Trial · Interventional
Not yet recruitingPhase 4Registry dataSemaglutide 2.4 mg Once Weekly for Recurrent Weight Gain After Metabolic and Bariatric Surgery (RESURGE)
Overview
- Status
- Not yet recruiting
- Phase
- Phase 4
- Enrollment
- 104 participants (estimated)
- Sponsor
- General Committee of Teaching Hospitals and Institutes, Egypt · Other gov
- Design
- Randomized · Triple masking
- Countries
1 country
Egypt
- Start
- Oct 2026 (estimated)
- Primary completion
- Apr 2029 (estimated)
- Completion
- Apr 2029 (estimated)
- First posted
- 5 Oct 2026
- Last update posted
- 5 Oct 2026
- Conditions
- Morbid Obesity
Timeline
1 trial · 1 not yet recruiting
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 4
Semaglutide 2.4 mg Once Weekly for Recurrent Weight Gain After Metabolic and Bariatric Surgery (RESURGE)
NCT07859150est. Oct 2026 to est. Apr 2029
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- Semaglutide weekly injectionDrug
- PlacaboDrug
Arms2
Active comparator
GLP 1
Once-weekly subcutaneous semaglutide, escalated over 16 weeks (0.25 / 0.5 / 1.0 / 1.7 / 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/day deficit, \>=150 min/week moderate activity, protein \>=60 g/day)
Placebo comparator
Placebo
Matched placebo pen, identical escalation schedule, with the same lifestyle intervention
Primary outcomes1
Outcomes the sponsor listed as primary.
Mean percentage change in body weight from randomization
Time frame · week 0 to week 68
Registry description
Measured in Kilograms
Secondary outcomes(9)
absolute weight change
Time frame · Baseline till week 68
Registry description
Measured in kilograms
BMI change
Time frame · Baseline till week 68
Registry description
Equation: BMI = weight (In kilograms) / \[height (In meters)\]\^2
waist circumference change
Time frame · Baseline till week 68
Registry description
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
Time frame · Baseline till week 68
Registry description
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
systolic and diastolic blood pressure
Time frame · Baseline till week 68
Registry description
Normal blood pressure is less than 120 mm Hg systolic and less than 80 mm Hg diastolic. Systolic (Top Number): Measures the pressure in your arteries when your heart beats and contracts. Diastolic (Bottom Number): Measures the pressure in your arteries when your heart rests between beats. * Normal: Less than 120 mm Hg systolic and less than 80 mm Hg diastolic. * Elevated: 120-129 mm Hg systolic and less than 80 mm Hg diastolic. * Stage 1 Hypertension (High Blood Pressure): 130-139 mm Hg systolic or 80-89 mm Hg diastolic. * Stage 2 Hypertension: 140 mm Hg or higher systolic, or 90 mm Hg or higher diastolic. * Hypertensive Crisis: Higher than 180 mm Hg systolic and/or higher than 120 mm Hg diastolic. This requires immediate emergency medical care
total cholesterol, LDL, HDL, and triglycerides
Time frame · Baseline till week 68
Registry description
Normal adult values for a lipid panel are measured in milligrams per deciliter (mg/dL): * Total Cholesterol: Below 200 mg/dL is desirable. (Borderline high is 200-239 mg/dL, and high is 240 mg/dL and above.) * LDL ("Bad") Cholesterol: Below 100 mg/dL is optimal. (130-159 mg/dL is borderline high, and 160-189 mg/dL or higher is high.) * HDL ("Good") Cholesterol: 60 mg/dL and higher is protective. Levels below 40 mg/dL for men or below 50 mg/dL for women are considered low. * Triglycerides: Below 150 mg/dL is normal. (Borderline high is 150-199 mg/dL, and high is 200-499 mg/dL.)
change in fat mass and lean soft tissue mass
Time frame · weeks 0, 32, and 68
Registry description
(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/EASO sarcopenic-obesity framework and current meta-analytic evidence.
change in IWQOL-Lite-CT total and domain scores
Time frame · Baseline till week 68
Registry description
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). * Total Score Range: 0-100 (higher = better quality of life) * Domain/Composite Scores: 0-100 * Raw scores are converted or transformed to a 0-100 scale for standard reporting.
change in GerdQ score
Time frame · Baseline till week 68
Registry description
A change in the GerdQ score reflects how gastroesophageal reflux disease (GERD) symptoms and their daily impact respond to treatment or evolve over time. * Range: The total score spans from 0 to 18. * Diagnosis Threshold: A score of 8 or higher indicates a high likelihood of GERD. * 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. Decrease in Score: A lowering score (especially moving from ≥ 8 to \< 8) typically indicates successful treatment response, reduced symptom frequency, and lower disease impact. • 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.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 65 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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