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BS-GLP

RecruitingPhase 1, PHASE2

Bariatric Surgery Combined With GLP-1 Receptor Agonists Study

The Efficacy and Safety of Bariatric Surgery Combined With GLP-1 Receptor Agonists for Patients With Severe Obesity: A Prospective, Multicenter Cohort Study

Asset

Semaglutide

GLP-1 agonist

Listed sites

1

Recruiting sites

1

Enrollment

200

estimated

Study population

Bariatric Surgery, Obesity / overweight

Key I/E criterion

BMI ≥35

Primary endpoint

Body weight, % change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07336862
Org study ID2023-KY-339

Timeline

Milestones

Study start2024-01-01actual
Study first posted2026-01-13actual
Last update posted2026-04-23actual
Primary completion2027-12estimated (month precision)
Study completion2027-12estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Bariatric SurgeryObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age60 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Primary metabolic surgery candidates: Patients undergoing initial laparoscopic sleeve gastrectomy (LSG)

2. obesity:BMI ≥35 kg/m²

3. Metabolic comorbidities: Diagnosis of metabolic syndrome or type 2 diabetes mellitus (T2DM) meeting standard criteria

4. Age range: 18-60 years (inclusive)

5. Informed consent: Willing participation with documented consent

Exclusion criteria

1. Recent GLP-1RA use: Treatment with GLP-1 receptor agonists within 6 months preoperatively

2. Prior bariatric surgery: History of any metabolic/bariatric surgical procedure

3. Postoperative complications: Requiring reoperation for severe complications (e.g., hemorrhage, anastomotic leak)

4. Non-indicated candidates: Patients not meeting standard bariatric surgery indications

5. Significant comorbidities:

Advanced hepatic/renal dysfunction (Child-Pugh C or eGFR <30 mL/min/1.73m²)
Active malignancy (except non-melanoma skin cancers)
Autoimmune disorders requiring immunosuppression
Uncontrolled psychiatric conditions (e.g., active psychosis, severe depression)

Endpoints (29)

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

Weight & body composition
11
Cardiometabolic biomarkers
5
Glycemic / diabetes
4
Renal / kidney
4
Other (unclassified)
3
MASH / liver
2

Weight & body composition

11 endpoints
Primary/protocol endpoint

the Percentage of weight loss

Time frame:1 year

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Height in meters

Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

descriptive

Secondary/protocol endpoint

Weight in kilograms

Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Waist circumference in centimeters

Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Hip circumference in centimeters

Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

change from baseline, improvement

Other/protocol endpoint

body fat percentage(BFP)

Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

Total fat mass

descriptive

Other/protocol endpoint

Visceral fat area

Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

Visceral fat, change

change from baseline, improvement

Other/protocol endpoint

Muscle mass in kilograms

Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

Lean mass

descriptive, improvement

Other/protocol endpoint

Body fat percentage

Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

Total fat mass

descriptive, improvement

Other/protocol endpoint

lean body mass (LBM)

Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

Lean mass

descriptive, improvement

Other/protocol endpoint

lean body mass percentage (LBMP)

Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

Lean mass

descriptive

Glycemic / diabetes

4 endpoints
Secondary/protocol endpoint

Fasting blood glucose

Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Average blood glucose from continuous glucose monitoring

Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

descriptive

Secondary/protocol endpoint

Postprandial 2-hour blood glucose

Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

Postprandial glucose

descriptive, improvement

Secondary/protocol endpoint

HbA1c

Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

HbA1c, change

change from baseline, improvement

LOINC 4548-4

MASH / liver

2 endpoints
Secondary/protocol endpoint

Alanine Aminotransferase(ALT)

Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

ALT, change

change from baseline, improvement

LOINC 1742-6

Secondary/protocol endpoint

Aspartate Aminotransferase(AST)

Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

AST, change

change from baseline, improvement

LOINC 1920-8

Renal / kidney

4 endpoints
Secondary/protocol endpoint

Serum creatinine

Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

descriptive

Secondary/protocol endpoint

Glomerular filtration rate

Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

eGFR, change

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Urinary microalbumin and other Urinalysis indexes

Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

descriptive

Secondary/protocol endpoint

urine microalbumin-to-creatinine ratio (ACR)

Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

uACR, change

ratio, improvement

LOINC 9318-7

Cardiometabolic biomarkers

5 endpoints
Secondary/protocol endpoint

Blood pressure

Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

descriptive, improvement

Secondary/protocol endpoint

Total cholesterol

Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Low-Density Lipoprotein(LDL)

Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

High-Density Lipoprotein(HDL)

Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Triglycerides

Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Other (unclassified)

3 endpoints
Secondary/protocol endpoint

Gender

Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

descriptive

Secondary/protocol endpoint

Ethnicity

Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

descriptive

Secondary/protocol endpoint/low confidence

uric acid(UA)

Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.

change from baseline, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 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 July 1, 2026 snapshot.