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Randomized Controlled Trial
. 2025 Mar;35(3):775-783.
doi: 10.1007/s11695-025-07671-5. Epub 2025 Jan 30.

A Randomized, Double-Blind, Two-Way Cross-over Study to Evaluate the Efficacy of Liraglutide Treatment in Patients Undergoing Transoral Outlet Reduction Endoscopy for Weight Regain Post Roux-en-Y Gastric Bypass

Ali Lahooti  1 , Anna C Hoff  2 , Brian Critelli  1 , Amier Hassan  1 , Donevan Westerveld  1 , Kaveh Hajifathalian  3 , Enad Dawod  1 , Cynthia O Akagbosu  1 , Waleed Aljohani  1 , Kamal Hassan  1 , Gabriel Cairo Nunes  2 , Sergio Barrichello  2 , Manoel Galvao Neto  2 , Jimi Scarparo  2 , Carolyn Newberry  1 , Sonal Kumar  1 , Reem Z Sharaiha  4
Affiliations
Randomized Controlled Trial

A Randomized, Double-Blind, Two-Way Cross-over Study to Evaluate the Efficacy of Liraglutide Treatment in Patients Undergoing Transoral Outlet Reduction Endoscopy for Weight Regain Post Roux-en-Y Gastric Bypass

Ali Lahooti et al. Obes Surg. 2025 Mar.

Abstract

Background: Transoral outlet reduction endoscopy (TORe) and glucagon-like peptide-1 agonist, liraglutide, have individually shown promise in managing weight regain after Roux-en-Y gastric bypass. However, combined effects of adjunctive liraglutide to TORe remain unexplored. A cross-over design was utilized to evaluate the efficacy of liraglutide treatment when initiated immediately post-TORe or 1 year post-TORe.

Methods: Data was analyzed from a double-blinded randomized controlled trial conducted at three outpatient clinics in São Paulo, Brazil, from January 2019 to December 2021. Two cohorts were established: group placebo then liraglutide (group PL) received subcutaneous saline dosed daily for 12 months after TORe then liraglutide for the subsequent 12 months, while group liraglutide then placebo (group LP) started subcutaneous liraglutide followed by subcutaneous saline in a similar fashion. Each participant received placebo and liraglutide for equal duration over the 24-month treatment phase. The primary outcomes were percent total body weight loss (%TBWL) at 12 and 24 months.

Results: The study comprised 58 participants in group PL and 51 participants in group LP, with no significant difference in mean baseline BMI between groups. Group LP showed significantly higher %TBWL than group PL at 6, 9, and 12 months. Surprisingly, at 21 and 24 months, group LP continued to exhibit greater %TBWL than group PL, even after discontinuing liraglutide.

Conclusion: Immediate post-procedure administration of liraglutide appears to be more effective than placebo in reversing weight regain in patients undergoing TORe. Results indicate that the timing of post-TORe liraglutide initiation may enhance the therapeutic benefits of the procedure.

Keywords: Bariatric endoscopy; Glucagon-like peptide-1 agonist; Roux-en-Y gastric bypass; Transoral outlet reduction endoscopy; Weight regain.

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Conflict of interest statement

Declarations. Ethical Approval: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Informed Consent: Informed consent was obtained from all individual participants included in the study. Competing Interests: Anna C. Hoff is a consultant for Boston Scientific and ERBE Manoel Galvao Neto is a consultant for Apollo EndoSurgery, USGI, SAB, GI Dynamics, Keyron, and Nitinotes Carolyn Newberry is a speaking honorarium for Inbody/Baxter international Sonal Kumar is a consultant and speaking for Novo Reem Z. Sharaiha is a consultant for Boston Scientific, Cook Medical, Olympus

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