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Not Yet Recruiting NCT07859176

Tapered Versus Abrupt Discontinuation of Semaglutide After Treatment of Recurrent Weight Gain or Suboptimal Response Following Metabolic and Bariatric Surgery

Conditions: Morbid Obesity

Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 100
Sponsor: General Committee of Teaching Hospitals and Institutes, Egypt

Location: The surgical department of Medical Research Institute Hospital, Alexandria University Alexandria

Summary

Every course of obesity pharmacotherapy ends. Cost, supply, pregnancy plans, side effects, or the patient's own wish. In Egypt, cost alone makes discontinuation the rule, not the exception. Yet the entire evidence base describes what happens when the drug stops, and none of it tests how to stop. Abrupt withdrawal fails predictably. One year after stopping semaglutide, STEP 1 extension participants had regained two thirds of their lost weight. SURMOUNT-4 showed the same pattern after tirzepatide withdrawal, and meta-analysis confirms it across agents. After MBS specifically, stopping GLP-1 therapy is likewise followed by regain. The guidelines say: do not stop at all. The 2026 ADA and Obesity Association Standards strongly recommend continuing medication through maintenance, and the 2024 IFSO consensus agrees that when medication is needed to hold the benefit after MBS, ongoing treatment is probably necessary, while stating, at 94% agreement, that intermittent therapy and dose-reduction strategies require research. Our patients cannot follow the first recommendation. Cost decides for them. This trial is the research the second sentence asks for: the evidence for the moment when continuing is not an option. Clinicians already taper, on no evidence. A 2025 expert commentary describes 8-to-12-week dose reductions in routine practice and states plainly that the approach is anecdotal and untested (Obesity and Endocrinology 2025). Practice has run ahead of the trial. The general-population trial now exists, and we cite it rather than duplicate it. The REST trial has registered exactly this comparison, gradual 16-week dose reduction versus abrupt cessation, in non-surgical patients with obesity. No such trial exists after MBS.

Eligibility Criteria

Inclusion Criteria: * Previous MBS of any type * On semaglutide 2.4 mg (or maximum tolerated dose of at least 1.7 mg) for at least 6 months * prescribed for recurrent weight gain or suboptimal response * Weight stable within 3% over the last 12 weeks * Patient and physician have decided to discontinue Exclusion Criteria: * Type 2 diabetes requiring continued GLP-1 therapy * Planned revisional surgery within the study period * Pregnancy or conception planned within the study; obesity pharmacotherapy is stopped at least 2 months before any planned conception per current labeling and the 2026 Standards, and such patients follow that pathway, not this protocol * Concurrent use of any other obesity medication

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Source: ClinicalTrials.gov (NCT07859176). StuddyBuddy aggregates publicly available trial information.