Severe obesity
Conditions
Interventions
Sleeve gastrectomy combined with Mazdutide as adjuvant therapy:Sleeve gastrectomy combined with Mazdutide as adjuvant therapy group
Sleeve gastrectomy combined with Mazdutide Placebo as adjuvant therapy:Sleeve gastrectomy combined with Mazdutide Placebo as adjuvant therapy group
Sponsors
Beijing Friendship Hospital ,Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Age 18–70, no gender restrictions; 2.BMI >= 37.5 kg/m^2 with or without obesity-related diseases; 3.scheduled for sleeve gastrectomy; 4.Fully understand and sign the informed consent form for the study;
Exclusion criteria
Exclusion criteria: 1.Individuals who have undergone gastrointestinal surgery, such as gastrectomy or duodenal surgery, or weight loss and metabolic surgery in the past. 2.Individuals with a personal or family history of medullary thyroid carcinoma, or those with multiple endocrine neoplasia type 2; 3.ALT > 3×ULN (if diagnosed with MAFLD during the screening period or within 6 months prior to screening, ALT 3×ULN, or total bilirubin > 2×ULN; 4.Estimated glomerular filtration rate (eGFR) 100 beats per minute), or suggests second-degree or third-degree atrioventricular block, long QT syndrome, or QTcf >450 ms (males), QTcf >470 ms (females), left or right bundle branch block, Wolff-Parkinson-White syndrome, or other significant arrhythmias (excluding sinus arrhythmia); 7.A history of acute hyperglycemia/hypoglycemia events within the past year, including diabetic ketoacidosis, hyperglycemic hyperosmolar state, hypoglycemic coma, etc. 8.History of severe cardiovascular and cerebrovascular diseases (such as myocardial infarction, stroke, etc.); 9.Individuals with a history of mental or psychological disorders at baseline or during screening/randomization (e.g., history of moderate-to-severe depression or PHQ score >= 15; Suicidal tendencies, suicidal behavior, or a Columbia Suicide Severity Rating Scale (C-SSRS) score of Category 4 or 5, or selecting "Yes" for suicidal behavior or suicidal ideation; Schizophrenia, bipolar disorder, etc. 10.Individuals with a history of specific infectious diseases (such as acquired immunodeficiency syndrome, syphilis, hepatitis B, hepatitis C, etc.); 11.Individuals with terminal illnesses with a life expectancy of less than 5 years or those with a history of or current malignant tumors; 12.Patients who have used GLP-1 receptor agonists, dual GLP-1/glucose-dependent insulinotropic polypeptide (GIP) receptor agonists, or dual GLP-1/glucagon-like peptide-1 receptor agonists within the past 3 months. 13.History of excessive alcohol consumption (see Appendix 11) and drug abuse during screening; 14.History of special medication use (>2 doses per week), such as moderate anticholinergic drugs, antiparkinsonian drugs, antiepileptic drugs, antipsychotic drugs, benzodiazepines and sedatives, morphine and narcotic analgesics, stimulant drugs, medical cannabis, cannabis, and cannabidiol (CBD). 15.Individuals who are breastfeeding, pregnant, or planning to conceive during the study period; 16.Clinical investigators who have participated in other clinical studies with conflicts of interest related to this research; 17.Individuals with known allergies to the active ingredient of the investigational drug or any of its excipients;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| At 48 weeks post-surgery, the percentage reduction in excess weight compared to baseline was 48% at 48 weeks post-surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in ALT and AST at 48 weeks compared to baseline;Assess changes in body fat percentage and muscle mass at 48 weeks;Change in blood pressure at 48 weeks compared to baseline;Percentage change in hip circumference at 48 weeks compared to baseline;Change in serum uric acid levels at 48 weeks compared to baseline;Proportion of patients experiencing weight regain at 96 weeks;Incidence of surgery- and medication-related complications at 48 weeks, readmission rate, and incidence of major adverse cardiovascular events;Percentage change in waist circumference at 48 weeks compared to baseline;Percentage reduction in total body weight at 48 weeks compared to baseline(TBWL%);Changes in weight-related quality of life (IWQOL-Lite), upper gastrointestinal disease questionnaire (GERDQ), and overall quality of life (SF-36) at 48 weeks;Evaluate improvements in BMI classification at 48 weeks compared to baseline;Changes in triglycerides, high-density lipoprotein cholesterol, total cholesterol, and low-density lipoprotein cholesterol at 48 weeks compared to baseline;Changes in nutritional levels (hemoglobin, albumin, vitamins, folate, serum iron, etc.) at 48 weeks post-surgery compared to baseline;Assess changes in liver fat content and pancreatic fat content at 48 weeks; | — |
Countries
China
Contacts
Public ContactZhang Zhongtao
Beijing Friendship Hospital ,Capital Medical University
Outcome results
None listed