[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658962":3},{"organization":4,"outcomesModule":7,"designInfo":44,"detailedDescription":54,"studyPopulation":43,"armGroups":55,"interventions":68,"overallOfficials":43,"centralContacts":78,"locations":84,"responsibleParty":100,"collaborators":43,"id":104,"slug":105,"hasResults":106,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":43,"eligibilityCriteria":110,"healthyVolunteers":106,"sex":111,"minAge":112,"maxAge":113,"enrollmentInfo":114,"targetDuration":43,"studyType":117,"phases":118,"briefSummary":120,"conditions":121,"keywords":123,"overallStatus":128,"whyStopped":43,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},{"fullName":5,"class":6},"General Committee of Teaching Hospitals and Institutes, Egypt","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":43},[9],{"measure":10,"description":11,"timeFrame":12},"Mean percentage change in body weight from randomization","Measured in Kilograms","week 0 to week 68",[14,18,21,24,27,30,33,37,40],{"measure":15,"description":16,"timeFrame":17},"absolute weight change","Measured in kilograms","Baseline till week 68",{"measure":19,"description":20,"timeFrame":17},"BMI change","Equation: BMI = weight (In kilograms) \u002F \\[height (In meters)\\]\\^2",{"measure":22,"description":23,"timeFrame":17},"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.",{"measure":25,"description":26,"timeFrame":17},"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.\n\nNormal: Below 5.7% Prediabetes: 5.7% to 6.4% Diabetes: 6.5% or higher",{"measure":28,"description":29,"timeFrame":17},"systolic and diastolic blood pressure","Normal blood pressure is less than 120 mm Hg systolic and less than 80 mm Hg diastolic.\n\nSystolic (Top Number): Measures the pressure in your arteries when your heart beats and contracts.\n\nDiastolic (Bottom Number): Measures the pressure in your arteries when your heart rests between beats.\n\n* Normal: Less than 120 mm Hg systolic and less than 80 mm Hg diastolic.\n* Elevated: 120-129 mm Hg systolic and less than 80 mm Hg diastolic.\n* Stage 1 Hypertension (High Blood Pressure): 130-139 mm Hg systolic or 80-89 mm Hg diastolic.\n* Stage 2 Hypertension: 140 mm Hg or higher systolic, or 90 mm Hg or higher diastolic.\n* Hypertensive Crisis: Higher than 180 mm Hg systolic and\u002For higher than 120 mm Hg diastolic. This requires immediate emergency medical care",{"measure":31,"description":32,"timeFrame":17},"total cholesterol, LDL, HDL, and triglycerides","Normal adult values for a lipid panel are measured in milligrams per deciliter (mg\u002FdL):\n\n* Total Cholesterol: Below 200 mg\u002FdL is desirable. (Borderline high is 200-239 mg\u002FdL, and high is 240 mg\u002FdL and above.)\n* LDL (\"Bad\") Cholesterol: Below 100 mg\u002FdL is optimal. (130-159 mg\u002FdL is borderline high, and 160-189 mg\u002FdL or higher is high.)\n* HDL (\"Good\") Cholesterol: 60 mg\u002FdL and higher is protective. Levels below 40 mg\u002FdL for men or below 50 mg\u002FdL for women are considered low.\n* Triglycerides: Below 150 mg\u002FdL is normal. (Borderline high is 150-199 mg\u002FdL, and high is 200-499 mg\u002FdL.)",{"measure":34,"description":35,"timeFrame":36},"change in fat mass and lean soft tissue mass","(bioelectrical impedance analysis, standardized hydration instructions), with fat-free mass loss reported as a proportion of total weight change and hand-grip strength measured at weeks 0, 32, and 68, so that mass is interpreted together with function per the ESPEN\u002FEASO sarcopenic-obesity framework and current meta-analytic evidence.","weeks 0, 32, and 68",{"measure":38,"description":39,"timeFrame":17},"change in IWQOL-Lite-CT total and domain scores","The IWQOL-Lite-CT (Impact of Weight on Quality of Life-Lite Clinical Trials Version) score ranges from 0 to 100, where 100 represents the best possible quality of life and functioning (meaning zero weight-related impairment).\n\n* Total Score Range: 0-100 (higher = better quality of life)\n* Domain\u002FComposite Scores: 0-100\n* Raw scores are converted or transformed to a 0-100 scale for standard reporting.",{"measure":41,"description":42,"timeFrame":17},"change in GerdQ score","A change in the GerdQ score reflects how gastroesophageal reflux disease (GERD) symptoms and their daily impact respond to treatment or evolve over time.\n\n* Range: The total score spans from 0 to 18.\n* Diagnosis Threshold: A score of 8 or higher indicates a high likelihood of GERD.\n* Components: It evaluates four positive predictors (heartburn, regurgitation, sleep disturbance, and over-the-counter medication use) and two negative predictors (epigastric pain and nausea) over the past 7 days.\n\nDecrease in Score: A lowering score (especially moving from ≥ 8 to \\\u003C 8) typically indicates successful treatment response, reduced symptom frequency, and lower disease impact.