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NCT07859137Not yet recruitingPhase 4

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

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

Source: ClinicalTrials.gov · Last updated 5 Oct 2026

Brief summary (registry, in English)

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.

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
Nov 2028
Lead sponsor
General Committee of Teaching Hospitals and Institutes, Egypt
Diseases
Obesity
NCT number
NCT07859137

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 100
  • From Oct 2026 to the primary completion date, Nov 2028
  • 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, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Any previous bariatric or major upper abdominal surgery
  • GLP-1-based therapy within the previous 6 months
  • 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)

Other illness

  • Type 1 diabetes
  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The surgical department of Medical Research Institute Hospital, Alexandria University
Coordinator of this site? Confirm its status
AlexandriaEgyptUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.