Trial · Interventional
Not yet recruitingPhase 4Registry dataSemaglutide Before Primary Metabolic and Bariatric Surgery in Patients With BMI 60 kg/m² or Higher
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 · Double masking
- Countries
1 country
Egypt
- Start
- Oct 2026 (estimated)
- Primary completion
- Nov 2028 (estimated)
- Completion
- Nov 2028 (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 Before Primary Metabolic and Bariatric Surgery in Patients With BMI 60 kg/m² or Higher
NCT07859137est. Oct 2026 to est. Nov 2028
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
Patients with BMI 60 kg/m² or higher are the hardest operations in bariatric surgery. Thick abdominal wall, massive hepatomegaly, reduced working space, fragile fatty tissue, higher conversion and complication rates. Every bariatric surgeon knows this group. Almost no trial recruits it. The standard answer is a short liver-reduction diet before surgery. It helps, but the effect is modest, hard to tolerate, and short-lived. GLP-1-based drugs now produce far larger and better-tolerated weight loss and are already being given before surgery in routine practice, without trial evidence. Retrospective series show more preoperative weight loss and no obvious harm, and no more than that (Obesity Research \& Clinical Practice 2026). A 2023 review of drugs on the surgical waiting list found that GLP-1 receptor agonists had never been evaluated for the preoperative indication at all. Two registered trials are now adjacent to this question, and we cite both. The PreMO pilot randomizes 50 patients to open-label preoperative tirzepatide versus standard care, with tissue inflammation as the scientific focus (PMID 41643256; NCT06721507). A three-arm trial before one-anastomosis gastric bypass compares tirzepatide, ketogenic diet, and standard care, with weight loss at one year as primary (NCT07622992). Neither is blinded. Neither recruits BMI 60 and above. Neither measures whether the drug actually makes the operation easier and safer. The 2024 IFSO international consensus reached 100% agreement that evidence is insufficient to recommend routine preoperative medication, that use must be individualized, and that more research on benefits, risks, and outcomes is required; it also agreed, at 97%, that adequate protein and resistance exercise must accompany any preoperative drug treatment (PMID 39612579). This trial is the research that consensus calls for, and its preoperative program is built to the 97% requirement.
Interventions
- Semaglutide weekly injectionDrug
- PlaceboDrug
Arms2
Active comparator
GLP 1
Semaglutide escalated to 2.4 mg weekly over 16 weeks before surgery, held 7 days before operation.
Placebo comparator
Placebo
Matched placebo pens on the identical schedule
Primary outcomes1
Outcomes the sponsor listed as primary.
Mean operative difficulty score
Time frame · At the time or during surgery
Registry description
Each anonymized video is rated independently by three blinded expert bariatric surgeons on five domains (liver size and handling; exposure; tissue fragility and adhesions; bleeding tendency; overall difficulty), each 1 to 5, total 5 to 25. The mean of the three raters is the patient's score. Raters are trained on a calibration set of 10 non-trial videos before unblinded rating begins; inter-rater reliability (ICC) is reported.
Secondary outcomes(11)
Preoperative percentage of total weight loss (%TWL)
Time frame · from week 0 to surgery
Registry description
Total weight loss measured in Kilograms
Operative time, skin to skin
Time frame · At the time or during surgery
Registry description
From the start till the end of the surgery measured in minutes
Estimated blood loss
Time frame · At the time of surgery
Registry description
Bleeding intraoperative measured in milliliters
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.
Conversion to open
Time frame · At the time or during surgery
Registry description
Number of cases converted from laparoscopic to open surgery.
Number of stapler loads
Time frame · At the time or during surgery
Registry description
Number of stapler loads in each case.
30-day complications
Time frame · From surgery until 12 months postoperative
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.
Liver span
Time frame · At week 0 and week 16
Registry description
By standardized ultrasound A normal adult liver span measured by ultrasound along the midclavicular line is typically less than 15 to 16 cm in the craniocaudal (vertical) dimension. Right Lobe (Craniocaudal): Usually 13 to 15 cm; values above 15-16 cm often suggest hepatomegaly (enlarged liver). Left Lobe (Width/Thickness): Usually less than 7 cm.
Hand-grip strength
Time frame · At week 0, week 16, and month 12
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.
Waist circumference
Time frame · At week 0, week 16, and month 12
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.
Safety of the drug phase
Time frame · From enrollment until 16 weeks
Registry description
Of semaglutide including gastrointestinal adverse events and any aspiration event at induction.
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 60 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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