Recruiting
Phase 3

Semaglutide

Sponsor:

Mount Sinai Hospital, Canada

Code:

NCT07294950

Conditions

Obesity (Disorder)

Weight Change

Blood Pressure Monitoring

Appetite Regulation

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Gradual dose reduction of semaglutide

Abrupt cessation of semaglutide

Study Details

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.

Conditions

Obesity (Disorder)

Weight Change

Blood Pressure Monitoring

Appetite Regulation

Study ID

NCT07294950

Start date

Feb 1, 2026

Status verified date

Oct, 2025

Completion date

May, 2029

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

98 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Gradual dose reduction of semaglutide

Participants will reduce semaglutide dosage by 25% every 4-weeks until complete treatment cessation at week 16

active comparator: Cessation of semaglutide

Participants will discontinue treatment at once at week 16

Interventions

Gradual dose reduction of semaglutide

Pparticipants will reduce semaglutide dosage by 25% every 4-weeks until complete treatment cessation at week 16

Abrupt cessation of semaglutide

Cessation of semaglutide at 16-weeks

Primary outcome measure

  • Differences in changes in body weight between each study group [ Time Frame: 32 weeks ]

Central Contacts and Locations

Central contacts

Caroline K Kramer, MD PhD

+1 4165864800 ext 7628caroline.kramer@sinaihealth.ca

Locations

Leadership Sinai Centre for Diabetes

Recruiting

Toronto, Ontario, Canada, M5T 3L9

Contacts

Caroline K Kramer, MD PhD

+14165864800 ext 7628caroline.kramer@sinaihealth.ca

More Information

Sponsor

Mount Sinai Hospital, Canada

Last update posted

Feb 11, 2026

Last verified

Oct, 2025

Keywords

  • Randomized controlled trial
  • Interventional

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mount Sinai Hospital, Canada on 2026-02-11.