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Semaglutide Given Before and After Conversion of Sleeve Gastrectomy to Roux-en-Y Gastric Bypass for Recurrent Weight Gain
Sponsor: General Committee of Teaching Hospitals and Institutes, Egypt
Summary
Recurrent weight gain affects 15% to 40% of patients after metabolic and bariatric surgery (MBS). SG is the most performed operation worldwide, and long-term regain after SG is well documented. A 2026 international Delphi consensus has now standardized the definition. This trial uses that definition. So does our companion trial, RESURGE. We have two real treatments. Both work. Neither is enough. Conversion of SG to RYGB gives around 20% additional total weight loss at 12 months across all indications, and less when the indication is poor weight response rather than reflux. Drug therapy also works after MBS. Liraglutide beat placebo by about 8 percentage points in the BARI-OPTIMISE randomized trial. Semaglutide gives around 11% total weight loss and tirzepatide around 14% in pooled retrospective data, including specifically after SG. Most patients do not return to their nadir weight with either option alone. The field is already comparing the two strategies, but only retrospectively. Two 2025 multicenter cohorts compared conversion against GLP-1 therapy after SG. These studies cannot control diet, exercise, supplementation, co-medication, or adherence. They cannot settle the question. The societies agree on the pathway but admit the evidence is weak. The 2024 IFSO position statement and the 2026 ASMBS statement say the same thing: work up the anatomy first; operate when there is a structural problem; consider medical therapy when there is not; and consider combining drug therapy with revision. The 2024 IFSO international consensus goes further: with 92% agreement, it states that medications should generally be considered before revisional surgery for recurrent weight gain. Every one of those recommendations rests on consensus and retrospective data. None rests on a randomized trial. This protocol is that trial.
Official title: Semaglutide Given Before and After Conversion of Sleeve Gastrectomy to Roux-en-Y Gastric Bypass for Recurrent Weight Gain: a Randomized, Double-blind, Placebo-controlled Trial
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2026-10
Completion Date
2029-04
Last Updated
2026-10-05
Healthy Volunteers
No
Conditions
Interventions
Semaglutide weekly injection
Weekly subcutaneous injections from identical, pharmacy-labelled pens. The active arm receives semaglutide 2.4 mg. Escalation: 0.25, 0.5, 1.0, 1.7, 2.4 mg at 4-week steps. If 2.4 mg is not tolerated, the patient stays on the highest tolerated dose of at least 1.0 mg. Patients who cannot tolerate 1.0 mg stop injections but stay in the trial and are analyzed in their arm.
Placebo
Weekly subcutaneous injections from identical, pharmacy-labelled pens. The placebo arm receives matched placebo. Escalation: 0.25, 0.5, 1.0, 1.7, 2.4 mg at 4-week steps. If 2.4 mg is not tolerated, the patient stays on the highest tolerated dose of at least 1.0 mg. Patients who cannot tolerate 1.0 mg stop injections but stay in the trial and are analyzed in their arm.
Locations (1)
The surgical department of Medical Research Institute Hospital, Alexandria University
Alexandria, Egypt