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Recruiting Phase 3 NCT07294950

NCT07294950 Impact of Semaglutide Withdrawal on Cardiometabolic Profile and Physiology of Energy Balance: Recovery Effects After Semaglutide Termination

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Clinical Trial Summary
NCT ID NCT07294950
Status Recruiting
Phase Phase 3
Sponsor Mount Sinai Hospital, Canada
Condition Obesity (Disorder)
Study Type INTERVENTIONAL
Enrollment 98 participants
Start Date 2026-02-01
Primary Completion 2028-09

Trial Parameters

Condition Obesity (Disorder)
Sponsor Mount Sinai Hospital, Canada
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 98
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2026-02-01
Completion 2028-09
Interventions
Gradual dose reduction of semaglutideAbrupt cessation of semaglutide

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Brief Summary

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

Inclusion Criteria: * 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) * Ability to read and understand English Exclusion Criteria: * 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 * Previous surgical treatment for weight loss such as gastric bypass or

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