ObesityNCT07633639
GLP-1 Therapy After Bariatric Surgery in Chinese Patients With Obesity
A study testing LSG-Semaglutide group, LSG-Mazdutide group and LSG-Tirzepatide 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 monotherapy. While bariatric surgery remains the most effective weight-loss intervention, postoperative weight regain and metabolic deterioration remain significant concerns. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity
- What is being tested?
- LSG-Semaglutide group, LSG-Mazdutide group and LSG-Tirzepatide 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 May 2026to 1 May 2028
- Phase
- Interventional
- 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
- 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.
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:
- 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).
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
Meng, +8618611457779, 1689024958@qq.com
About this study
Official title: The Efficacy and Safety of Adjuvant GLP-1 Receptor Agonist Therapy Following Metabolic Bariatric Surgery in Chinese Patients With Obesity: A Prospective, Monocentric, Stratified Randomized Controlled Trial
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.
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. Tirzepatide, as the first approved GLP-1/GIP dual-target agonist, demonstrates superior hypoglycemic and weight loss effects compared to Semaglutide through its synergistic interaction with GLP-1. Mazdutide, the first GLP-1/GCG dual-target agonist to enter phase III clinical trials in China, promotes fatty acid oxidation and energy consumption while acting synergistically with GLP-1's appetite-suppressing effect. It can effectively reduce liver fat content while achieving weight loss.
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. We will compare the long-term safety and effectiveness of different combination regimens for weight management and metabolic improvement in Chinese patients with obesity.
- Conditions
- Obesity
- Being tested
- LSG-Semaglutide group, LSG-Mazdutide group, LSG-Tirzepatide group, LSG group
- Keywords
- obesity, Glucagon-Like Peptide-1 Receptor Agonists, Metabolic Bariatric Surgery, Semaglutide, Mazdutide, Tirzepatide
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LSG-Semaglutide 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 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 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 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 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 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 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 |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Procedure: LSG group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of weight loss.
Measured: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Secondary outcomes (26)
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
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.
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.
body fat percentage(BFP)
Measured: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Visceral fat area
Measured: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Muscle mass in kilograms
Measured: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Body fat percentage
Measured: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
lean body mass (LBM)
Measured: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
lean body mass percentage (LBMP)
Measured: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Liver Stiffness Measurement(LSM)
Measured: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Controlled Attenuation Parameter(CAP)
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 posted8 Jun 2026
- Study start1 May 2026
- Primary completion1 May 2028 (estimated)
- Study completion1 May 2028 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07633639
- Sponsor's protocol ID
- 2026-CJH-OBE
- Status last verified
- May 2026
- First submitted
- 18 May 2026
- Last updated
- 8 Jun 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 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Adjuvant GLP-1 Receptor Agonist Therapy Following Metabolic Bariatric Surgery in Chinese Patients With Obesity: A Prospective, Monocentric, Stratified Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07633639
- Acronym / sponsor ID
- 2026-CJH-OBE
- Conditions
- Obesity
- Keywords
- obesity, Glucagon-Like Peptide-1 Receptor Agonists, Metabolic Bariatric Surgery, Semaglutide, Mazdutide, Tirzepatide
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 8 Jun 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 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.
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. Tirzepatide, as the first approved GLP-1/GIP dual-target agonist, demonstrates superior hypoglycemic and weight loss effects compared to Semaglutide through its synergistic interaction with GLP-1. Mazdutide, the first GLP-1/GCG dual-target agonist to enter phase III clinical trials in China, promotes fatty acid oxidation and energy consumption while acting synergistically with GLP-1's appetite-suppressing effect. It can effectively reduce liver fat content while achieving weight loss.
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. We will compare the long-term safety and effectiveness of different combination regimens for weight management and metabolic improvement in Chinese patients with obesity.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| LSG-Semaglutide group | Experimental | Combination Product: LSG-Semaglutide 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. |
| LSG-Mazdutide group | Experimental | Combination Product: LSG-Mazdutide groupNames 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. |
| LSG-Tirzepatide group | Experimental | Combination Product: LSG-Tirzepatide groupNames 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. |
| LSG group | Other | Procedure: LSG 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)
- 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.
Key exclusion criteria (6 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 |
|---|---|---|
| LSG-Semaglutide 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 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. | Combination product | LSG-Semaglutide group |
| LSG-Mazdutide 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 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. | Combination product | LSG-Mazdutide group |
| LSG-Tirzepatide 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 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. | Combination product | LSG-Tirzepatide group |
| LSG 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 | LSG group |
Primary outcome
Percentage of weight loss.
Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
26 secondary outcomes
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
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.
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.
body fat percentage(BFP)
Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Visceral fat area
Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Muscle mass in kilograms
Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Body fat percentage
Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
lean body mass (LBM)
Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
lean body mass percentage (LBMP)
Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Liver Stiffness Measurement(LSM)
Time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.
Controlled Attenuation Parameter(CAP)
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 8 Jun 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LSG-Semaglutide group, LSG-Mazdutide group and LSG-Tirzepatide 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 6 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 8 Jun 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.
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 (+8618612256920, yuanwen0920@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of weight loss. (time frame: Immediately postoperatively (Day 0), and at 1, 3, 6, and 12 months postoperatively.). 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 8 Jun 2026.