Metabolic and bariatric surgery (MBS) is the most effective durable treatment for severe obesity, yet a clinically meaningful proportion of patients experience recurrent weight gain after an initially successful operation. Until recently, research and care in this area were limited by the absence of standardized definitions: reported prevalence of weight recurrence ranged from under 10% to over 90% depending on the metric and threshold applied, and treatment decisions varied by provider.
In 2026, an international two-round modified Delphi study of 66 experts across surgery, obesity medicine, gastroenterology, endocrinology, dietetics, and psychology (Wills et al.) established consensus definitions. The consensus specifies: (i) percentage total weight loss (%TWL) as the preferred measurement approach (94.6% agreement); (ii) surgical non-response as \<10% TWL at 12 months (73.0%); (iii) recurrent weight gain as regain of more than 25% of lost weight from nadir (70.3%); and (iv) a change of up to 10% in percentage excess weight loss from nadir as a normal physiologic fluctuation not requiring intervention (83.8%). The consensus also endorsed 'suboptimal' as the preferred terminology for poor surgical response and reached unanimous agreement that anti-obesity medications may appropriately be prescribed by specialists in this population. These definitions supersede the heterogeneous thresholds used previously, including the \>30% regain threshold of the 2024 IFSO Delphi, and are adopted throughout this protocol. Both IFSO and ASMBS now formally support pharmacotherapy as a therapeutic option for weight recurrence after MBS.
The 2024 IFSO international consensus on obesity management medications in the context of MBS reinforces this pathway: at 92% agreement, medications should generally be considered before revisional surgery for recurrent weight gain; at 100%, medication efficacy appears broadly preserved after MBS; and at 97%, no clear increase in adverse effects after MBS has been demonstrated. RESURGE supplies the randomized evidence behind the first of these statements.
Primary laparoscopic sleeve gastrectomy, Roux-en-Y gastric bypass, or one-anastomosis gastric bypass performed at least 18 months before screening.
Documented initial clinical response: nadir weight loss of at least 20% TWL from preoperative weight.
Recurrent weight gain per Section 5.1: regain >25% of maximal weight lost, confirmed on two measurements at least 14 days apart.
Current BMI >=30 kg/m2, or >=27 kg/m2 with at least one obesity-related complication (type 2 diabetes, hypertension, dyslipidemia, obstructive sleep apnea, metabolic dysfunction-associated steatotic liver disease, or symptomatic osteoarthritis).
Revisional or conversion bariatric surgery of any type, or revisional surgery planned during the trial period.
A surgically correctable anatomical cause of regain identified on the pre-enrolment work-up (Section 5.4), including gastro-gastric fistula or symptomatic pouch outlet abnormality, for which the patient elects surgical management.
Use of any GLP-1-based therapy, tirzepatide, or other anti-obesity medication within 6 months of screening.
Type 1 diabetes; type 2 diabetes treated with insulin.
Parallel
Semaglutide weekly injection
DrugSemaglutide is supplied in pre-filled pens and administered subcutaneously once weekly, on the same weekday, at any time of day. Dose escalation: 0.25 mg (weeks 0-3), 0.5 mg (weeks 4-7), 1.0 mg (weeks 8-11), 1.7 mg (weeks 12-15), 2.4 mg from week 16 to week 68. Participants with unacceptable gastrointestinal symptoms may extend an escalation step by 4 weeks or down-titrate one step; the maintenance dose must be at least 1.0 mg for the participant to remain on treatment, mirroring the tolerance management applied in BARI-STEP.
Placabo
DrugPlacebo pens are identical in appearance, volume, and escalation schedule.
Mean percentage change in body weight from randomization
Measured in Kilograms
absolute weight change
Measured in kilograms
BMI change
Equation: BMI = weight (In kilograms) / \[height (In meters)\]\^2
waist circumference change
Waist circumference is a direct measurement of belly fat that helps assess your risk for chronic health issues like heart disease and type 2 diabetes. Health risk increases when waist size goes past certain thresholds: • Men: High risk starts above 102 cm (40 inches) according to standard guidelines, though some organizations flag risks starting at 94 cm (37 inches). • Women: High risk starts above 88 cm (35 inches), with tighter thresholds starting at 80 cm (31.5 inches) in some regional guidelines.
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
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