Weight-loss surgery plus GLP-1 medication for severe obesity

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

This trial will test whether adding a GLP‑1 receptor agonist medicine to sleeve gastrectomy helps adults with BMI ≥35 and metabolic conditions keep off weight and improve metabolic health.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: China-Japan Friendship Hospital (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT07336862 on ClinicalTrials.gov

What this trial studies

This phase 1/2 interventional trial compares laparoscopic sleeve gastrectomy alone to sleeve gastrectomy plus adjuvant GLP‑1 receptor agonist therapy in adults with severe obesity and metabolic comorbidities. Eligible participants are primary LSG candidates aged 18–60 with BMI ≥35 kg/m² and metabolic syndrome or type 2 diabetes, and they are assigned to either the BS‑GLP group or the BS group. Investigators will follow weight, glycemic and lipid markers, and safety outcomes over time to measure durability of weight loss and metabolic improvement. Key exclusions include prior bariatric surgery, recent GLP‑1RA use, advanced organ dysfunction, active malignancy, and autoimmune disease requiring immunosuppression to protect safety and reduce confounding.

Who should consider this trial

Good fit: Adults 18–60 years old with BMI ≥35 kg/m² who are primary candidates for laparoscopic sleeve gastrectomy and have metabolic syndrome or type 2 diabetes and have not used GLP‑1 RAs in the prior 6 months.

Not a fit: Patients with advanced hepatic or renal failure, active malignancy, prior bariatric surgery, recent GLP‑1RA treatment, or those requiring reoperation for severe postoperative complications are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, combining surgery with GLP‑1 therapy could produce greater and more durable weight loss and better metabolic control than surgery alone.

How similar studies have performed: Bariatric surgery and GLP‑1 receptor agonists have each shown substantial weight-loss and metabolic benefits on their own, but large randomized long-term trials testing their combined use are still limited.

Eligibility criteria

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)

Where this trial is running

Beijing

• China-Japan Friendship Hospital — Beijing, China (Recruiting)

Study contacts

• Principal investigator: Hua Meng, Ph.D — China-Japan Friendship Hospital
• Study coordinator: Yishan Huang, Ph.D

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