NCT07859163Not yet recruitingPhase 4
Semaglutide Given Before and After Conversion of Sleeve Gastrectomy to Roux-en-Y Gastric Bypass for Recurrent Weight Gain
Semaglutide Given Before and After Conversion of Sleeve Gastrectomy to Roux-en-Y Gastric Bypass for Recurrent Weight Gain: a Randomized, Double-blind, Placebo-controlled Trial
Source: ClinicalTrials.gov · Last updated 5 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 29 Sept 2026
- Start date
- Oct 2026
- Primary completion date
- Apr 2029
- Lead sponsor
- General Committee of Teaching Hospitals and Institutes, Egypt
- Diseases
- Obesity
- NCT number
- NCT07859163
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 100
- From Oct 2026 to the primary completion date, Apr 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Lab values
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The surgical department of Medical Research Institute Hospital, Alexandria University Coordinator of this site? Confirm its status | Alexandria | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.