drugset / Trial / NCT03048578

Clinical Efficacy and Safety of Using 3.0mg Liraglutide to Treat Weight Regain After Roux-en-Y Gastric Bypass Surgery

NCT03048578

Phase 4 Completed 132 enrolled NYU Langone Health Novo Nordisk A/S · collab
RandomizedParallel-groupDouble-blindTreatment

Summary

This is a randomized, double-blinded, placebo-controlled trial of liraglutide versus placebo over a follow-up period of 12 months in patients at least 18 months following Roux-en-Y gastric bypass (RYGB) who are experiencing weight regain. This study will assess the efficacy of liraglutide in improving cardiometabolic risk profile (as indicated by serum lipids, HbA1c, and waist circumference) and quality of life (as assessed by PHQ-9 (Patient Health Questionnaire), versus placebo in patients at least 18 months following RYGB who are experiencing weight regain as well as the safety of liraglutide in this patient population.

Timeline

Start
2017-05-22
Primary completion
2021-03-02
Completion
2021-03-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Liraglutide Peptide 3 mg

Indications