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.
SG at least 2 years before screening.
Recurrent weight gain meeting the international Delphi consensus definition. Operational entry threshold for this trial: regain of at least 20% of the maximal weight lost, measured from nadir.
BMI of 35 kg/m² or more, or 30 kg/m² or more with at least one obesity-associated disease, and accepted for conversion to RYGB by the multidisciplinary team.
Upper endoscopy and contrast imaging completed.
Anatomy. These patients need surgery regardless of drug response, so randomizing them is not ethical. They are operated outside the trial. This is the operational form of the rule: anatomical cause, direct surgery; no anatomical cause, eligible for the trial.
Staple-line leak or gastric fistula.
Sleeve stenosis or axial twist.
Hiatal hernia larger than 3 cm.
Parallel
Semaglutide weekly injection
DrugWeekly 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
DrugWeekly 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.
Percentage total weight loss
Measured in kilograms at month 18 after randomization. Baseline is the randomization weight.
BMI change
Equation: BMI = weight (In kilograms) / \[height (In meters)\]\^2
change in HbA1c
An HbA1c level reflects your average blood sugar over the past two to three months, and any meaningful change typically takes at least 6 weeks to show because red blood cells live for about 3 months. Normal: Below 5.7% Prediabetes: 5.7% to 6.4% Diabetes: 6.5% or higher
systolic and diastolic blood pressure
Normal blood pressure is less than 120 mm Hg systolic and less than 80 mm Hg diastolic. Systolic (Top Number): Measures the pressure in your arteries when your heart beats and contracts. Diastolic (Bottom Number): Measures the pressure in your arteries when your heart rests between beats. Normal: Less than 120 mm Hg systolic and less than 80 mm Hg diastolic. Elevated: 120-129 mm Hg systolic and less than 80 mm Hg diastolic. Stage 1 Hypertension (High Blood Pressure): 130-139 mm Hg systolic or 80-89 mm Hg diastolic. Stage 2 Hypertension: 140 mm Hg or higher systolic, or 90 mm Hg or higher diastolic. Hypertensive Crisis: Higher than 180 mm Hg systolic and/or higher than 120 mm Hg diastolic. This requires immediate emergency medical care
total cholesterol, LDL, HDL, and triglycerides
Normal adult values for a lipid panel are measured in milligrams per deciliter (mg/dL): Total Cholesterol: Below 200 mg/dL is desirable. (Borderline high is 200-239 mg/dL, and high is 240 mg/dL and above.) LDL ("Bad") Cholesterol: Below 100 mg/dL is optimal. (130-159 mg/dL is borderline high, and 160-189 mg/dL or higher is high.) HDL ("Good") Cholesterol: 60 mg/dL and higher is protective. Levels below 40 mg/dL for men or below 50 mg/dL for women are considered low. Triglycerides: Below 150 mg/dL is normal. (Borderline high is 150-199 mg/dL, and high is 200-499 mg/dL.)
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