Overweight/obese
Conditions
Interventions
Sponsors
The Second Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age between 18 and 75 years, inclusive, of any gender; 2.Body mass index (BMI) >=28.0 kg/m^2 or 24.0 kg/m^2 <= BMI < 28.0 kg/m^2 accompanied by at least one of the following: (1). Prediabetes, hypertension, dyslipidemia, or fatty liver; (2). Weight-bearing joint pain; (3). Obesity-induced dyspnea or obstructive sleep apnea syndrome; 3.Stable body weight for 3 months prior to screening; 4.No fertility plans from screening to 6 months after study completion, willing to use contraceptive measures, and no sperm or egg donation plans within 6 months after study completion; 5.Fully informed about the study and voluntarily signed the written informed consent form.
Exclusion criteria
Exclusion criteria: 1.Known hypersensitivity to the investigational drug or its formulation excipients, or to other GLP-1 receptor agonist drugs, or a history of clinically significant multiple or severe drug allergies, or current allergic diseases, or high sensitivity constitution; 2.History of use of any of the following drugs or treatments within the specified periods prior to screening: (1) GLP-1 receptor agonists, GLP-1R/GCGR agonists, or GLP-1R/GIPR/GCGR agonists within 3 months before screening; (2) Over-the-counter weight-loss drugs or appetite suppressants within 3 months before screening, or prescription weight-loss drugs or lipolytic injectables within 3 months before screening; (3) Drugs likely to affect body weight (e.g.systemic glucocorticoids, tricyclic antidepressants, antipsychotics, or antiepileptics) for >=2 consecutive weeks within 3 months before screening or expected during the trial; (4) Antidiabetic drugs (e.g.metformin, SGLT2 inhibitors,thiazolidinediones) within 3 months before screening; 3.History or evidence of any of the following diseases: (1) Diagnosis of type 1 diabetes, type 2 diabetes, or other types of diabetes; (2) History of acute or chronic pancreatitis or pancreatic surgery; (3) Symptomatic gallbladder disease within 2 years before screening (defined as imaging evidence of gallstones with doctor-diagnosed abdominal pain attributable to gallstones); subjects who have undergone cholecystectomy and/or cholelithiasis treatment without long-term complications may participate; (4) Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2; (5) Secondary obesity due to disease or medication; (6) History of bariatric surgery (excluding: acupuncture for weight loss, liposuction, or abdominal liposuction performed >1 year before screening; gastric banding removed >1 year before screening; intragastric balloon removed >1 year before screening; duodenal-jejunal bypass sleeve removed >1 year before screening); (7) History of depression or Patient Health Questionnaire-9 (PHQ-9) score >=15 at screening; or history of severe mental illness (including suicidal ideation/attempts, schizophrenia, bipolar disorder, etc.); (8) Clinically significant cardiovascular disease within 6 months before screening (defined as: i. Myocardial infarction or unstable angina; ii. Cardiac surgery; iii. Congestive heart failure; iv. Cerebrovascular accident, including stroke/transient ischemic attack; v. Other cardiovascular diseases deemed unsuitable for the trial by the investigator); (9) History of retinal disease; (10) History of severe hypoglycemia or recurrent symptomatic hypoglycemia; (11) Concurrent gastroparesis or other gastrointestinal motility disorders, uncontrolled gastroesophageal reflux disease, or gastrointestinal diseases that increase the risk of adverse events with medication use; (12) Major surgery, severe trauma, or severe infection within 1 month before screening, as judged by the investigator to be unsuitable for the trial; (13) History of malignant tumors; (14) Limb deformities or disabilities that prevent accurate measurement of height, weight, or other indicators; (15) Concurrent diseases (e.g.neurological, endocrine, mental diseases) that, in the investigator’s opinion, may affect subject safety, efficacy evaluation, or compliance; 4.Screening abnormalities in any of the following tests: (1) HbA1c >=6.5% or fasting blood glucose (FBG) >=7.0 mmol/L; if FBG is 6.1–6.9 mmol/L at screening, an o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body Weight; | — |
Secondary
| Measure | Time frame |
|---|---|
| Waist Circumference;BMI;Fasting Serum Lipids;Blood pressure;HbA1c;Adverse Events;Mental Health Status;Plasma Concentration;Serum Anti-UBT251 Antibody Incidence;Titre and neutralizing antibody testing of antibody-positive samples;Electrocardiogram (ECG) Results;Vital Signs;Physical Examination;Laboratory Tests; | — |
Countries
China
Contacts
Public ContactZhou Zhiguang
The Second Xiangya Hospital Central of South University
Outcome results
None listed