We are pleased to say that enrollment for the last cohort is now being filled and recruitment for the study has been paused until further notice. Thank you to all who have signed up!
In the event the study requires additional patients to complete enrollment we will reopen the prescreening portal for additional recruitment needs, and we greatly appreciate your patience and interest in participating. Please check back at a later time for updates.
Who can join the LILY study?
You may be eligible to join this study if you meet the following requirements:
You are 18-70 years old
You have celiac disease
You are on a gluten-free diet
You have medical proof of diagnosed celiac disease either by biopsy or blood test
Other requirements will apply.
Fill out the following screening survey to see if you may qualify:
What Can Study Participants Expect?
Depending on whether you join Part A or Part B, your participation in the LILY study will last either 7 or 9 months and will consist of the following parts:
Screening and Randomization (up to 1 month)
To see if you qualify, you will visit the study clinic and receive health assessments, such as a physical exam, blood tests, and cognitive tests.
If you qualify, you will be randomly assigned to receive either the study medication or placebo (no active ingredients). You have a 3 in 4 chance of receiving the study medication.
Part A (up to 6 months)
You will have 1 dose of the study medication and visit the study clinic at least 6 times. On your first visit, you will stay overnight at the study clinic for 3 nights in a row to ensure your safety.
Your total participation in this study will last approximately 25 weeks and up to 13 study visits to the study site.
Part B (up to 8 months)
You will have 7 doses of the study medication and visit the study clinic at least 12 times.
Your total participation in this study will last approximately 35 weeks and up to 21 study visits to the study site. Some follow-up visits may occur remotely. Your study doctor will provide more information if applicable.
Participation in a clinical study is voluntary. You can ask any questions you have and may leave the study at any time, for any reason.
Who can join the LILY study?