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NOT YET RECRUITING

NCT07859150

PHASE4

Semaglutide 2.4 mg Once Weekly for Recurrent Weight Gain After Metabolic and Bariatric Surgery (RESURGE)

Sponsor: General Committee of Teaching Hospitals and Institutes, Egypt

View on ClinicalTrials.gov

Summary

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.

Official title: Semaglutide 2.4 mg Once Weekly for Recurrent Weight Gain After Metabolic and Bariatric Surgery (RESURGE): a Randomized, Double-Blind, Placebo-Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

104

Start Date

2026-10

Completion Date

2029-04

Last Updated

2026-10-05

Healthy Volunteers

Conditions

Morbid Obesity

Interventions

DRUG

Semaglutide weekly injection

Semaglutide 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.

DRUG

Placabo

Placebo pens are identical in appearance, volume, and escalation schedule.

Inclusion Criteria: * 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). * Women of childbearing potential: willing to use highly effective contraception during treatment and for 2 months after the last dose. * Able and willing to self-inject weekly, complete the injection diary, attend scheduled visits, and provide written informed consent. Exclusion Criteria: * 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. * Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2. * History of acute or chronic pancreatitis. * Symptomatic gallstone disease. * Endoscopically active marginal or peptic ulcer, or anastomotic/sleeve stricture requiring intervention. * Pregnancy, breastfeeding, or intention to conceive during the trial. Obesity pharmacotherapy is stopped at least 2 months before any planned conception, per current semaglutide labeling and the 2026 Standards. * Estimated glomerular filtration rate \<30 mL/min/1.73 m2; severe hepatic impairment. * . Malignancy within the past 5 years (excluding treated non-melanoma skin cancer). * Current severe uncontrolled psychiatric illness, active suicidal ideation, suicide attempt within 5 years, or current or past diagnosed eating disorder. * Known or suspected alcohol or substance misuse. * Ongoing treatment with medications with clinically significant effects on body weight (including systemic glucocorticoids for more than 2 weeks). * Known hypersensitivity to semaglutide or excipients. * Participation in another interventional trial within 3 months.

Locations (1)

The surgical department of Medical Research Institute Hospital, Alexandria University

Alexandria, Egypt