Efficacy of Liraglutide Therapy in Patients With IPAA

• Status: Not yet recruiting
• Trial end date: 2024-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Collaborator: Novo Nordisk A/S
• Treatments: Liraglutide

Criteria

Inclusion Criteria:

• Informed consent will be obtained before any trial-related procedures

• Age > 18 years

• 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

Exclusion Criteria:

• Significant pouch inflammation defined as an endoscopic pouch disease activity index (PDAI ) ≥ 4

• Known stricture of the ileo-anal anastomosis or afferent limb stricture

• New onset of high bowel frequency in the setting of acute pouchitis

• IPAA since < 6 months

• Known Clostridium difficile pouchitis

• Known clinically significant chronic nausea and/or vomiting in the past

• Known type 1 or type 2 diabetes

• History of or active neoplasia

• Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2

• Renal impairment defined as glomerular filtration rate (glomerular filtration rate < 30)

• Clinically significant decompensated liver disease defined as elevation of aspartate aminotransferase , alanine transaminase or bilirubin > 2-fold the upper limits of normal (Primary Sclerosing Cholangitis with liver function tests (LFT's) <1.5 upper limits of normal can be included)

• New York Heart Association class 3 or greater heart failure or recent (within 6 months) cardiovascular event

• Prior history of pancreatitis

• Prior treatment with a GLP-1receptor agonist

• Known hypersensitivity to liraglutide or any product components

• Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method.

• Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days before screening.

• Any disorder, which in the investigator's opinion might jeopardize patient's safety or compliance with the protocol.