Impact of Semaglutide Withdrawal on Cardiometabolic Profile and Physiology of Energy Balance: Recovery Effects After Semaglutide Termination

Sponsor
Mount Sinai Hospital, Canada
Study ID
NCT07294950
Phase
PHASE3
Status
Recruiting
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Conditions

  • Appetite Regulation
  • Blood Pressure Monitoring
  • Obesity (Disorder)
  • Weight Change

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Feb 1, 2026
Status verified
Oct 2025
Primary completion
Sep 30, 2028
Completion
May 31, 2029

Study Design

Enrollment
98 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

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

Central Contacts

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