in wheat, barley, and rye. It is the primary treatment for celiac disease.
  • ZED1227: The investigational drug being studied in this trial, also known by its chemical name Methyl (E,6S)-7-[[1-[2-(2-Ethylbutylamino)-2-Oxoethyl]-2-Oxopyridin-3-Yl]Amino]-6-[(3-Methylimidazole-4-Carbonyl)Amino]-7-Oxohept-2-Enoate.
  • Celiac Disease Symptom Diary (CDSD): A tool used to assess and record the severity of celiac disease symptoms experienced by patients.
  • Villous Height to Crypt Depth Ratio (VH:CrD): A measure of the structure of the small intestine, used to assess the degree of damage or healing in celiac disease.
  • Intraepithelial Lymphocytes (IELs): Immune cells found in the lining of the small intestine. Their density is often increased in celiac disease and is used as a marker of intestinal inflammation.
  • SIGE Bars: Special gluten-containing bars used in the study to challenge participants' immune systems in a controlled manner.
  • Placebo: A substance with no active therapeutic effect, used as a control in testing new drugs to determine their effectiveness.
  • Double-Blind Study: A type of clinical trial where neither the participants nor the researchers know who is receiving the actual treatment and who is receiving a placebo.
  • Randomised Controlled Trial: A study design where participants are randomly assigned to either the treatment group or the control group to minimize bias and ensure the groups are comparable.

References

  1. http://clinicaltrials.eu/trial/study-on-zed1227-for-improving-symptoms-in-celiac-disease-patients-on-a-gluten-free-diet/