\n\n• Increase or No Change: A rising score or a score that remains persistently above 8 suggests ongoing treatment failure, unmanaged symptom triggers, or disease progression.",null,{"allocation":45,"interventionModel":46,"interventionModelDescription":43,"primaryPurpose":47,"observationalModel":43,"timePerspective":43,"maskingInfo":48},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":49,"maskingDescription":43,"whoMasked":50},"TRIPLE",[51,52,53],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR","Randomized evidence for GLP-1 receptor agonism after MBS has accumulated rapidly but in populations that do not correspond to the new consensus definition of recurrent weight gain. GRAVITAS demonstrated that liraglutide 1.8 mg improved glycemia in patients with persistent or recurrent type 2 diabetes after MBS. BARI-OPTIMISE randomized patients with suboptimal weight loss after RYGB or SG to liraglutide 3.0 mg versus placebo and reported 9.4% versus 1.1% weight loss at 24 weeks (treatment effect -8.8%; 95% CI -11.9 to -5.7). A randomized trial of liraglutide 3.0 mg specifically for weight recurrence after RYGB confirmed efficacy in that single-procedure setting. Most recently, the BARI-STEP trial randomized 70 adults at least 1 year after gastric bypass or SG with a suboptimal clinical response, defined as \\\u003C20% weight loss from the date of surgery, to semaglutide 2.4 mg weekly versus placebo for 68 weeks: mean weight change was -18.0% (SD 9.2) with semaglutide versus +0.4% (SD 7.0) with placebo, an adjusted treatment difference of -19.1% (95% CI -23.4 to -14.8), with a safety profile consistent with the known gastrointestinal tolerability of semaglutide and no new safety signals in the post-bariatric population. Meta-analyses support GLP-1 receptor agonists as effective adjuncts after MBS, and semaglutide 2.4 mg is superior to liraglutide 3.0 mg for weight reduction in head-to-head comparison.\n\nNo randomized trial has enrolled patients selected by the consensus definition of recurrent weight gain. BARI-STEP required \\\u003C20% TWL from surgery: 55.7% of its participants were regainers, but only regainers whose loss had already fallen back below 20% TWL. By construction it excludes the patient who achieved an excellent initial response (for example 30% TWL) and has since regained more than 25% of the weight lost while remaining above 20% TWL from surgery, and its own exploratory comparison of the two presentations was underpowered, with the investigators noting that their pathophysiology differs and calling for dedicated studies \\[8\\]. Its participants were also a mean of 83.9 months, seven years, past surgery, long after recurrence had hardened. In addition, one-anastomosis gastric bypass has appeared in a post-MBS randomized trial only as an unspecified fraction of BARI-STEP's 15-patient gastric-bypass subgroup; no trial has enrolled OAGB as a prespecified procedure stratum, and none has been conducted in a Middle East and North Africa population. RESURGE is designed to close these gaps: a randomized, double-blind, placebo-controlled trial of semaglutide 2.4 mg in patients who achieved an initial clinical response (nadir \\>=20% TWL) after primary SG, RYGB, or OAGB, stratified by procedure, who now meet the consensus recurrent weight gain definition, enrolled at the point of diagnosis rather than years later, with prespecified, rigorous measurement of treatment adherence and adverse effects.\n\nSemaglutide 2.4 mg was selected over liraglutide on the basis of superior efficacy. demonstrated safety at 68 weeks in a post-bariatric randomized population, cardiovascular outcome benefit in adults with obesity, and once-weekly administration favoring adherence. A placebo-controlled, double-blind design with an identical lifestyle co-intervention in both arms is retained because lifestyle intensification alone can attenuate regain and because expectation effects on weight-related behavior are non-trivial; blinding is feasible using manufacturer-matched placebo pens through an investigator-initiated study scheme, the supply model used by BARI-STEP. The 68-week treatment duration (16-week escalation plus maintenance) matches the STEP program and BARI-STEP, permitting direct comparability of effect sizes.