Impact of Semaglutide Withdrawal on Cardiometabolic Profile and Physiology of Energy Balance: a Randomized Controlled Trial Comparing Gradual Dose Reduction With Immediate Treatment Cessation. (REST)

NCT07294950 Phase 3 RECRUITING

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.

Details

Lead sponsor	Mount Sinai Hospital, Canada
Phase	Phase 3
Status	RECRUITING
Enrolment	98
Start date	2026-02-01
Completion	2029-05

Conditions

• Obesity (Disorder)
• Weight Change
• Blood Pressure Monitoring
• Appetite Regulation

Interventions

• Gradual dose reduction of semaglutide
• Abrupt cessation of semaglutide

Primary outcomes

• Differences in changes in body weight between each study group — 32 weeks
  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

Countries

Canada