Not 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

Lead sponsor

General Committee of Teaching Hospitals and Institutes, Egypt

Asset

Semaglutide

GLP-1 agonist

Listed sites

Recruiting sites

Estimated enrollment

100

Study population

Obesity / overweight

Eligibility highlights

Primary endpoint

•Mean operative difficulty score

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07859137

Org study IDBRIDGE Trial

Timeline

Milestones

Study first posted2026-10-05actual

Last update posted2026-10-05actual

Study start2026-10estimated (month precision)

Primary completion2028-11estimated (month precision)

Study completion2028-11estimated (month precision)

Assets

Investigational agents

Semaglutide

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age18 Years

Maximum age60 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•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

Exclusion criteria

•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

Endpoints (12)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Weight & body composition

Safety / tolerability / PK

Weight & body composition

2 endpoints

Secondary/protocol endpoint

Preoperative percentage of total weight loss (%TWL)

Time frame:from week 0 to surgery

descriptive

Secondary/protocol endpoint

Waist circumference

Time frame:At week 0, week 16, and month 12

descriptive

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Intraoperative adverse events

Time frame:At the time or during surgery

descriptive

Secondary/protocol endpoint

Safety of the drug phase

Time frame:From enrollment until 16 weeks

descriptive

Other (unclassified)

8 endpoints

Primary/protocol endpoint/low confidence

Mean operative difficulty score

Time frame:At the time or during surgery

descriptive