GLPwatch
Efficacy of Liraglutide Therapy in Patients With IPAA
NCT04763564 · Terminated
Last updated 2026-05-28This clinical trial tests whether the medication liraglutide reduces bowel movements in people with pouchitis or irritable pouch syndrome after 4 weeks of treatment.
What this study is testing ClinicalTrials.gov NCT04763564 ↗
Description as written by the study sponsor.
Patients with an ileal pouch-anal anastomosis(IPAA; pouch) due to refractory inflammatory bowel disease and increased bowel frequency in the absence of significant pouch inflammation will be randomized to liraglutide or placebo in a prospective cross over study.
Treatments tested
- Liraglutide Pen Injector also known as Victoza Drug
Treatment will be initiated at 0.6 mg per day for one week. The patient will be instructed to increase the dose to 1.2/day and 1.8 mg /day in week 2 and in week 3, respectively. From week 3 after the start of the drug until week 6 the patient will apply 1.8 mg/day liraglutide. In case of intolerance (e.g. occurrence of refractory nausea) at a higher dose (e.g. 1.8 mg daily, the highest dose in this trial) liraglutide can be reduced to the previous level.
- Placebo Pen Injector also known as Saline Drug
Matching placebo pens used to administer normal saline in the same fashion as for liraglutide
| Main thing measured | Mean % Reduction of Bowel Frequency in Percent of the Mean 7-day Bowel Frequency After 4 Weeks of Therapy on Liraglutide vs Placebo Compared to Baseline . |
|---|---|
| Sponsor | University of North Carolina, Chapel Hill |
| Conditions studied | Pouchitis, Irritable Pouch Syndrome |
| GLP-1 drugs | liraglutide |
Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT04763564 ↗