Impact of Semaglutide Withdrawal on Cardiometabolic Profile and Physiology of Energy Balance: Recovery Effects After Semaglutide Termination

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMount Sinai Hospital, Canada

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Gradual dose reduction of semaglutide
  • Abrupt cessation of semaglutide

Treatment groups

98 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Mount Sinai Hospital, Canada

Lead sponsor

Heart and Stroke Foundation of Canada

Collaborator