Trial · Interventional
Not yet recruitingPhase 4Registry dataSemaglutide Given Before and After Conversion of Sleeve Gastrectomy to Roux-en-Y Gastric Bypass for Recurrent Weight Gain
Overview
- Status
- Not yet recruiting
- Phase
- Phase 4
- Enrollment
- 100 participants (estimated)
- Sponsor
- General Committee of Teaching Hospitals and Institutes, Egypt · Other gov
- Design
- Randomized · Quadruple 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 Given Before and After Conversion of Sleeve Gastrectomy to Roux-en-Y Gastric Bypass for Recurrent Weight Gain
NCT07859163est. Oct 2026 to est. Apr 2029
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
Recurrent weight gain affects 15% to 40% of patients after metabolic and bariatric surgery (MBS). SG is the most performed operation worldwide, and long-term regain after SG is well documented. A 2026 international Delphi consensus has now standardized the definition. This trial uses that definition. So does our companion trial, RESURGE. We have two real treatments. Both work. Neither is enough. Conversion of SG to RYGB gives around 20% additional total weight loss at 12 months across all indications, and less when the indication is poor weight response rather than reflux. Drug therapy also works after MBS. Liraglutide beat placebo by about 8 percentage points in the BARI-OPTIMISE randomized trial. Semaglutide gives around 11% total weight loss and tirzepatide around 14% in pooled retrospective data, including specifically after SG. Most patients do not return to their nadir weight with either option alone. The field is already comparing the two strategies, but only retrospectively. Two 2025 multicenter cohorts compared conversion against GLP-1 therapy after SG. These studies cannot control diet, exercise, supplementation, co-medication, or adherence. They cannot settle the question. The societies agree on the pathway but admit the evidence is weak. The 2024 IFSO position statement and the 2026 ASMBS statement say the same thing: work up the anatomy first; operate when there is a structural problem; consider medical therapy when there is not; and consider combining drug therapy with revision. The 2024 IFSO international consensus goes further: with 92% agreement, it states that medications should generally be considered before revisional surgery for recurrent weight gain. Every one of those recommendations rests on consensus and retrospective data. None rests on a randomized trial. This protocol is that trial.
Interventions
- Semaglutide weekly injectionDrug
- PlaceboDrug
Arms2
Active comparator
GLP 1
Semaglutide 2.4 mg weekly: 16 weeks before conversion, held 7 days before surgery, restarted 4 weeks after surgery, continued to 12 months after surgery.
Placebo comparator
Placebo
Matched placebo on the identical schedule.
Primary outcomes1
Outcomes the sponsor listed as primary.
Percentage total weight loss
Time frame · Baseline till 30 months
Registry description
Measured in kilograms at month 18 after randomization. Baseline is the randomization weight.
Secondary outcomes(12)
BMI change
Time frame · 0, 3, 6, 9, 12 months
Registry description
Equation: BMI = weight (In kilograms) / \[height (In meters)\]\^2
change in HbA1c
Time frame · 0, 6, 12 months
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 · 0, 6, 12 months
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 · 0, 6, 12 months
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.)
Operative time
Time frame · At the time or during surgery
Registry description
From the start till the end of the surgery measured in minutes
Intraoperative adverse events
Time frame · At the time or during surgery
Registry description
Adverse intraoperative events (AIEs) occur in approximately 3% to 7% of bariatric surgeries and increase the relative risk of overall postoperative complications by about 90%. Organ Injuries: Unintentional lacerations or punctures to the liver, spleen, stomach, intestines, or major blood vessels during trocar placement or dissection. Intraoperative Bleeding: Significant hemorrhage from staple lines, mesentery, or the abdominal wall requiring intervention or transfusion. Anastomosis and Staple Line Issues: Leaks, bleeding, or technical difficulties during the creation of pouches or connections (such as in a Roux-en-Y Gastric Bypass), identified via intraoperative leak tests. Equipment Malfunction: Failures involving laparoscopic staplers, cameras, insufflation systems, or energy devices. Anesthesia-Related Events: Severe hemodynamic instability, difficult airway management, or allergic reactions linked to medications.
30-day complications
Time frame · postoperative till 30 days
Registry description
The Clavien-Dindo Classification grades 30-day postoperative complications based on the level of medical or surgical therapy needed to treat them. Grade I: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions. Grade II: Requiring pharmacological treatment with drugs other than those allowed for Grade I, including blood transfusions and total parenteral nutrition. Grade III: Requiring surgical, endoscopic, or radiological intervention. Grade IIIa: Intervention not under general anesthesia. Grade IIIb: Intervention under general anesthesia. Grade IV: Life-threatening complication (including central nervous system complications) requiring intermediate care or intensive care unit (ICU) management. Grade V: Death of a patient.
change in GerdQ score
Time frame · 0, 6, 12 months
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.
change in IWQOL-Lite-CT total and domain scores
Time frame · 0, 6, 12 months
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 fat mass and lean soft tissue mass
Time frame · 0, 6, 12 months
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.
Hand-grip strength
Time frame · 0, 6, 12 months
Registry description
A hand grip strength test measures the maximum force of your hand and forearm muscles using a portable device called a handgrip dynamometer. Position yourself: Sit up straight with your feet flat on the floor. Place your arm by your side with your elbow bent at a 90-degree angle and your wrist in a neutral position. Hold the device: Adjust the handle so it fits comfortably in your hand. Squeeze hard: Squeeze the handles as hard as you can for about 3 to 5 seconds without moving your arm or resting the device against your body. Repeat trials: Take three measurements for each hand, resting for 15 to 30 seconds between attempts. Use either the highest score or the average of the trials. A normal hand grip strength score typically ranges from 40 to 56 kg (88 to 123 lbs) for adult men and 25 to 36 kg (55 to 79 lbs) for adult women aged 20-29.
Safety of the drug phase
Time frame · Baseline till 30 months
Registry description
all adverse events, with events of special interest: pancreatitis, gallstones, severe gastrointestinal intolerance, hypoglycemia, dumping, aspiration at induction, venous thromboembolism, mortality.
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.
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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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