NCT07294950RecruitingPhase 3
Impact of Semaglutide Withdrawal on Cardiometabolic Profile and Physiology of Energy Balance: Recovery Effects After Semaglutide Termination
Impact of Semaglutide Withdrawal on Cardiometabolic Profile and Physiology of Energy Balance: a Randomized Controlled Trial Comparing Gradual Dose Reduction With Immediate Treatment Cessation.
Source: ClinicalTrials.gov · Last updated 11 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 98 (estimated)
- First submitted
- 17 Nov 2025
- Start date
- 1 Feb 2026
- Primary completion date
- Sept 2028
- Lead sponsor
- Mount Sinai Hospital, Canada
- Diseases
- Obesity
- NCT number
- NCT07294950
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 98
- From 1 Feb 2026 to the primary completion date, Sept 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previously diagnosed cardiovascular disease defined as previous myocardial infarction, previous stroke, or symptomatic peripheral arterial disease.
- Previously diagnosed type 2 diabetes
- Previous surgical treatment for weight loss such as gastric bypass or gastric band
- Malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy within the previous 5 years (with the exception of basal cell skin cancer)
Other illness
- Any history of eating disorder
- New York Heart Association class II-IV heart failure
- Personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2
Lab values
- Renal dysfunction as evidenced by estimated glomerular filtration rate \< 25 ml/min by CKD-EPI Creatinine Equation
- Hepatic disease considered to be clinically significant (includes jaundice, chronic hepatitis, or previous liver transplant) or transaminases \>2.5X the upper limit of normal
Other
- Currently pregnant or lactating
- Use of any other pharmacological treatment for weight-loss
- Any other factor likely to limit adherence to the study, in the opinion of the investigators
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Leadership Sinai Centre for Diabetes Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.