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

NCT07859150 · tracked via the Priya Life Science Egypt tracker

Sponsor

General Committee of Teaching Hospitals and Institutes, Egypt

Phase

Phase 4

Started

2026-10

Last updated

2026-10-05

Condition(s) studied

Morbid Obesity

Investigational drug(s) / intervention(s)

Semaglutide weekly injection →Placabo

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.

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

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

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.

Primary outcome measure(s)

Mean percentage change in body weight from randomization — week 0 to week 68
Measured in Kilograms

Trial sites (1)

Facility	City	Region	Status
The surgical department of Medical Research Institute Hospital, Alexandria University	Alexandria	Egypt

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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07859150 on ClinicalTrials.gov ↗ ← All trials in Egypt