Evaluation of Liraglutide 3.0mg in Patients With Poor Weight-loss and a Suboptimal Glucagon-like Peptide-1 Response
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional
Phase: Phase 4

Summary: 
      A double-blinded, randomised, placebo-controlled trial of liraglutide 3.0 mg in patients with
      poor weight-loss and a suboptimal glucagon-like peptide-1 response following bariatric
      surgery
    

Detailed description: 
      Subjects with poor weight loss response (<20% of their total weight) following 1 year or more
      primary gastric bypass or primary sleeve gastrectomy, will be identified from the trial site
      (University College London Hospital) and participant identification centre (Whittington
      Hospital) and invited to attend a screening visit. The screening assessment will be
      undertaken only upon patients providing informed consent to undergo such procedure.
      Information regarding medical history and concomitant medications will be gathered. In
      addition, full physical examination, blood test and a meal test will be performed. All female
      participants of childbearing potential will be tested for pregnancy. Once all data related to
      the screening visit has been acquired, the investigator will review the participants'
      eligibility for BARI-OPTIMISE trial. Patients with suboptimal GLP-1 response and fulfilling
      the inclusion and exclusion criteria will be invited to take part in the trial and asked to
      sign a second consent form. Assurance of adequate use of contraceptive throughout the trial
      period will be obtained before a written informed consent is sought. Consented participants
      will then be asked to attend a baseline visit.

      During the baseline visit, data such as body weight, body composition, physical function,
      physical activity level and health-related quality of life will be collected. Adverse events
      will be reviewed and a meal test will be repeated. Upon completion of all the baseline
      procedures, participants will be randomised to receive either subcutaneous injection of
      liraglutide 3.0 mg or identical placebo for 24 weeks. Participants will be counselled for a
      calorie-reduced diet and to increase their level of physical activity. Participants will also
      be taught how to self-administer the treatment (by subcutaneous injection). For safety
      purpose, subject visits will be carried out at weeks 2, 4, 8, 17 and 24 of the treatment
      initiation. At all these visits, targeted physical examination will be performed and adverse
      events will be assessed. End-of-study visit will be over the phone 4 weeks after the end of
      treatment (i.e. week 28).
    

Intervention name(s): Liraglutide Pen Injector [Saxenda]; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Daily injection of GLP-1 agonist (liraglutide 3.0 mg) for obese patients presenting poor weight loss (<20%) after bariatric surgery and suboptimal GLP-1 levels.; Daily subcutaneous injection
Other intervention name(s): Saxenda
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study is a double-blind, randomised, placebo-controlled, two-arm, parallel group, single-site trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: obesity; GLP-1; liraglutide; diabetes; bariatric surgery