NCT07294950 Impact of Semaglutide Withdrawal on Cardiometabolic Profile and Physiology of Energy Balance: Recovery Effects After Semaglutide Termination
| 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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 98 participants in total. It began in 2026-02-01 with a primary completion date of 2028-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07294950 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Obesity (Disorder). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07294950 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 98 participants.
Is NCT07294950 currently recruiting?
Yes, NCT07294950 is actively recruiting participants. Contact the research team at caroline.kramer@sinaihealth.ca for enrollment information.
Where is the NCT07294950 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT07294950 clinical trial?
NCT07294950 is sponsored by Mount Sinai Hospital, Canada. The trial plans to enroll 98 participants.
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