Bariatric Surgery Combined With GLP-1 Receptor Agonists Study

NCT07336862 | Recruiting Phase 1

• 1 other identifier: 2023-KY-339
• 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 single therapies. While bariatric surgery remains the most effective weight-loss intervention, postoperative weight regain and metabolic deterioration require attention. GLP-1 RAs offer distinct advantages for weight and metabolic improvement, and their combined application with surgery may yield synergistic benefits. This study investigates the efficacy and safety of bariatric surgery combined with GLP-1 receptor agonist adjuvant therapy for severe obesity.

Conditions

Obesity

Keywords

obesity; Glucagon-Like Peptide-1 Receptor Agonists; Bariatric Surgery

Outcome Measures

Primary Outcomes (1)

• the Percentage of weight loss

  Through study completion, an average of 1 year, the investigators will observe the Percentage of weight loss.

  1 year

Secondary Outcomes (22)

• Gender

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

• Ethnicity

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

• Height in meters

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

• 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.

Other Outcomes (6)

• body fat percentage(BFP)

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

• Visceral fat area

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

• Muscle mass in kilograms

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

Study Arms (2)

BS-GLP 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: BS-GLP group

BS group

OTHER

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

Procedure: BS group

Interventions

BS-GLP 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 intervention 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.

BS-GLP group

BS 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.

BS group

Eligibility Criteria

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

You may qualify if:

• Primary metabolic surgery candidates: Patients undergoing initial laparoscopic sleeve gastrectomy (LSG)
• obesity:BMI ≥35 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)
• Active malignancy (except non-melanoma skin cancers)
• Autoimmune disorders requiring immunosuppression
• Uncontrolled 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

Study Officials

• Hua Meng, Ph.D

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yishan Huang, Ph.D

CONTACT

18810621201; bucmyishan@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: September 29, 2025
• First Posted: January 13, 2026
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 23, 2026

Record last verified: 2025-09

Locations

CN (1)