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Glucagon-like peptide-1 receptor agonist
Liraglutide Pen Injector for Pouchitis
Phase 2
Waitlist Available
Led By Hans Herfarth, MD, PhD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 4, week 10
Awards & highlights
Study Summary
This trial is testing if liraglutide, a medication used to treat diabetes, can also help people with an ileal pouch-anal anastomosis who have increased bowel frequency but no significant pouch inflammation.
Eligible Conditions
- Pouchitis
- Irritable Bowel Syndrome
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 4, week 10
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 4, week 10
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Mean 7-Day Bowel Frequency By 30%
Secondary outcome measures
Change in Clinical Modified Pouch Disease Activity Index (mPDAI) Score
Change in the 7 Day Mean Number of Day and Night Bowel Frequency
Discontinuation of Liraglutide Therapy
Trial Design
2Treatment groups
Experimental Treatment
Group I: Placebo then LiraglutideExperimental Treatment2 Interventions
Participants will be randomly assigned to 6-week placebo treatment. Then after a 5-day washout, treatment will continue with 6 weeks of Liraglutide.
Group II: Liraglutide then PlaceboExperimental Treatment2 Interventions
Participants will be randomly assigned to 6-week Liraglutide treatment. Then after a 5-day washout, treatment will continue with 6 weeks of placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo Pen Injector
2022
Completed Phase 2
~10
Liraglutide Pen Injector
2021
Completed Phase 2
~40
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Who is running the clinical trial?
University of North Carolina, Chapel HillLead Sponsor
1,504 Previous Clinical Trials
4,187,654 Total Patients Enrolled
2 Trials studying Pouchitis
14 Patients Enrolled for Pouchitis
Novo Nordisk A/SIndustry Sponsor
1,513 Previous Clinical Trials
2,415,021 Total Patients Enrolled
Hans Herfarth, MD, PhDPrincipal InvestigatorUniversity of North Carolina
3 Previous Clinical Trials
196 Total Patients Enrolled
1 Trials studying Pouchitis
6 Patients Enrolled for Pouchitis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had or currently have cancer.You have a narrowing or blockage in the connection between the small intestine and the anus.You recently started having frequent bowel movements due to acute pouchitis.You have a diagnosed condition called Clostridium difficile pouchitis.You have had pancreatitis before.You have already been treated with a medication called a GLP-1 receptor agonist.You are allergic to liraglutide or any of its ingredients.You have a history of chronic nausea and/or vomiting.You have a surgically created pouch in your intestines (IPAA) and experience more than 8 bowel movements per day for at least 4 out of 7 days each week. This has been going on for more than 4 weeks, even after trying different treatments for pouchitis or Crohn's-like disease.You or someone in your family has had medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2.
Research Study Groups:
This trial has the following groups:- Group 1: Liraglutide then Placebo
- Group 2: Placebo then Liraglutide
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are we enrolling patients at this time for this experiment?
"Yes, the data on clinicaltrials.gov does show that this study is still looking for participants. According to the site, the trial was first posted on 3/22/2022 and was last updated on 3/23/2022. They are hoping to recruit 10 people total from 1 location."
Answered by AI
Does the Liraglutide Pen Injector have any dangerous side effects?
"Liraglutide Pen Injector is a Phase 2 medication, meaning that while there is data supporting its safety, there is none yet affirming its efficacy. Our team scored it a 2."
Answered by AI
What are the benefits of Liraglutide Pen Injector?
"Liraglutide Pen Injector can help patients struggling with exercise, cardiovascular risk reduction, and lack of success from monotherapy."
Answered by AI
How many people are included in the data sample for this research?
"Yes, the trial is recruiting patients according to the information on clinicaltrials.gov. The listing was created on 3/22/2022 and edited on 3/23/2022. They are looking for 10 more participants at 1 medical facility."
Answered by AI
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