Semaglutide is a medication from the class of drugs called glucagon-like peptide-1 agonists that promote weight loss. There is little clinical data on the best strategy to achieve weight maintenance following weight reduction induced by semaglutide. For people who need to discontinue treatment, it is unknown whether the weight regain, its accompanied health benefits could be ameliorated with a gradual reduction in semaglutide. The investigators will study if a gradual reduction of semaglutide is associated with different heart risk profile and hormones involved in energy regulation as compared to immediate treatment cessation.
Men and women with previously diagnosed BMI ≥ 30 kg/m2 or BMI ≥ 27 kg/m2 and adiposity-related complications (such as osteoarthritis, nonalcoholic liver disease, sleep apnea, and hypertension) without preexisting cardiovascular disease or type 2 diabetes.
Age 18 - 75 years inclusive
Ongoing weight-loss treatment consisting of weekly subcutaneous semaglutide at minimum dose of 1 mg/weekly with documented weight reduction of at least 10% of pre-treatment body weight
Stable weight over past 12 weeks (less than 5% change in body weight) (self-reported)
Previously diagnosed cardiovascular disease defined as previous myocardial infarction, previous stroke, or symptomatic peripheral arterial disease.
Currently pregnant or lactating
Previously diagnosed type 2 diabetes
Use of any other pharmacological treatment for weight-loss
Parallel
Gradual dose reduction of semaglutide
DrugPparticipants will reduce semaglutide dosage by 25% every 4-weeks until complete treatment cessation at week 16
Abrupt cessation of semaglutide
DrugCessation of semaglutide at 16-weeks
Differences in changes in body weight between each study group
Differences in body weight change (%) between baseline visit 1 (semaglutide discontinuation) and 5 (16-weeks after complete semaglutide withdrawal) will be compared between the study groups
Differences in 24-h systolic BP levels between each study group
Systolic BP will be assessed as the difference in 24-h ambulatory systolic BP between the study groups at visit 5 (16-weeks after complete semaglutide withdrawal)
Differences in fasting ghrelin between each study group
Differences in fasting ghrelin between the study groups will be assessed at week 5 (16-weeks after complete semaglutide withdrawal)
Changes in body mass index (BMI)
Changes in BMI \[calculated as weight / height2 (in kg/m2)\] between baseline visit 1 (semaglutide discontinuation) and 5 (16-weeks after complete semaglutide withdrawal) will be compared between the study groups
Changes in waist circumference
Changes in waist circumference between baseline visit 1 (semaglutide discontinuation) and 5 (16-weeks after complete semaglutide withdrawal) will be compared between the study groups
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Mount Sinai Hospital, Canada
Lead sponsor
Heart and Stroke Foundation of Canada
Collaborator
