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

Recruiting now · Phase 3

Conditions studied: Obesity (Disorder), Weight Change, Blood Pressure Monitoring, Appetite Regulation

In brief

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.

Key facts

Study ID

NCT07294950

Run by

Mount Sinai Hospital, Canada

People needed

98

Starts

2026-02-01

Expected to finish

2029-05-01

Last updated by the study team

2026-02-11

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 gastric band
• Any history of eating disorder
• Renal dysfunction as evidenced by estimated glomerular filtration rate < 25 ml/min by CKD-EPI Creatinine Equation
• New York Heart Association class II-IV heart failure
• Hepatic disease considered to be clinically significant (includes jaundice, chronic hepatitis, or previous liver transplant) or transaminases >2.5X the upper limit of normal
• Malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy within the previous 5 years (with the exception of basal cell skin cancer)
• Personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2
• Any other factor likely to limit adherence to the study, in the opinion of the investigators

Where it is running

• Leadership Sinai Centre for Diabetes — Toronto, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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