← Trials/Trial dossier/NCT07633639
GLP-1 Therapy After Bariatric Surgery in Chinese Patients With Obesity
The Efficacy and Safety of Adjuvant GLP-1 Receptor Agonist Therapy Following Metabolic Bariatric Surgery in Chinese Patients With Obesity: A Prospective, Monocentric, Stratified Randomized Controlled Trial
Lead sponsor
Assets
Mazdutide / Semaglutide / Tirzepatide
Listed sites
1
Recruiting sites
1
Enrollment
200
estimated
Study population
Bariatric Surgery, Obesity / overweight
Key I/E criterion
•BMI ≥30
Primary endpoint
•Percentage of weight loss
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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Patients undergoing initial laparoscopic sleeve gastrectomy (LSG).
2. obesity:BMI ≥30 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:
5.1Advanced hepatic/renal dysfunction (Child-Pugh C or eGFR <30 mL/min/1.73m²). 5.2Active malignancy (except non-melanoma skin cancers). 5.3Autoimmune disorders requiring immunosuppression. 5.4Uncontrolled psychiatric conditions (e.g., active psychosis, severe depression).
Endpoints (27)
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
4 endpointsPercentage of weight loss.
Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
descriptive
Weight in kilograms
Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
descriptive
Waist circumference in centimeters
Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
descriptive
Visceral fat area
Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
descriptive
Glycemic / diabetes
4 endpointsFasting blood glucose
Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
descriptive
Average blood glucose from continuous glucose monitoring
Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
descriptive
Postprandial 2-hour blood glucose
Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
descriptive
HbA1c
Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
descriptive
MASH / liver
3 endpointsAlanine Aminotransferase(ALT)
Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
descriptive
Aspartate Aminotransferase(AST)
Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
descriptive
Liver Stiffness Measurement(LSM)
Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
descriptive
Renal / kidney
3 endpointsSerum creatinine
Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
descriptive
Glomerular filtration rate
Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
ratio, improvement
urine microalbumin-to-creatinine ratio (ACR)
Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
ratio, improvement
Cardiometabolic biomarkers
5 endpointsBlood pressure
Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
descriptive
Total cholesterol
Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
descriptive
Low-Density Lipoprotein(LDL)
Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
descriptive
Triglycerides
Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
descriptive
uric acid(UA)
Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
descriptive
Other (unclassified)
8 endpointsHip circumference in centimeters
Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
descriptive
Urinary microalbumin
Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
descriptive
body fat percentage(BFP)
Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
descriptive
Muscle mass in kilograms
Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
descriptive
Body fat percentage
Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
descriptive
lean body mass (LBM)
Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
descriptive
lean body mass percentage (LBMP)
Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
descriptive
Controlled Attenuation Parameter(CAP)
Time frame:Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
descriptive
Provenance
Sources
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.