Name of the study: STRIVE Study (Effectiveness and cost of integrating a protocol with use of Liraglutide 3.0 mg into an obesity service)
Purpose of study:
Adults with obesity are at increased risk of developing associated health complications compared to patients who are of normal weight. Liraglutide 3.0mg (Saxenda) is a drug recently approved for the treatment of obesity, which has demonstrated its safety and effectiveness. In people with obesity, Liraglutide 3.0mg (Saxenda) has been shown to improve blood pressure and diabetes control as well as to prevent diabetes development in those with prediabetes.
The Saxenda pen allows 3mg of Liraglutide to be administered. This is approved by the European Medicines Agency and available within the UK for the treatment of obesity. However, the Saxenda pen is not available in Ireland. Some specialists use the Victoza pen, which contains the same active substance, off license to administer 3mg of Liraglutide for the treatment of obesity. The Victoza pen only allows 1.8mg of Liraglutide to be administered at a time and is usually used to treat Type 2 Diabetes.
Saxenda is not equally effective in all people with obesity and the high cost of the medication makes it less attractive to the health service for use routinely in obesity clinics. Previous studies have shown that patients able to achieve more than 15% weight loss at one year after the treatment (“good” responders) will usually also achieve significant weight loss in the first months of treatment (“early” responders).
The aim of this study is to investigate the effectiveness and cost-effectiveness of Saxenda in the obesity clinic settings with a protocol for targeted use of the medication in patients who are “early” and “good” responders to the treatment. This approach is expected to minimise the side-effects and unnecessary exposure of those who will not achieve significant weight loss with the drug, optimise the costs of the medications and target the patients who will benefit more from its use.
Type of study: Randomized Controlled Trial
Are you recruiting participants for this trail? Yes
Geographical location of study: St Vincent’s Hospital, Dublin
Who can take part:
Men and women who have a BMI more than 35 and a complication of weight. This complication can include: diabetes (Type 2), pre-diabetes, high blood pressure and sleep apnoea
What will participants be asked to do:
If you agree to participate you will be invited to attend a screening visit where any questions you have will be addressed and you will be asked to consent to the study. In addition we will ask you to provide us with a blood sample. This screening visit should take approximately 1 hour.
After your screening visit you will be given an initital appointment with a doctor and a dietitian to begin your weight loss program. You will also see an exercise specialist. You will fill in a number of questionnaires reflecting on your health status and be randomly allocated to receive either the study drug Liraglutide 3.0mg (Saxenda) or standard care as your treatment.
There will be a total of 13 visits (15 visits for patients who will be on Saxenda) in St Vincents over a period of 2 years. At these visits you will see a doctor and dietitian to review your progress. You will also be followed up by an exercise physiologist.
If you have been allocated to the group that will receive Liraglutide 3.0mg (Saxenda), a decision regarding whether you will continue or stop the medication will be made by your doctor at 16 weeks, 32 weeks and 1 year based on the weight loss that you have achieved. If you do not achieve the weight loss targets you will stop Saxenda treatment and continue in the study seeing a doctor, dieititian and exercise physiologist. You will stop the medication because it may indicate that you are not responding to the drug in the most effective way and continued exposure to the drug is unnecessary.
Patients with diabetes will also be provided with training to record finger prick glucose results taken as part of routine self-monitoring in a diary.
Recruitment Start Date: 04/06/2018
Recruitment Finish Date:27/07/2018
Study Duration:2 years
This study is funded by: University of Leicester
Contact Details : Aisling Mangan