Mazdutide as Adjuvant Therapy Following Sleeve Gastrectomy in Severe Obesity
NCT ID: NCT07135141
Last Updated: 2025-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
256 participants
INTERVENTIONAL
2025-09-30
2029-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Sleeve gastrectomy plus mazdutide group
Participants will receive weekly subcutaneous injections of mazdutide at 5th month post sleeve gastrectomy(starting at 2.0 mg, with stepwise dose escalation to a target maintenance dose of 6.0 mg and optional adaptive downgrade to 4.0 mg if necessary)
Sleeve gastrectomy plus early mazdutide initiation
After sleeve gastrectomy is preformed, mazdutide injection (pre-filled auto-injector pen) is administered subcutaneously at the same time each week at 5th month post procedure. The treatment begins with a starting dose of 2.0 mg, followed by a titration schedule increasing by 2.0 mg every 4 weeks (2.0 mg → 4.0 mg). If well-tolerated, participants reached the target maintenance dose of 6.0 mg (4.0 mg → 6.0 mg)weekly for maintenance. The protocol permits adaptive dose downgrade to 4.0 mg weekly when clinically indicated, such as intolerance. The total intervention is maintained until 48 weeks post procedure.
Sleeve gastrectomy plus mazdutide placebo group
Participants will receive weekly subcutaneous injections of matched placebo at 5th month post sleeve gastrectomy
Sleeve gastrectomy followed with early mazdutide placebo initation
After sleeve gastrectomy is preformed, mazdutide placebo injection (pre-filled auto-injector pen) is administered subcutaneously at the same time each week at 5th month post procedure. The treatment begins with a starting dose of 2.0 mg placebo, followed by a titration schedule increasing by 2.0 mg every 4 weeks (2.0 mg → 4.0 mg). If well-tolerated, participants reached the target maintenance dose of 6.0 mg placebo(4.0 mg → 6.0 mg) weekly for maintenance. The protocol permits adaptive dose downgrade to 4.0 mg weekly when clinically indicated, such as intolerance. The total intervention is maintained until 48 weeks post procedure.
Interventions
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Sleeve gastrectomy plus early mazdutide initiation
After sleeve gastrectomy is preformed, mazdutide injection (pre-filled auto-injector pen) is administered subcutaneously at the same time each week at 5th month post procedure. The treatment begins with a starting dose of 2.0 mg, followed by a titration schedule increasing by 2.0 mg every 4 weeks (2.0 mg → 4.0 mg). If well-tolerated, participants reached the target maintenance dose of 6.0 mg (4.0 mg → 6.0 mg)weekly for maintenance. The protocol permits adaptive dose downgrade to 4.0 mg weekly when clinically indicated, such as intolerance. The total intervention is maintained until 48 weeks post procedure.
Sleeve gastrectomy followed with early mazdutide placebo initation
After sleeve gastrectomy is preformed, mazdutide placebo injection (pre-filled auto-injector pen) is administered subcutaneously at the same time each week at 5th month post procedure. The treatment begins with a starting dose of 2.0 mg placebo, followed by a titration schedule increasing by 2.0 mg every 4 weeks (2.0 mg → 4.0 mg). If well-tolerated, participants reached the target maintenance dose of 6.0 mg placebo(4.0 mg → 6.0 mg) weekly for maintenance. The protocol permits adaptive dose downgrade to 4.0 mg weekly when clinically indicated, such as intolerance. The total intervention is maintained until 48 weeks post procedure.
Eligibility Criteria
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Inclusion Criteria
* BMI≥37.5 kg/m2, with or without obesity-related complications;
* Planned to take sleeve gastrectomy
* Understand the trial protocol, voluntarily sign the informed consent form (ICF), and agree to follow all study requirements and restrictions.
