Actively Recruiting
Impact of Semaglutide Withdrawal on Cardiometabolic Profile and Physiology of Energy Balance: Recovery Effects After Semaglutide Termination
Led by Mount Sinai Hospital, Canada · Updated on 2026-02-11
98
Participants Needed
1
Research Sites
169 weeks
Total Duration
On this page
Sponsors
M
Mount Sinai Hospital, Canada
Lead Sponsor
H
Heart and Stroke Foundation of Canada
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Impact of Semaglutide Withdrawal on Cardiometabolic Profile and Physiology of Energy Balance: Recovery Effects After Semaglutide Termination
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women with BMI 27 30 kg/m2 or BMI 27 27 kg/m2 with related health issues such as osteoarthritis, nonalcoholic liver disease, sleep apnea, or hypertension without existing cardiovascular disease or type 2 diabetes
- Age between 18 and 75 years inclusive
- Currently receiving weekly subcutaneous semaglutide at a minimum dose of 1 mg with documented weight loss of at least 10% of pre-treatment body weight
- Stable weight over the past 12 weeks with less than 5% change (self-reported)
- Ability to read and understand English
You will not qualify if you...
- History of cardiovascular disease including previous heart attack, stroke, or symptomatic peripheral arterial disease
- Currently pregnant or breastfeeding
- Diagnosed with type 2 diabetes
- Use of other medications for weight loss
- Previous weight loss surgery such as gastric bypass or gastric band
- History of eating disorders
- Renal dysfunction with estimated glomerular filtration rate under 25 ml/min
- New York Heart Association class II-IV heart failure
- Significant liver disease or elevated liver enzymes above 2.5 times normal
- Cancer requiring treatment within the past 5 years except basal cell skin cancer
- Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2
- Any condition that may limit study adherence as judged by investigators
AI-Screening
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Trial Site Locations
Total: 1 location
1
Leadership Sinai Centre for Diabetes
Toronto, Ontario, Canada, M5T 3L9
Actively Recruiting
Research Team
C
Caroline K Kramer, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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