NCT03341429

Evaluation of Liraglutide 3.0mg in Patients With Poor Weight-loss and a Suboptimal Glucagon-like Peptide-1 Response

BARI-OPTIMISE: 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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: University College, London · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	Liraglutide Pen Injector [Saxenda]	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.
DRUG	Placebo	Daily subcutaneous injection

Timeline

• Start date: 2018-08-22
• Primary completion: 2019-11-28
• Completion: 2020-06-11
• First posted: 2017-11-14
• Last updated: 2020-11-05

Locations

1 site across 1 country: United Kingdom