Recovery after stopping semaglutide: effects on weight, heart risk, and appetite

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, parallel-arm randomized trial compares gradual dose reduction of weekly semaglutide to abrupt cessation in adults with obesity who achieved ≥10% weight loss on semaglutide. Participants aged 18–75 with BMI ≥30 kg/m2 (or ≥27 with adiposity-related complications) and without prior cardiovascular disease or type 2 diabetes will be randomized to a tapering protocol or immediate stop. Investigators will measure changes in body weight, blood pressure homeostasis, cardiometabolic markers, and hormones that regulate energy balance over the recovery period. The single-center study is led by Mount Sinai Hospital (Leadership Sinai Centre for Diabetes) in Toronto and requires clinic visits and blood testing to capture physiologic and hormonal responses.

Why it matters

Who can join: the full rules

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 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's running

• Leadership Sinai Centre for Diabetes
  Toronto, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Caroline K Kramer, MD PhD
• Email: caroline.kramer@sinaihealth.ca
• Phone: +1 4165864800 ext 7628

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.