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

NCT03048578 · Completed

Last updated 2026-05-28

This clinical trial is testing whether a 3.0mg dose of liraglutide can help people who have regained weight after Roux-en-Y gastric bypass surgery lose at least 5% of their starting body weight.

Status Completed The study has finished.

Phase Phase 4 Monitors a drug already on the market.

Type Interventional (clinical trial)

Design Randomized, double-blind treatment study

Participants 132 people

Who can join Ages 18+ · all sexes

Timeline Started 2017-05 · est. completion 2021-03

Where 1 site · United States

What this study is testing ClinicalTrials.gov NCT03048578 ↗

Description as written by the study sponsor.

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.

Treatments tested

Saxenda also known as Victoza Drug

Week 1: 0.6mg/day Week 2: 1.2mg/day Week 3: 1.8mg/day Week 4: 2.4mg/day Week 5 and Onward: 3.0mg/day
Placebo Drug

Subcutaneous Saline Solution

Main thing measured	Percentage of Participants Losing at Least 5% Enrollment Body Weight Measured Using Cochran-Mantel-Haenszel (CMH) Test
Sponsor	NYU Langone Health
Conditions studied	Obesity
GLP-1 drugs	liraglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT03048578 ↗