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Trial · Interventional

Not yet recruitingPhase 4Registry data

Semaglutide 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
20262027202820292030
  1. Ph 4

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

    NCT07859150

    est. 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.

  1. Mean percentage change in body weight from randomization

    Time frame · week 0 to week 68

    Registry description

    Measured in Kilograms

Secondary outcomes(9)
  1. absolute weight change

    Time frame · Baseline till week 68

    Registry description

    Measured in kilograms

  2. BMI change

    Time frame · Baseline till week 68

    Registry description

    Equation: BMI = weight (In kilograms) / \[height (In meters)\]\^2

  3. 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.

  4. 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

  5. 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

  6. 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.)

  7. 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.

  8. 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.

  9. 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
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.

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