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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

Timeline

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

Select...

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 4, week 10

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Liraglutide Pen Injector

2021

Completed Phase 2

~40

Placebo Pen Injector

2022

Completed Phase 2

~10

0 / 1Eligibility criteria met

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

Recent research and studies

clinicaltrials.govStudy

Efficacy of Liraglutide Therapy in Patients With IPAA

2022. "Efficacy of Liraglutide Therapy in Patients With IPAA". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04763564.