Efficacy of Liraglutide Therapy in Patients With an Ileal -Pouch Anal Anastomosis (IPAA) and Chronic High Bowel Frequency

20-3016

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.

2022-03-22

2023-10-16

2023-10-16

Completed

Early phase I

8

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomized, double-blind, 2-period, placebo-controlled, crossover proof of concept study.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 8, 'type': 'ACTUAL'}}

2023-10-17