Clinical Efficacy and Safety of Using 3.0mg Liraglutide to Treat Weight Regain After Roux-en-Y Gastric Bypass Surgery
Condition: Obesity
Intervention: Saxenda; Placebo
Intervention description: 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; Subcutaneous Saline Solution
Intervention MeSH terms: Liraglutide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomization will be 2:1 (drug:placebo) with stratification by gender and percent post-operative TBWL (25%, 25 - 49.9%).
Masking: Double (Participant, Care Provider)
Enrollment: 132.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Roux-en-Y gastric bypass (RYGB)

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.
    

Eligibility criteria:

        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