NCT07859150Not yet recruitingPhase 4
Semaglutide 2.4 mg Once Weekly for Recurrent Weight Gain After Metabolic and Bariatric Surgery (RESURGE)
Semaglutide 2.4 mg Once Weekly for Recurrent Weight Gain After Metabolic and Bariatric Surgery (RESURGE): a Randomized, Double-Blind, Placebo-Controlled Trial
Source: ClinicalTrials.gov · Last updated 5 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 104 (estimated)
- First submitted
- 29 Sept 2026
- Start date
- Oct 2026
- Primary completion date
- Apr 2029
- Lead sponsor
- General Committee of Teaching Hospitals and Institutes, Egypt
- Diseases
- Obesity
- NCT number
- NCT07859150
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 104
- From Oct 2026 to the primary completion date, Apr 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Revisional or conversion bariatric surgery of any type, or revisional surgery planned during the trial period.
- 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.
- 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.
- Ongoing treatment with medications with clinically significant effects on body weight (including systemic glucocorticoids for more than 2 weeks).
Other illness
- 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.
- 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.
- 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 hypersensitivity to semaglutide or excipients.
Other
- Known or suspected alcohol or substance misuse.
- Participation in another interventional trial within 3 months.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The surgical department of Medical Research Institute Hospital, Alexandria University Coordinator of this site? Confirm its status | Alexandria | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.