\n\nThe 2026 ADA and Obesity Association Standards strongly recommend continuing obesity pharmacotherapy through the maintenance phase. The week 68 to 80 off-treatment observation period therefore measures exactly the regain those Standards warn about, in a setting where continuation is often unaffordable, and hands the question of how to stop to the companion TAPER trial (Section 16).",[56,62],{"label":57,"type":58,"description":59,"interventionNames":60},"GLP 1","ACTIVE_COMPARATOR","Once-weekly subcutaneous semaglutide, escalated over 16 weeks (0.25 \u002F 0.5 \u002F 1.0 \u002F 1.7 \u002F 2.4 mg) to 2.4 mg or maximum tolerated dose (minimum 1.0 mg), for 68 weeks, as an adjunct to structured lifestyle intervention (500 kcal\u002Fday deficit, \\>=150 min\u002Fweek moderate activity, protein \\>=60 g\u002Fday)",[61],"Drug: Semaglutide weekly injection",{"label":63,"type":64,"description":65,"interventionNames":66},"Placebo","PLACEBO_COMPARATOR","Matched placebo pen, identical escalation schedule, with the same lifestyle intervention",[67],"Drug: Placabo",[69,74],{"type":70,"name":71,"description":72,"armGroupLabels":73,"otherNames":43},"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.",[57],{"type":70,"name":75,"description":76,"armGroupLabels":77,"otherNames":43},"Placabo","Placebo pens are identical in appearance, volume, and escalation schedule.",[63],[79],{"name":80,"role":81,"phone":82,"phoneExt":43,"email":83},"Mohamed Hany Ashour, Professor, MD","CONTACT","+201002600970","mohamed.ashour@alexu.edu.eg",[85],{"facility":86,"status":43,"city":87,"state":43,"zip":88,"country":89,"countryCode":90,"cosmosGeoPoint":91,"geoPoint":96,"contacts":97},"The surgical department of Medical Research Institute Hospital, Alexandria University","Alexandria","21531","Egypt","EG",{"type":92,"coordinates":93},"Point",[94,95],29.91582,31.20176,{"lat":95,"lon":94},[98,99],{"name":80,"role":81,"phone":82,"phoneExt":43,"email":83},{"name":80,"role":81,"phone":43,"phoneExt":43,"email":83},{"type":101,"investigatorFullName":102,"investigatorTitle":103,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"PRINCIPAL_INVESTIGATOR","Mohamed Hany Ashour","Professor, Surgeon","100658962","phase-4-semaglutide-24-mg-once-weekly-for-recurrent-weight-gain-after-metabolic-and-bariatric-surgery-resurge-100658962",false,"NCT07859150","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","Inclusion Criteria:\n\n* Primary laparoscopic sleeve gastrectomy, Roux-en-Y gastric bypass, or one-anastomosis gastric bypass performed at least 18 months before screening.\n* Documented initial clinical response: nadir weight loss of at least 20% TWL from preoperative weight.\n* Recurrent weight gain per Section 5.1: regain \\>25% of maximal weight lost, confirmed on two measurements at least 14 days apart.\n* Current BMI \\>=30 kg\u002Fm2, or \\>=27 kg\u002Fm2 with at least one obesity-related complication (type 2 diabetes, hypertension, dyslipidemia, obstructive sleep apnea, metabolic dysfunction-associated steatotic liver disease, or symptomatic osteoarthritis).\n* Women of childbearing potential: willing to use highly effective contraception during treatment and for 2 months after the last dose.\n* Able and willing to self-inject weekly, complete the injection diary, attend scheduled visits, and provide written informed consent.\n\nExclusion Criteria:\n\n* Revisional or conversion bariatric surgery of any type, or revisional surgery planned during the trial period.\n* 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.\n* Use of any GLP-1-based therapy, tirzepatide, or other anti-obesity medication within 6 months of screening.\n* Type 1 diabetes; type 2 diabetes treated with insulin.\n* Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2.\n* History of acute or chronic pancreatitis.\n* Symptomatic gallstone disease.\n* Endoscopically active marginal or peptic ulcer, or anastomotic\u002Fsleeve stricture requiring intervention.\n* 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.\n* Estimated glomerular filtration rate \\\u003C30 mL\u002Fmin\u002F1.73 m2; severe hepatic impairment.\n* . Malignancy within the past 5 years (excluding treated non-melanoma skin cancer).\n* Current severe uncontrolled psychiatric illness, active suicidal ideation, suicide attempt within 5 years, or current or past diagnosed eating disorder.\n* Known or suspected alcohol or substance misuse.\n* Ongoing treatment with medications with clinically significant effects on body weight (including systemic glucocorticoids for more than 2 weeks).\n* Known hypersensitivity to semaglutide or excipients.\n* Participation in another interventional trial within 3 months.","ALL","18 Years","65 Years",{"count":115,"type":116},104,"ESTIMATED","INTERVENTIONAL",[119],"PHASE4","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.\n\nIn 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 \\\u003C10% 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.\n\nThe 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.",[122],"Morbid Obesity",[124,125,126,127],"Semaglutide","Recurrent Weight Gain","Metabolic and Bariatric Surgery","RESURGE","NOT_YET_RECRUITING","2026-09-29",{"date":131,"type":132},"2026-10-05","ACTUAL",{"date":134,"type":116},"2026-10",{"date":136,"type":116},"2029-04",{"name":5,"class":6},1]