Obesity or Overweight
Conditions
Interventions
Test group:44 weeks of treatment with Hui Sheng semaglutide starting from 0.25 mg once weekly for 4 weeks, increasing to 0.5 mg oncely weeks for 4 weeks and then 1.7 mg once weeks for 4 weeks, reachin
Control group:44 weeks of treatment with originator semaglutide (WEGOVY), starting from 0.25 mg once weekly for 4 weeks, increasing to 0.5 mg oncely weeks for 4 weeks and then 1.7 mg once weeks for 4
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign the informed consent; 2. Males and females who signed the informed consent are 18 to 75 years old (both inclusive); 3. One or more self-reported history of unsuccessful weight loss; 4. Stable weight within the first 3 months before screening (absolute value of weight change reported by the participant less than 5kg) ; 5. At screening/randomization, body mass index (BMI) 28kg/m^2; 6. Participants who are willing and able to follow dietary, exercise, treatment and follow-up visits as required in the protocol.
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria are not eligible for this study: 1. Diagnosed with type 1 diabetes mellitus, type 2 diabetes mellitus, or specific types of diabetes; 2. Subjects have received any of the following drugs or treatments below: (1) Use of glucagon-like peptide-1 (GLP-1) receptor agonists, drugs with GLP-1 receptor agonist mechanisms, or GLP-1 RA containing combination preparations within 6 months before screening/randomization; (2) Have received any prescription or over-the-counter weight-loss drugs, appetite suppressants, lipolytic injections, meal replacements, and acupoint treatments for weight loss within 3 months before screening; (3) Have received drugs that may cause significant weight changes within 3 months before screening or during the expected trial treatment period; (4) Prior or planned obesity treatment with surgery or weight loss devices during the trial, except for the following situations: Fat aspiration and/or abdominal wall shaping surgery, and performed>1 year before screening; Adjustable gastric banding procedure, with the band removed>1 year prior to screening; Gastric balloon, and the balloon has been removed more than 1 year before screening; Duodenal jejunal bypass tube surgery, and the tube sleeve has been removed more than 1 year before screening 3. Subjects with any of the following histories or conditions below: (1) With untreated or inadequately controlled hypertension (defined as systolic blood pressure >=160 mmhg and/or diastolic blood pressure >=100 mmhg) at screening/randomization; (2) With cardiovascular diseases such as acute coronary syndrome (including but not limited to acute myocardial infarction, or unstable angina pectoris), severe arrhythmia, severe heart failure (NYHA functional classification III or IV), history of coronary artery bypass grafting or coronary stent implantation within 6 months before screening; (3) With new cerebrovascular accident (including ischemic stroke, hemorrhagic stroke and transient ischemic attack) within 6 months before screening; (4) With severe trauma or severe infection requiring intravenous antimicrobial or anti-pathogen therapy within 1 month before screening/randomization; (5) With a history of acute or chronic pancreatitis before screening/randomization; (6) With cholelithiasis or cholecystitis newly diagnosed or symptomatic or requiring treatment within 6 months before screening / randomization; (7) Obesity caused by other endocrine diseases, including hypothalamic obesity, pituitary obesity, hypothyroid obesity, Cushing's syndrome, insulinoma, acromegaly, pseudohypoparathyroidism, hypogonadism, polycystic ovary syndrome; (8) With significant abnormalities of gastric emptying and serious gastrointestinal diseases during screening/randomization; (9) With medullary thyroid cancer (MTC) or multiple endocrine neoplasia type 2 (men2) disease history or family history during screening/randomization; (10) With concomitant thyroid disease or abnormal thyroid function test results that were clinically significant and required treatment, or were considered by the investigator to be at potential risk for disease progression although they did not require treatment; (11) With a history of malignant tumor in the past 5 years or currently evaluating potential malignant tumors, excluding clinically cured cervical carcinoma in situ and skin basal cell carcinoma; (12) Known to be hospitalized for surgical treatment; (13) With major depression, anxie
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage change in body weight from baseline to week 44; | — |
Secondary
| Measure | Time frame |
|---|---|
| The percentage of patients achieving greater than or equal to 5% weight loss from baseline to week 44;The change from baseline in waist circumference to week 44;Vital signs;Physical examination;Laboratory test (routine blood parameters);Laboratory test (urine routines);Laboratory test (blood biochemical parameters);12-lead electrocardiogram test;Adverse events; | — |
Countries
China
Contacts
Public ContactLinong Ji
Peking University People's Hospital
Outcome results
None listed