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

Phase 4

Completed

Brief 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.

Detailed Description: The specific aims of this study are to:

* To evaluate the effects of liraglutide on body weight loss in patients who are experiencing weight regain following RYGB.

* To evaluate the effects of liraglutide on cardiometabolic risk and quality of life in patients who are experiencing weight regain following RYGB.

* To evaluate the safety of liraglutide in post-RYGB subjects.

* To evaluate the changes in obesity-related comorbid conditions in patients who are experiencing weight regain following RYGB.

Recruitment & Eligibility

Inclusion Criteria

≥18 months status-post RYGB
BMI 27 kg/m2 or greater in the presence of at least one weight-related comorbid condition
BMI 30 kg/m2 or greater
Regain of ≥10% of maximum TBWL post-RYGB
Ability to provide informed consent before any trial-related activities
Express willingness to follow protocol requirements

Exclusion Criteria

Pregnancy at time of enrollment
Intention of becoming pregnant or breast feeding in the next 12 months
Females of childbearing potential who are not using adequate contraceptive methods
Presence of acute psychiatric problems or immaturity which would compromise cooperation with the study protocol
Presence of biliary disease
Known or suspected allergy to liraglutide or any product components
Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
History of pancreatitis
History of alcoholism
History of Type 1 DM (Diabetes Mellitus)
History of previous bariatric surgery other than RYGB except h/o LAGB and band removal.
>10 years status-post RYGB
< 25% TBWL at post-RYGB weight nadir
>50% post-operative TBWL at time of screening
Simultaneous use of any weight loss medications
Use of insulin at the time of enrollment
Current use of any GLP-1 agonist medication
History of taking any GLP-1 agonist medication
Participation in another ongoing clinical study
Conditions that, in the opinion of the principal investigator, may jeopardize the patient's well-being and/or the soundness of this clinical study

Arm && Interventions

Group	Intervention	Description
Saxenda	Saxenda	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	Placebo	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

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Losing at Least 5% Enrollment Body Weight Measured Using Cochran-Mantel-Haenszel (CMH) Test	12 Months	CMH is a test used in the analysis of stratified or matched categorical data. It allows testing of the association between a binary predictor or treatment and a binary outcome such as case or control status while taking into account the stratification

Secondary Outcome Measures