Obesity
Conditions
Interventions
Experimental Group:Dose adjustment treatment with Wegovy?for 16 weeks, starting with 0.25 mg once a week and increasing doses (0.5 mg, 1.0 mg, and 1.7 mg) every 4 weeks, is expected to last for 16 wee
Control Group:Dose adjustment treatment with semaglutide injection for 16 weeks, starting with 0.25 mg once a week and increasing doses (0.5 mg, 1.0 mg and 1.7 mg) every 4 weeks, is expected to last f
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Voluntarily participate in this trial and sign the informed consent form. 2.Male or female, aged 18-75 years (inclusive) at the time of signing the informed consent form. 3.Body mass index (BMI) >= 28.0 kg/m^2 at screening. 4.At least one self-reported unsuccessful weight loss history.
Exclusion criteria
Exclusion criteria: Blood sugar-related: 1. Glycosylated hemoglobin (HbA1c) level >=6.5% at screening. 2. History of type 1 or type 2 diabetes mellitus. 3. Within 90 days before screening, have received hypoglycemic drug treatment. 4. Received GLP-1 receptor agonist therapy within 180 days prior to screening. Obesity-related: 5. Self-reported weight change of >5kg within 90 days prior to screening, regardless of whether there is a medical record recorded. 6. Received any medication for obesity within 90 days prior to screening. 7. Prior or planned treatment of obesity by surgical or bariatric instrumentation during the trial period, with the following exceptions: (1) liposuction and/or abdominal liposuction performed > 1 year prior to screening; (2) Gastric banding that has been removed before screening for 1 year >; (3) Intragastric balloon placement > 1 year before screening balloon removal. Mental Health Related: 8. Previous history of major depressive disorder, or Patient Health Status Questionnaire-9 (PHQ-9) >=15 at screening. 9. Diagnosed with other severe mental illnesses, including: schizophrenia, schizoaffective disorder, paranoid psychosis, bipolar (affective) disorder, mental disorder caused by epilepsy, mental retardation with mental disorder. 10. Have ever committed suicide. 11. Suicidal thoughts corresponding to type 4 or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening. General Safety: 12. Thyroid disease: including personal or family history of medullary thyroid carcinoma (MTC) or type 2 multiple endocrine tumor syndrome (MEN2); or calcitonin (CT) >=50ng/L at screening; or thyroid-stimulating hormone (TSH) > 6.0 mIU/L or =3×ULN at screening, or triglycerides (TG) >=5.65mmol/(500mg/dL) at screening. 14. Alanine aminotransferase (ALT) >=3×ULN, aspartate aminotransferase (AST) >=3×ULN, total bilirubin (TBiL) > at screening=3×ULN. 15. Blood creatinine level at screening > = 1.5 mg/dL (132 µmol/L) for males or > = 1.4 mg/dL (123 µmol/L) for females. 16. Untreated or poorly controlled hypertension (defined as systolic blood pressure =160mmHg and/or diastolic blood pressure >=100mmHg). 17. History of severe cardiac disease, defined as New York Heart Association (NYHA) grade III and IV. at screening, and/or hospitalization for unstable angina, transient ischemic attack within 60 days prior to screening, and/or stroke (except lacunar cerebral infarction), myocardial infarction within 180 days prior to screening. 18. Gastrointestinal diseases that may increase the risk after medication as assessed by the investigator (such as obstructive diseases: pyloric obstruction and intestinal obstruction; or gastrointestinal motility disorders: postoperative gastric paralysis, idiopathic gastric paralysis; or severe active ulcers, etc.). 19. Known or suspected allergy to any component of semaglutide injection or allergy to other GLP-1 receptor agonist drugs. 20. Use of drugs that may cause significant weight gain within 90 days prior to screening or in the expected trial, including systemic glucocorticoid therapy for more than 1 week; tricyclic antidepressants (e.g., amitriptyline, mipramine, clomipramine, doxepin); Antipsychotic or epileptic drugs (eg, mirtazapine, paroxetine, phenelzine, chlorpromazine hydrochloride, clozapine, olanzapine, valeric acid and its derivatives, lithium preparations, methiodiazine). 21. Obes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight; | — |
Secondary
| Measure | Time frame |
|---|---|
| Weight;Subjects who achieve body weight reduction equal to or above 5%;Subjects who achieve body weight reduction equal to or above 10%;Subjects who achieve body weight reduction equal to or above 15%;Body Mass Index (BMI);Waist Circumference;Systolic blood pressure and diastolic blood pressure;From baseline at week 0 to week 44;Mental Health Status Assessment;Laboratory Examination;Electrocardiogram;Vital Signs; | — |
Countries
China
Contacts
Public ContactXiaoying Li
Zhongshan Hospital, Fudan University
Outcome results
None listed