Actively Recruiting
Impact of Semaglutide Withdrawal on Cardiometabolic Profile and Physiology of Energy Balance: a Randomized Controlled Trial Comparing Gradual Dose Reduction With Immediate Treatment Cessation
Led by Mount Sinai Hospital, Canada · Updated on 2026-02-11
98
Participants Needed
1
Research Sites
34 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
Researchers are studying the effects of gradually reducing semaglutide compared to stopping it all at once in adults living with obesity who have no pre-existing cardiovascular disease or type 2 diabetes. Semaglutide is a medication that helps with weight loss by affecting appetite control, but little is known about the best way to maintain weight after stopping this treatment. This trial aims to understand if tapering off semaglutide affects weight regain, heart risk factors, and hormones that regulate energy differently than stopping immediately. The study involves two groups: one group will reduce their semaglutide dose by 25% every four weeks until stopping completely at week 16, while the other group will stop semaglutide all at once at week 16. This open-label trial will compare changes in body weight, blood pressure, and hormone levels related to appetite and energy balance between these groups over 32 weeks. Participants will have regular visits for monitoring body weight, blood pressure, and blood tests to measure hormones such as ghrelin. Researchers will track changes in these measures to assess the impact of the different withdrawal methods. The total study duration includes 32 weeks of follow-up after treatment cessation to evaluate recovery and cardiometabolic changes following semaglutide withdrawal.
CONDITIONS
Brief 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 30 kg/m2 or higher, or BMI 27 kg/m2 or higher with related health issues like osteoarthritis, liver disease, sleep apnea, or hypertension
- No pre-existing cardiovascular disease or type 2 diabetes
- Age between 18 and 75 years inclusive
- Currently receiving weekly semaglutide injections at a minimum dose of 1 mg with documented weight loss of at least 10% of pre-treatment body weight
- Stable weight for 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 such as heart attack, stroke, or symptomatic peripheral arterial disease
- Currently pregnant or breastfeeding
- Diagnosed type 2 diabetes
- Use of other weight-loss medications
- Previous weight-loss surgery like gastric bypass or band
- History of eating disorder
- Severe kidney dysfunction (eGFR less than 25 ml/min)
- Heart failure classified as New York Heart Association class II-IV
- Significant liver disease or liver enzyme levels more than 2.5 times normal
- Cancer needing chemotherapy, surgery, radiation, or palliative care within last 5 years (except basal cell skin cancer)
- Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2
- Any other factor that may limit study adherence as judged by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 16 weeks
Participants will either gradually reduce their semaglutide dosage by 25% every 4 weeks until complete cessation at week 16, or stop semaglutide treatment abruptly at week 16.
Visits approximately every 4 weeks during dose reduction period
Duration - 16 weeks
Participants are monitored for changes in body weight, blood pressure, and hormone levels after stopping semaglutide treatment.
Visits for assessments up to Week 32
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here