7 Multi-center, double-blind, randomized, placebo-controlled, event-driven superiority trail 804 participating clinical sites in 41 countries Enrollment Criteria Intervention o 1:1 double-blinded non-stratified randomization to receive either 2.4mg semaglutide SC weekly or placebo o Initial dose of 0.24mg weekly x 4 weeks, uptitrated to 0.5, 1.0, 1.7, and eventually 2.4mg every 4 weeks If significant adverse effects encountered, patients could be placed on slower uptitration, pause treatment, or continue reduced maintenance dose therapy o Placebo/semaglutide discontinued if: Patients became/planned to become pregnant Developed pancreatitis Calcitonin level 100 ng/L Patients were to continue on treatment if diabetes was diagnosed after initiation of treatment/placebo Primary Outcome Composite of death from cardiovascular causes, nonfatal MI, nonfatal stroke, (assessed in time-to-first-event analysis) Secondary Outcome: (all assessed in time-to-first-event analysis) Death from cardiovascular causes Composite heart failure end-point (death from CV causes or hospitalization/urgent medical visit for heart failure) Death from any cause Statistical Analysis o Event-driven trial designed to provide 90% power to detect relative risk reduction of 17% for primary endpoint (HR 0.83) at overall one-sided significance level of 0.025 o Required minimum 1225 primary end-point events accrued o Intention-to-treat analysis performed o Hazard ratios and 95% confidence intervals generated with Cox proportional hazard model Baseline Characteristics 17604 patients randomized between Oct
Geographic Service Availability: According to Direct Meds website information current as of January 2026, the platform provides services to most US states but does not currently serve residents of Mississippi or Louisiana, where telehealth prescription of weight loss medications is restricted by state law
Its typically prescribed to people with a BMI of 30 or higher, or 27+ with a weight-related condition (like high blood pressure or high cholesterol)
Context for other GLP-1 products The generic semaglutide approvals apply only to injectable semaglutide and do not affect tirzepatide products Mounjaro and Zepbound, which remain under patent in Canada
The decision should be made in consultation with your GP or specialist weight management service based on your individual circumstances
Consider limiting or temporarily avoiding: Red meat, particularly beef and lamb Eggs and egg-based products Cruciferous vegetables (broccoli, cauliflower, Brussels sprouts, cabbage) Allium vegetables (onions, garlic, leeks) Dairy products, especially if lactose intolerant Protein supplements, particularly whey-based products Certain preservatives (sulphites) found in dried fruits and wine Eating smaller portions rather than large meals can help reduce the burden on your already-slowed digestive system
