SMART

Not yet recruitingPhase NA

Mazdutide as Adjuvant Therapy Following Sleeve Gastrectomy in Severe Obesity

Mazdutide as Adjuvant Therapy Following Sleeve Gastrectomy in Severe Obesity:A Multicenter, Randomized, Double-Blind, Placebo-Controlled Superiority Trial

Lead sponsor

Beijing Friendship Hospital

Asset

Mazdutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

Recruiting sites

—

Enrollment

256

estimated

Study population

Bariatric Surgery, Obesity / overweight

Key I/E criterion

•BMI ≥37.5

Primary endpoint

•Excess weight loss(EWL%) compared

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07135141

Org study IDSMART trial

Timeline

Milestones

Study first posted2025-08-21actual

Last update posted2025-08-21actual

Study start2025-09-30estimated

Primary completion2027-09-30estimated

Study completion2029-09-30estimated

Assets

Investigational agents

Mazdutide

Study populations

Who this study enrolls

Bariatric SurgeryObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age70 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Aged 18-70 years (inclusive), male or female;

•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

•Previous gastrointestinal surgery such as stomach and duodenum, or weight loss and metabolic surgery;

•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;

Endpoints (15)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition

MASH / liver

Cardiometabolic biomarkers

Other (unclassified)

Patient-reported / QoL

Safety / tolerability / PK

Weight & body composition

7 endpoints

Primary/protocol endpoint

the rate of excess weight loss(EWL%) compared to baseline

Time frame:At 48th week post procedure

percent change from baseline, improvement

Secondary/protocol endpoint

Assessing the change in BMI(kilogram/square meter, kg/m²） classification compared to baseline(Based on the BMI classification in Chinese adiposity diagnosis and treatment guideline 2024)

Time frame:At 48th week post procedure

categorical status, improvement

Secondary/protocol endpoint

Assessing the rate of total body weight loss(TBWL%) compared to baseline

Time frame:At 48th week post procedure

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Assessing the change of waist circumference(centimeter, cm) compared to baseline

Time frame:at 48th week post procedure

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Assessing the change of hip circumference(centimeter, cm) compared to baseline

Time frame:At 48th week post procedure

change from baseline, improvement

Secondary/protocol endpoint

Assessing the percentage change（%） of body fat or fat-free mass compared to baseline

Time frame:At 48th week post procedure

Total fat mass

percent change from baseline, improvement

Secondary/protocol endpoint

Assessing the rate(%) of body weight regain among participants

Time frame:At 96th week post procedure

threshold achievement, improvement

MASH / liver

2 endpoints

Secondary/protocol endpoint/low confidence

Assessing the percentage change（%） of liver fat content or pancreatic fat content compared to baseline

Time frame:At 48th week post procedure

Liver fat content, change

percent change from baseline, improvement

componentsLiver fat content, change

Secondary/protocol endpoint

Assessing the change of aspartate transaminase(AST) or alanine aminotransferase(ALT) compared to baseline

Time frame:At 48th week post procedure

AST, change

change from baseline, improvement

LOINC 1920-8

Cardiometabolic biomarkers

2 endpoints

Secondary/protocol endpoint

Assessing the change of blood pressure(incl. systolic blood pressure and diastolic blood pressure) compared to baseline（Hydrargyrum, mmHg）

Time frame:At 48th week post procedure

change from baseline, improvement

componentsSystolic BP, change, Diastolic BP, change

Secondary/protocol endpoint

Assessing the percentage change(%) of triglyceride(TG), low-density lipoprotein cholesterol(LDL-C),total cholesterol(TC) or high-density lipoprotein cholesterol(HDL-C) compared to baseline

Time frame:At 48th week post procedure

Triglycerides, change

percent change from baseline, improvement

LOINC 2571-8

Patient-reported / QoL

1 endpoint

Secondary/protocol endpoint

Assessing the change of body weight related life quality(IWQOL-Lite) , upper GI symptom scale(GERDQ) or overall life quality scale(SF-36) compared to baseline

Time frame:At 48th week post procedure

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint/low confidence

Assessing the rate(%) of procedure-related or drug-related complications, re-admission, or major cardiovascular adverse events

Time frame:At 48th week post procedure

composite event, event

componentsNausea, Vomiting, Diarrhea, Expanded / custom MACE composite, All-cause hospitalization

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Assessing the change(%) of serum uric acid compared to baseline

Time frame:At 48th week post procedure

percent change from baseline, improvement

Secondary/protocol endpoint/low confidence

Assessing the change of nutrition status (incl. albumin, victamin B12, folic acid or serum iron and so forth) compared to baseline

Time frame:At 48th week post procedure

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.