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Clinical Trials in Japan / NCT07633639
Recruiting Not applicable

GLP-1 Therapy After Bariatric Surgery in Chinese Patients With Obesity

NCT07633639 · tracked via the Priya Life Science Japan tracker
Phase
Not applicable
Started
2026-05-01
Last updated
2026-06-08

Condition(s) studied

Obesity

Investigational drug(s) / intervention(s)

LSG-Semaglutide groupLSG-Mazdutide groupLSG-Tirzepatide groupLSG group

LSG-Semaglutide group: 1. Basic Treatment Measures Within 0-30 days after sleeve gastrectomy, all patients received very low-calorie enteral nutrition powder (100 kcal/day). From 30 to 90 days post-surgery, a low-energy diet (400 kcal/day) was provided. Beyond 90 days post-surgery, a calorie-restricted diet was implemented (1,500 kcal/day for men and 1,200 kcal/day for women). 2. In addition to laparoscopic sleeve gastrectomy and postoperative basic nutritional counseling,the LSG-Semaglutide group received subcutaneous semaglutide injections from 1 to 6 months postoperatively.The specific protocol was as follows:In the intervention group, semaglutide treatment was initiated at 1 month after LSG. The starting dose was 0.25 mg per week and was subsequently titrated up based on individual patient response to a maximum maintenance dose of 2.4 mg per week. The treatment continued until the completion of the 6-month postoperative period.

LSG-Mazdutide group: 1. Basic Treatment Measures Within 0-30 days after sleeve gastrectomy, all patients received very low-calorie enteral nutrition powder (100 kcal/day). From 30 to 90 days post-surgery, a low-energy diet (400 kcal/day) was provided. Beyond 90 days post-surgery, a calorie-restricted diet was implemented (1,500 kcal/day for men and 1,200 kcal/day for women). 2. In addition to laparoscopic sleeve gastrectomy and postoperative basic nutritional counseling,the LSG-Mazdutide group received subcutaneous Mazdutide injections from 1 to 6 months postoperatively.The specific protocol was as follows:In the intervention group, Mazdutide treatment was initiated at 1 month after LSG. The starting dose was 2 mg per week and was subsequently titrated up based on individual patient response to a maximum maintenance dose of 6 mg per week. The treatment continued until the completion of the 6-month postoperative period.

LSG-Tirzepatide group: 1. Basic Treatment Measures Within 0-30 days after sleeve gastrectomy, all patients received very low-calorie enteral nutrition powder (100 kcal/day). From 30 to 90 days post-surgery, a low-energy diet (400 kcal/day) was provided. Beyond 90 days post-surgery, a calorie-restricted diet was implemented (1,500 kcal/day for men and 1,200 kcal/day for women). 2. In addition to laparoscopic sleeve gastrectomy and postoperative basic nutritional counseling,the LSG-Tirzepatide group received subcutaneous Tirzepatide injections from 1 to 6 months postoperatively.The specific protocol was as follows:In the intervention group, Tirzepatide treatment was initiated at 1 month after LSG. The starting dose was 2.5 mg per week and was subsequently titrated up based on individual patient response to a maximum maintenance dose of 10 mg per week. The treatment continued until the completion of the 6-month postoperative period.

LSG group: 1. Basic Treatment Measures Within 0-30 days after sleeve gastrectomy, all patients received very low-calorie enteral nutrition powder (100 kcal/day). From 30 to 90 days post-surgery, a low-energy diet (400 kcal/day) was provided. Beyond 90 days post-surgery, a calorie-restricted diet was implemented (1,500 kcal/day for men and 1,200 kcal/day for women). 2. Observation Group: Received only basic nutritional recommendation interventions after surgery.

Study summary

Obese patients exhibit considerable heterogeneity and complex comorbidities, making long-term effective management challenging with monotherapy. While bariatric surgery remains the most effective weight-loss intervention, postoperative weight regain and metabolic deterioration remain significant concerns. glucagon-like peptide-1 receptor agonists (GLP-1RA) offer distinct advantages for weight loss and metabolic control, and their combination with surgery may produce synergistic effects. This study investigates the efficacy and safety of bariatric surgery combined with adjuvant GLP-1 receptor agonist therapy for Chinese patients with obesity.

Eligibility

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
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).

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
China-Japan Friendship Hospital Beijing China Recruiting

More China-Japan Friendship Hospital trials in Japan

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07633639 on ClinicalTrials.gov ↗ ← All trials in Japan