Efficacy of Liraglutide Therapy in Patients With IPAA

Phase 2 Terminated 8 enrolled University of North Carolina, Chapel Hill Novo Nordisk A/S · collab

RandomizedCrossoverQuadruple-blindTreatment

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.

Timeline

Start: 2022-03-22
Primary completion: 2023-10-16
Completion: 2023-10-16

Outcome

Met primary endpoint

Stopped: “Due to an interruption in drug supply, the study was terminated”

registry analysis (superiority test); Liraglutide vs Placebo; p <0.03; Mixed Models Analysis NCT04763564 ↗

paper RESULTS: Liraglutide, but not placebo, reduced daily BF by more than 35% ( P < 0.03). PMID 38668926 ↗

Publications

Results Herfarth H, Long MD, Hansen JJ, Anderson C, English E, Buse JB, Barnes EL. Efficacy and Safety of Liraglutide in Patients With an Ileal Pouch-Anal Anastomosis and Chronic High Bowel Frequency: A Placebo-Controlled, Crossover, Proof-of-Concept Study. Am J Gastroenterol. 2024 Sep 1;119(9):1935-1938. doi: 10.14309/ajg.0000000000002801. Epub 2024 Apr 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Liraglutide	Peptide	1.8 mg	—