CompletedPhase 4ACTRN12617001613392

Effect of liraglutide on weight loss in patients with inadequate weight loss following bariatric surgery

Effect of liraglutide on weight loss in patients with inadequate weight loss following bariatric surgery: A Randomised Controlled Trial

Sponsor

Monash University

Enrollment

48 participants

Start Date

Jan 18, 2019

Study Type

Interventional

Conditions

Obesity Failure of adequate weight loss following Laparoscopic Adjustable Gastric Band

Summary

This research project is testing whether a medication called Saxenda (also known as Liraglutide) can help you lose more weight. Saxenda is approved for use as a weight loss therapy in Australia because it has been shown in obese people to cause weight loss after one year of between 5% and 10% body weight. We hypothesize pharmacotherapies can be used to improve weight loss following LAGB

Eligibility

Sex: Both males and femalesMin Age: 20 YearssMax Age: 65 Yearss

Inclusion Criteria1

Patients will be considered for inclusion if they are 12-18 months post LAGB, have achieved a stable weight but have not achieved 12% total body weight loss; are 20-65 years of age. A “Stable Weight” is defined as a weight that is consistent within a 4 kg range over a 3 month period.

Exclusion Criteria2

Patients will be excluded from this study if they: have hypersensitivity to liraglutide or any of its excipients; have a past history of GLP-1 analogue associated pancreatitis; will not accept the randomisation process; have a correctable mechanical issue with the LAGB that could explain the lack of weight loss; have a history of previous obesity surgery other than LAGB; have medical issues which contraindicate the application of either arm of the study such as acute myocardial infarction within the past 6 months, dementia, bulimia, active psychosis, concurrent experimental drug use, current pregnancy, lactation, illicit drug use, excessive alcohol intake, use of drugs known to affect body composition, cytotoxic drugs, internal malignancy, or major organ failure; have used a GLP-1 agonist in the previous 12 months; are unable to understand the risks, realistic benefits and compliance requirements of the interventions.
There has been an increase in thyroid cancer reported in rodent models that have utilised liraglutide 3.0 mg and whilst this has not been validated in humans, patients with a personal or family history of medullary thyroid cancer will be excluded. Pancreatitis has been identified as a potential side effect although no studies to date have confirmed this. Because of this concern patient who are at risk of pancreatitis for other reasons (drugs, excessive alcohol intake, known symptomatic gallstones) will be excluded. Nausea is an expected side effect of liraglutide 3.0 mg and it is possible that the gastric band will need to be deflated acutely if the nausea is severe and causes vomiting. Therefore, patients who reside more than one hour from the Clinic will be excluded. Tachycardia is an occasional side effect of liragulatide 3.0 mg with the mechanism currently unknown. Patients with known tachycardia will therefore be excluded. Patients with congestive heart failure NY-HA class III-IV or inflammatory bowel disease will be excluded.

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Interventions

48 Patients will be recruited to a double blinded randomised placebo trial whereby patients who have undergone LAGB and achieved a stable, reasonable weight loss (EWL 25-40%; TBWL 5-12%) at 12-18 months post-operation are randomised to liraglutide 3.0 mg or placebo. Medications will be provided by the manufacturer (Novo Nordisk). In the active treatment arm liraglutide from pre-filled multidose disposable pens (6mg/ml liraglutide, 3ml) will be utilized in the study. Liraglutide and placebo are solutions for injection. The dose of liraglutide utilized in the study will be 3.0mg administered subcutaneously daily from multidose pens. The placebo (control) arm of the study will utilise saline from identical pre-filled multidose disposable pens. Doses of saline will replicate those administered from the active (liraglutide) arm of the study. Each subject will be trained on how to use the multi-dose pen by the trial coordinator and written directions will be provided. The multi-dose pens will not be disposed we will perform drug accountability and pharmacy reconciliation. Only after drug accountability will pens be sent for destruction. The trial co-ordinator will assess the amount of trial product returned compared to what was dispensed at the last dispensing visit. Drug/placebo administration will occur daily for the 12 month trial duration, 365 days.