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Glucagon-like peptide-1 receptor agonist

Liraglutide Pen Injector for Irritable Bowel Syndrome

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
Patients with IPAA and bowel frequency > 8 bowel movements in 24 hours on at least 4 of 7 days/week and presence of high bowel frequency > 4 weeks despite adequate therapy for acute pouchitis or Crohn's like disease of the pouch
Be older than 18 years old
Must not have
Be younger than 18 years old
Screening 3 weeks
Treatment Varies
Follow Upweek 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
  • Irritable Bowel Syndrome
  • Pouchitis

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
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.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 4, week 10
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 4, week 10 for reporting.

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.
First Studied
Drug Approval Stage
How many patients have taken this drug
Liraglutide Pen Injector
Completed Phase 2
Placebo Pen Injector
Completed Phase 2

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor
1,461 Previous Clinical Trials
4,129,122 Total Patients Enrolled
6 Trials studying Irritable Bowel Syndrome
449 Patients Enrolled for Irritable Bowel Syndrome
Novo Nordisk A/SIndustry Sponsor
1,476 Previous Clinical Trials
2,368,568 Total Patients Enrolled
Hans Herfarth, MD, PhDPrincipal InvestigatorUniversity of North Carolina
3 Previous Clinical Trials
196 Total Patients Enrolled

Media Library

Liraglutide Pen Injector (Glucagon-like peptide-1 receptor agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04763564 — Phase 2
Irritable Bowel Syndrome Research Study Groups: Liraglutide then Placebo, Placebo then Liraglutide
Irritable Bowel Syndrome Clinical Trial 2023: Liraglutide Pen Injector Highlights & Side Effects. Trial Name: NCT04763564 — Phase 2
Liraglutide Pen Injector (Glucagon-like peptide-1 receptor agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04763564 — Phase 2

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
~3 spots leftby Nov 2024