Exclusion Criteria
* History of thyroid C-cell carcinoma, multiple endocrine neoplasia (MEN) 2A or 2B, or relevant family history;
* ALT \> 3.0 × ULN (if NAFLD is diagnosed at screening and within 6 months prior to screening, ALT ≤ 5.0 × ULN can be enrolled), or AST \> 3.0 ×ULN, or total bilirubin (TBIL) \> 2 × ULN
* Estimated glomerular filtration rate eGFR \< 45 mL/min/1.73 m2 using the CKD-EPI equation
* Chronic anemia：Hemoglobin \< 110 g/L (males) or \< 100 g/L (females)；
* Have the following 12-lead electrocardiogram (ECGs) abnormalities at screening(\<50 beats/min or \>100 beats/min), 2nd or 3rd degree atrioventricular block, long QT syndrome or QTcF \> 450 ms (males), QTcF \> 470 ms (females), left or right bundle branch block, pre-excitation syndrome, or other significant arrhythmia (except sinus arrhythmia);
* Acute hyperglycemic/hypoglycemic events within 1 year, including:
diabetic ketoacidosis (DKA), hyperosmolar hyperglycemic state (HHS), and hypoglycemic coma, etc;
* Participants with previous severe myocardial infarction, stroke, acute and chronic heart failure, cardiac procedure such as percutaneous coronary intervention, coronary artery bypass grafting, or are not suitable for participation in this study after the investigator's assessment;
* Previous or confirmed mental illness at screening/randomization phase\[Previous moderate to severe depressionPHQ questionnaire (Depression Screening Scale) ≥ 15 points, C-SSRS questionnaire (Columbia Suicide Severity Scale) category 4 or 5 at screening or randomization, or "Yes" in suicidal behavior or suicidal ideation\];
* Previous specific infectious diseases, incl. acquired immunodeficiency syndrome, viral hepatitis B, viral hepatitis C, etc;
* End-stage disease with an expected survival of less than 5 years or previous/current malignancy;
* Use of GLP-1 receptor (GLP-1R) agonists or GLP-1R/GCGR agonists or GIPR/GLP-1R agonists or GIPR/GLP-1R/GCGR agonists within three months prior to screening;
* History of alcohol or drug abuse at screening;
* History of specific drugs use beyond 2 times, incl. moderate anticholinergics, antiparkinsonians, antiepileptic drugs, antipsychotics, benzodiazepines and sedatives, morphine and narcotic analgesics, stimulant drugs, medical marijuana, marijuana, and cannabidiol, etc.;
* Pregnant or lactating females, males or females of childbearing potential who are not willing to use contraception throughout the study and for 8 weeks after the end of the study;
* Having participated in other clinical investigators who have a conflict of interest with this study;
* The investigator suspects that the participant may be allergic to ingredients in the study drug or drugs of the same class;
18 Years
70 Years
ALL
No
Sponsors
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Beijing Friendship Hospital
OTHER
Responsible Party
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Zhongtao Zhang
Professor, Vice president of hospital
Locations
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Beijing Friendship Hospital, Capital Medical University
Beijing, , China
Beijing Hospital
Beijing, , China
Peking University People's Unviersity
Beijing, , China
The Third Hospital of Central South University
Changsha, , China
West China Hospital of Sichuan University
Chengdu, , China
The First Affiliated Hospital of Jinan University(Guangzhou Overseas Chinese Hospital)
Guangzhou, , China
Qilu Hospital of Shandong University
Jinan, , China
Kunming First People's Hospital
Kunming, , China
Nanjing Drum Tower Hospital
Nanjing, , China
Huadong Hospital affiliated to Fudan University
Shanghai, , China
Shanghai Sixth People's Hospital to Shanghai Jiao Tong University School of Medicine
Shanghai, , China
The Second Hospital of Hebei Medical University
Shijiazhuang, , China
Tianjin Medical University General Hospital
Tianjing, , China
Zhongnan Hospital of Wuhan University
Wuhan, , China
Countries
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Central Contacts
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Facility Contacts
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Yi Chen
Role: primary
Other Identifiers
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SMART trial
Identifier Type: -
Identifier Source: org_study_id
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