Morbid ObesityPhase 4NCT07859137
Semaglutide Before Primary Metabolic and Bariatric Surgery in Patients With BMI 60 kg/m² or Higher
A Phase 4 study testing Semaglutide weekly injection in people with Morbid Obesity, run by General Committee of Teaching Hospitals and Institutes, Egypt at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Semaglutide weekly injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2026to Nov 2028
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- BMI 60 kg/m² or higher at first surgical assessment
- Accepted by the multidisciplinary team for primary laparoscopic SG or RYGB
- Able to self-inject and consent
Who cannot join
- Any previous bariatric or major upper abdominal surgery
- GLP-1-based therapy within the previous 6 months
- Type 1 diabetes
- Pregnancy or conception planned within the study (obesity pharmacotherapy is stopped at least 2 months before any planned conception, per current labeling and the 2026 Standards)
- Personal or family history of medullary thyroid carcinoma or MEN2
- History of pancreatitis
- Active severe gastrointestinal disease
- Any condition making 16 weeks of delay unsafe in the judgment of the surgical team
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
The surgical department of Medical Research Institute Hospital, Alexandria University
Alexandria, 21531
Mohamed Hany Ashour, Professor, MD, +201002600970, mohamed.ashour@alexu.edu.eg
Mohamed Hany Ashour, Professor, MD, mohamed.ashour@alexu.edu.eg
About this study
Official title: Semaglutide Before Primary Metabolic and Bariatric Surgery in Patients With BMI 60 kg/m² or Higher: a Randomized, Double-blind, Placebo-controlled Trial of Surgical Feasibility and Safety
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.
Read the detailed description
Operative difficulty can be measured properly. Our group's surgical video assessment methodology makes it the primary endpoint: every operation is recorded in full, anonymized, and rated independently by three blinded expert surgeons using a predefined five-domain instrument (liver size and handling, quality of exposure, tissue fragility and adhesions, bleeding tendency, overall difficulty). The surgeon cannot be blinded to the patient's habitus on the table; the raters watching the video are blinded to allocation. This gives a blinded, objective primary endpoint in an unblindable operation.
Perioperative drug handling follows the 2025 multisociety guidance: last injection at least 7 days before surgery, 24 hours of clear fluids, and full-stomach precautions at induction (PMID 39480373). This is written into the protocol, not left to the anesthesia team on the day.
Unlike our SANDWICH population, these patients will not lose their surgical indication. From BMI 60, even an excellent 16-week response leaves the patient far above every operative threshold. The deferral rule is retained for completeness, and every patient is analyzed in the assigned arm, but exit from surgery is not a realistic outcome here. This trial is about making an unavoidable operation better.
Both answers change practice. If the drug makes surgery measurably easier and safer, a 16-week semaglutide bridge becomes the standard pathway for the highest-BMI patients, in line with the direction of the 2024 IFSO position on combining pharmacotherapy with surgery (PMID 39400870). If it does not, the trial stops an expensive drift in practice before it hardens into habit.
Question: In adults with BMI 60 kg/m² or higher undergoing primary laparoscopic SG or RYGB, does 16 weeks of preoperative semaglutide make the operation objectively easier and safer than the standard preoperative program alone? Primary hypothesis. Preoperative semaglutide lowers the blinded video-rated operative difficulty score by at least 0.65 standard deviations.
Secondary hypothesis. Preoperative semaglutide shortens operative time, reduces intraoperative adverse events, and does not increase postoperative complications.
- Conditions
- Morbid Obesity
- Being tested
- Semaglutide weekly injection, Placebo
- Keywords
- Semaglutide, primary metabolic and bariatric surgery, bariatric surgery, BMI 60 kg/m² or higher
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide weekly injectionDrug
Weeks 0 to 16: semaglutide 0.25, 0.5, 1.0, 1.7, then 2.4 mg weekly in 4-weekly steps, or matched placebo. Slower escalation allowed for tolerance; minimum acceptable plateau 1.7 mg.
Last injection at least 7 days before surgery. Clear fluids for 24 hours before induction. Anesthesia manages every trial patient with full-stomach precautions.
Surgery in weeks 17 to 18: laparoscopic SG or RYGB by the standardized unit technique, chosen and declared before randomization. Every operation recorded in full.
PlaceboDrug
Matched placebo pens on the identical schedule
| Study group | Role | What they receive |
|---|---|---|
| GLP 1 | Active comparator | Semaglutide escalated to 2.4 mg weekly over 16 weeks before surgery, held 7 days before operation. Receives: Drug: Semaglutide weekly injection |
| Placebo | Placebo comparator | Matched placebo pens on the identical schedule Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean operative difficulty score
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.
Measured: At the time or during surgery
Secondary outcomes (11)
Preoperative percentage of total weight loss (%TWL)
Total weight loss measured in Kilograms
Measured: from week 0 to surgery
Operative time, skin to skin
From the start till the end of the surgery measured in minutes
Measured: At the time or during surgery
Estimated blood loss
Bleeding intraoperative measured in milliliters
Measured: At the time of surgery
Intraoperative adverse events
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.
Measured: At the time or during surgery
Conversion to open
Number of cases converted from laparoscopic to open surgery.
Measured: At the time or during surgery
Number of stapler loads
Number of stapler loads in each case.
Measured: At the time or during surgery
30-day complications
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.
Measured: From surgery until 12 months postoperative
Liver span
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.
Measured: At week 0 and week 16
Hand-grip strength
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.
Measured: At week 0, week 16, and month 12
Waist circumference
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.
Measured: At week 0, week 16, and month 12
Safety of the drug phase
Of semaglutide including gastrointestinal adverse events and any aspiration event at induction.
Measured: From enrollment until 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Committee of Teaching Hospitals and Institutes, Egypt
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mohamed Hany Ashour, General Committee of Teaching Hospitals and Institutes, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07859137
- Sponsor's protocol ID
- BRIDGE Trial
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes