ObesityPhase 1/2BS-GLPNCT07336862
Bariatric Surgery Combined With GLP-1 Receptor Agonists Study
A Phase 1/2 study testing BS-GLP group and BS group in people with Obesity, run by China-Japan Friendship Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity
- What is being tested?
- BS-GLP group and BS group
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
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- Active malignancy (except non-melanoma skin cancers)
- Autoimmune disorders requiring immunosuppression
- Uncontrolled psychiatric conditions (e.g., active psychosis, severe depression)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing
Yishan Huang, Ph.D, 18810621201, bucmyishan@163.com
About this study
Official title: The Efficacy and Safety of Bariatric Surgery Combined With GLP-1 Receptor Agonists for Patients With Severe Obesity: A Prospective, Multicenter Cohort Study
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.
Read the detailed description
"bariatric surgery is guideline-recommended as an effective obesity treatment. Substantial evidence demonstrates its ability to significantly reduce weight, improve comorbidities like type 2 diabetes (T2DM) and dyslipidemia, and lower cardiovascular risk. However, the significant heterogeneity and complex comorbidity profiles among obese patients challenge long-term effective management with single therapeutic approaches. While currently the most effective weight-loss intervention, bariatric surgery requires attention to issues such as postoperative weight regain and metabolic deterioration.
In parallel, Glucagon-like peptide-1 receptor agonists (GLP-1RA) have demonstrated significant efficacy in obesity management. Agents like semaglutide promote weight loss and metabolic improvement through mechanisms including insulin secretion promotion, appetite suppression, delayed gastric emptying, and enhanced satiety.
Given the distinct advantages of both bariatric surgery and GLP-1RA therapy in weight and metabolic control, this study will combine these modalities into a comprehensive treatment strategy. The investigators will compare the long-term safety and effectiveness of different combination regimens for weight management and metabolic improvement in patients with severe obesity."
- Conditions
- Obesity
- Being tested
- BS-GLP group, BS group
- Keywords
- obesity, Glucagon-Like Peptide-1 Receptor Agonists, Bariatric Surgery
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BS-GLP groupCombination product
- 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).
- 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 groupProcedure or surgery
- 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).
- Observation Group: Received only basic nutritional recommendation interventions after surgery.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: BS group |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Percentage of weight loss
Through study completion, an average of 1 year, the investigators will observe the Percentage of weight loss.
Measured: 1 year
Secondary outcomes (22)
Gender
Measured: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Ethnicity
Measured: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Height in meters
Measured: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Weight in kilograms
Measured: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Waist circumference in centimeters
Measured: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Hip circumference in centimeters
Measured: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Blood pressure
Measured: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Serum creatinine
Measured: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Glomerular filtration rate
Measured: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Fasting blood glucose
Measured: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Average blood glucose from continuous glucose monitoring
Measured: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Postprandial 2-hour blood glucose
Measured: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
HbA1c
Measured: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Urinary microalbumin and other Urinalysis indexes
Measured: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Total cholesterol
Measured: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Low-Density Lipoprotein(LDL)
Measured: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
High-Density Lipoprotein(HDL)
Measured: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Triglycerides
Measured: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Alanine Aminotransferase(ALT)
Measured: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Aspartate Aminotransferase(AST)
Measured: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
urine microalbumin-to-creatinine ratio (ACR)
Measured: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
uric acid(UA)
Measured: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start1 Jan 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hua Meng, China-Japan Friendship Hospital
- Investigators
- Hua Meng, Ph.D, Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07336862
- Sponsor's protocol ID
- 2023-KY-339
- Acronym
- BS-GLP
- Status last verified
- Sep 2025
- First submitted
- 29 Sep 2025
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Bariatric Surgery Combined With GLP-1 Receptor Agonists for Patients With Severe Obesity: A Prospective, Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT07336862
- Acronym / sponsor ID
- BS-GLP / 2023-KY-339
- Conditions
- Obesity
- Keywords
- obesity, Glucagon-Like Peptide-1 Receptor Agonists, Bariatric Surgery
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
"bariatric surgery is guideline-recommended as an effective obesity treatment. Substantial evidence demonstrates its ability to significantly reduce weight, improve comorbidities like type 2 diabetes (T2DM) and dyslipidemia, and lower cardiovascular risk. However, the significant heterogeneity and complex comorbidity profiles among obese patients challenge long-term effective management with single therapeutic approaches. While currently the most effective weight-loss intervention, bariatric surgery requires attention to issues such as postoperative weight regain and metabolic deterioration.
In parallel, Glucagon-like peptide-1 receptor agonists (GLP-1RA) have demonstrated significant efficacy in obesity management. Agents like semaglutide promote weight loss and metabolic improvement through mechanisms including insulin secretion promotion, appetite suppression, delayed gastric emptying, and enhanced satiety.
Given the distinct advantages of both bariatric surgery and GLP-1RA therapy in weight and metabolic control, this study will combine these modalities into a comprehensive treatment strategy. The investigators will compare the long-term safety and effectiveness of different combination regimens for weight management and metabolic improvement in patients with severe obesity."
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BS-GLP group | Experimental | Combination Product: BS-GLP groupNames 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. |
| BS group | Other | Procedure: BS groupNames for Surgery: Laparoscopic Sleeve Gastrectomy. Names for drugs: N/A. Observation Group: Received only basic nutritional recommendation interventions after surgery. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BS-GLP group1. 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. | Combination product | BS-GLP group |
| BS group1. 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. | Procedure or surgery | BS group |
Primary outcome
the Percentage of weight loss
Time frame: 1 year
Through study completion, an average of 1 year, the investigators will observe the Percentage of weight loss.
22 secondary outcomes
Gender
Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Ethnicity
Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Height in meters
Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Weight in kilograms
Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Waist circumference in centimeters
Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Hip circumference in centimeters
Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Blood pressure
Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Serum creatinine
Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Glomerular filtration rate
Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Fasting blood glucose
Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Average blood glucose from continuous glucose monitoring
Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Postprandial 2-hour blood glucose
Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
HbA1c
Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Urinary microalbumin and other Urinalysis indexes
Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Total cholesterol
Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Low-Density Lipoprotein(LDL)
Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
High-Density Lipoprotein(HDL)
Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Triglycerides
Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Alanine Aminotransferase(ALT)
Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Aspartate Aminotransferase(AST)
Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
urine microalbumin-to-creatinine ratio (ACR)
Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
uric acid(UA)
Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hua Meng, Ph.D principal investigator
China-Japan Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BS-GLP group and BS group in people with Obesity, run by China-Japan Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yishan Huang, Ph.D (18810621201, bucmyishan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Percentage of weight loss (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.