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← All trials/NCT07859163

Not 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

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

-

Estimated enrollment

100

Study population

Obesity / overweight

Eligibility highlights

-

Primary endpoint

•Percentage total weight loss

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 IDNCT07859163
Org study IDSANDWICH Trial

Timeline

Milestones

Study first posted2026-10-05actual
Last update posted2026-10-05actual
Study start2026-10estimated (month precision)
Primary completion2029-04estimated (month precision)
Study completion2029-04estimated (month precision)

Assets

Investigational agents

Semaglutide

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•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.

Exclusion criteria

•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.
•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.

Endpoints (13)

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)
5
Weight & body composition
3
Cardiometabolic biomarkers
2
Safety / tolerability / PK
2
Glycemic / diabetes
1

Weight & body composition

3 endpoints
Primary/protocol endpoint

Percentage total weight loss

Time frame:Baseline till 30 months

descriptive

Secondary/protocol endpoint

BMI change

Time frame:0, 3, 6, 9, 12 months

descriptive

Secondary/protocol endpoint

change in fat mass and lean soft tissue mass

Time frame:0, 6, 12 months

change from baseline, improvement

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

change in HbA1c

Time frame:0, 6, 12 months

change from baseline, improvement

Cardiometabolic biomarkers

2 endpoints
Secondary/protocol endpoint

systolic and diastolic blood pressure

Time frame:0, 6, 12 months

descriptive

Secondary/protocol endpoint

total cholesterol, LDL, HDL, and triglycerides

Time frame:0, 6, 12 months

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:Baseline till 30 months

descriptive

Other (unclassified)

5 endpoints
Secondary/protocol endpoint/low confidence

Operative time

Time frame:At the time or during surgery

descriptive

Secondary/protocol endpoint/low confidence

30-day complications

Time frame:postoperative till 30 days

descriptive

Secondary/protocol endpoint/low confidence

change in GerdQ score

Time frame:0, 6, 12 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

change in IWQOL-Lite-CT total and domain scores

Time frame:0, 6, 12 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Hand-grip strength

Time frame:0, 6, 12 months

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateNovember 5, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.