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

NCT07633639 | Recruiting

• 1 other identifier: 2026-CJH-OBE
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity

Keywords

obesity; Glucagon-Like Peptide-1 Receptor Agonists; Metabolic Bariatric Surgery; Semaglutide; Mazdutide; Tirzepatide

Outcome Measures

Primary Outcomes (1)

• Percentage of weight loss.

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

Secondary Outcomes (26)

• Weight in kilograms

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

• Waist circumference in centimeters

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

• Hip circumference in centimeters

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

• Blood pressure

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

• Serum creatinine

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

Study Arms (4)

LSG-Semaglutide group

EXPERIMENTAL

Names for Surgery: Laparoscopic Sleeve Gastrectomy. Names for drugs: Semaglutide. Dosage: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. Frequency: Once per week. Duration: The treatment continued until the completion of the 6-month postoperative period.

Combination Product: LSG-Semaglutide group

LSG-Mazdutide group

EXPERIMENTAL

Names for Surgery: Laparoscopic Sleeve Gastrectomy. Names for drugs:Mazdutide. Dosage: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. Frequency: Once per week. Duration: The treatment continued until the completion of the 6-month postoperative period.

Combination Product: LSG-Mazdutide group

LSG-Tirzepatide group

EXPERIMENTAL

Names for Surgery: Laparoscopic Sleeve Gastrectomy. Names for drugs:Tirzepatide. Dosage: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. Frequency: Once per week. Duration: The treatment continued until the completion of the 6-month postoperative period.

Combination Product: LSG-Tirzepatide group

LSG group

OTHER

Names for Surgery: Laparoscopic Sleeve Gastrectomy. Names for drugs: N/A. Observation Group: Received only basic nutritional recommendation interventions after surgery.

Procedure: LSG group

Interventions

LSG-Semaglutide group COMBINATION_PRODUCT

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-Semaglutide group

LSG-Mazdutide group COMBINATION_PRODUCT

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-Mazdutide group

LSG-Tirzepatide group COMBINATION_PRODUCT

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-Tirzepatide group

LSG group PROCEDURE

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.

LSG group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients undergoing initial laparoscopic sleeve gastrectomy (LSG).
• obesity:BMI ≥30 kg/m².
• Metabolic comorbidities: Diagnosis of metabolic syndrome or type 2 diabetes mellitus (T2DM) meeting standard criteria.
• Age range: 18-60 years (inclusive).
• Informed consent: Willing participation with documented consent.

You may not qualify if:

• Recent GLP-1RA use: Treatment with GLP-1 receptor agonists within 6 months preoperatively.
• Prior bariatric surgery: History of any metabolic/bariatric surgical procedure.
• Postoperative complications: Requiring reoperation for severe complications (e.g., hemorrhage, anastomotic leak).
• Non-indicated candidates: Patients not meeting standard bariatric surgery indications.
• Significant comorbidities:
• Advanced 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).

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yishan Huang, Ph.D

CONTACT

+8618612256920; yuanwen0920@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: The decision to add GLP-1RAs as adjuvant therapy after sleeve gastrectomy, including which specific drug to use, is made by the attending physicians based on each patient's clinical condition. The researchers do not intervene in the treatment assignment for any patient.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Model Details: Non-randomized assignment: A total of 200 eligible patients were assigned to either the Semaglutide(n=50) 、Mazdutide (n=50)、Tirzepatide(n=50)、control(n=50) group. 1. All participants underwent sleeve gastrectomy. 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. Exposure Factor: GLP-1RA was initiated at 1 month after surgery. 3. Grouping 3.1Control Group: Received only basic nutritional recommendation interventions after surgery. 3.2Treatment Group: Initiated Semaglutide,Mazdutide,Tirzepatide at 1 month after surgery.

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: June 8, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: June 8, 2026

Record last verified: 2026-05

Locations

CN (1)