Semaglutide Given Before and After Conversion of Sleeve Gastrectomy to Roux-en-Y Gastric Bypass for Recurrent Weight Gain

NCT07859163 · tracked via the Priya Life Science Egypt tracker

Sponsor

General Committee of Teaching Hospitals and Institutes, Egypt

Phase

Phase 4

Started

2026-10

Last updated

2026-10-05

Condition(s) studied

Morbid Obesity

Investigational drug(s) / intervention(s)

Semaglutide weekly injection →Placebo

Semaglutide weekly injection: Weekly subcutaneous injections from identical, pharmacy-labelled pens. The active arm receives semaglutide 2.4 mg. Escalation: 0.25, 0.5, 1.0, 1.7, 2.4 mg at 4-week steps. If 2.4 mg is not tolerated, the patient stays on the highest tolerated dose of at least 1.0 mg. Patients who cannot tolerate 1.0 mg stop injections but stay in the trial and are analyzed in their arm.

Placebo: Weekly subcutaneous injections from identical, pharmacy-labelled pens. The placebo arm receives matched placebo. Escalation: 0.25, 0.5, 1.0, 1.7, 2.4 mg at 4-week steps. If 2.4 mg is not tolerated, the patient stays on the highest tolerated dose of at least 1.0 mg. Patients who cannot tolerate 1.0 mg stop injections but stay in the trial and are analyzed in their arm.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

Inclusion Criteria: * SG at least 2 years before screening. * Recurrent weight gain meeting the international Delphi consensus definition. Operational entry threshold for this trial: regain of at least 20% of the maximal weight lost, measured from nadir. * BMI of 35 kg/m² or more, or 30 kg/m² or more with at least one obesity-associated disease, and accepted for conversion to RYGB by the multidisciplinary team. * Upper endoscopy and contrast imaging completed. * Able to give written informed consent. Exclusion Criteria: * Anatomy. These patients need surgery regardless of drug response, so randomizing them is not ethical. They are operated outside the trial. This is the operational form of the rule: anatomical cause, direct surgery; no anatomical cause, eligible for the trial. * Staple-line leak or gastric fistula. * Sleeve stenosis or axial twist. * Hiatal hernia larger than 3 cm. * Los Angeles grade C or D esophagitis, or Barrett's esophagus. * Drug and general safety * GLP-1 receptor agonist use within the last 6 months, or previous intolerance. * History of pancreatitis. * Personal or family history of medullary thyroid carcinoma or MEN2. * Type 1 diabetes; eGFR below 30 mL/min/1.73 m²; active malignancy. * Pregnancy, breastfeeding, or pregnancy plans during the study. Women of childbearing potential must use reliable contraception. Per current labeling and the 2026 Standards, obesity pharmacotherapy is stopped at least 2 months before any planned conception. * Uncontrolled psychiatric disease or active substance use disorder. * Current smoking, unless cessation is completed before surgery per unit policy. * Any other anti-obesity medication within the last 3 months.

Primary outcome measure(s)

Percentage total weight loss — Baseline till 30 months
Measured in kilograms at month 18 after randomization. Baseline is the randomization weight.

Trial sites (1)

Facility	City	Region	Status
The surgical department of Medical Research Institute Hospital, Alexandria University	Alexandria	Egypt

More General Committee of Teaching Hospitals and Institutes, Egypt trials in Egypt

Immediate Versus Criterion-triggered Semaglutide for Suboptimal Clinical Response One Year After Primary Metabolic and Bariatric Surgery Starting soon

Tapered Versus Abrupt Discontinuation of Semaglutide After Treatment of Recurrent Weight Gain or Suboptimal Response Following Metabolic and Bariatric Surgery Starting soon

Comparing Revisional Laparoscopic Roux-en-Y Gastric Bypass Versus Ringed Revisional Roux-en-Y Gastric Bypass After Laparoscopic Sleeve Gastrectomy Recruiting

Semaglutide Before Primary Metabolic and Bariatric Surgery in Patients With BMI 60 kg/m² or Higher Starting soon

D2 Versus D3 Dissection in Laparoscopic Right Hemicolectomy Starting soon

Other trials for the same condition

Immediate Versus Criterion-triggered Semaglutide for Suboptimal Clinical Response One Year After Primary Metabolic and Bariatric Surgery Starting soon

Interaction Between Head/Neck Position and C-MAC Blade Geometry on Videolaryngoscopic Intubation in Morbidly Obese Patients: A Randomized Controlled Trial Active, not recruiting

Tapered Versus Abrupt Discontinuation of Semaglutide After Treatment of Recurrent Weight Gain or Suboptimal Response Following Metabolic and Bariatric Surgery Starting soon

Semaglutide Before Primary Metabolic and Bariatric Surgery in Patients With BMI 60 kg/m² or Higher Starting soon

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

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07859163 on ClinicalTrials.gov ↗ ← All trials in Egypt