CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 132 enrolled
Drug / intervention
Saxenda +1 moredrug
Likely dose
Saxenda 0.6mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03048578
NCT03048578Phase 4Completed
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Clinical Efficacy and Safety of Using 3.0mg Liraglutide to Treat Weight Regain After Roux-en-Y Gastric Bypass Surgery

NYU Langone Health·interventional·Posted Feb 9, 2017·Updated Dec 9, 2022

In Brief

A Phase 4 clinical trial evaluating Saxenda and Placebo for Obesity. Completed, enrolled 132 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity
CountriesUnited States
CollaboratorsNovo Nordisk A/S

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 9, 2017
Enrollment StartMay 22, 2017
Primary CompletionMar 2, 2021
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 9.4 years ago

Interventions

Saxendadrug

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

Placebodrug

Subcutaneous Saline Solution