Weight management in overweight or obese people
Conditions
Interventions
Low-dose test group:The provisional dose was 200 mg, 4 ABP2111Na tablets (25 mg/tablet, 75 mg/tablet, 2 tablets each) and 2 ABP2111Na tablets placebo (25 mg/tablet placebo, 75 mg/tablet placebo, 1 tab
High-dose test group:The provisional dose was 300 mg of 6 ABP2111Na tablets (25 mg/tablet, 75 mg/tablet, 3 tablets each) taken orally on an empty stomach/after a meal once daily in the morning for 26
Placebo group:Six ABP2111Na tablets placebo (25 mg/tablet placebo, 75 mg/tablet placebo, 3 tablets each) were administered orally on an empty stomach/after a meal once daily in the morning for 26 week
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Only those who meet all the following conditions can be enrolled: 1. Age 18~60 years old (including 18 and 60 years old), gender is not limited; 2. Body mass index (BMI) >=28 kg/m^2 with or without concomitant comorbidities, or BMI >=24 kg/m^2 and <28 kg/m^2 with comorbid weight-related complications: a. High appetite, insatiable pre-meal hunger, and eating more at each meal; b. Comorbidity with pre-diabetes (impaired fasting glucose), hypertension, dyslipidemia, or fatty liver (within the last 6 months prior to screening); c. Comorbidity with weight-bearing joint pain; d. Obesity-induced dyspnea or presence of obstructive sleep apnea syndrome; 3. Those with stable weight (weight change <5%, weight change = [maximal weight - minimal weight]/maximal weight; based on participant self-report) in the 12 weeks prior to screening; 4. Able to understand the procedures and methods of this study, willing to complete the study in strict compliance with the clinical study protocol, and voluntarily signing the informed consent form.
Exclusion criteria
Exclusion criteria: Those who meet one of the following criteria are not eligible for enrollment: 1. Those with a combination of moderate-to-severe dry mouth, sore throat, oral ulcers, or oral herpes at screening or baseline; 2. Pre-existing diagnosis of obesity due to endocrine disease or single gene mutation, including, but not limited to, hypothalamic obesity, pituitary obesity, hypothyroid obesity, Cushing's syndrome, pancreatic islet cell tumors, acromegaly; 3. Known hypersensitivity or allergy to this product or any of the excipient ingredients in this product; 4. A prior diagnosis of type 1 diabetes, type 2 diabetes, or other specific type of diabetes; 5. The presence or prior presence of hematological disorders, neoplasms, renal disorders, endocrine disorders, pulmonary disorders, gastrointestinal disorders, hepatic disorders, and neurological disorders that may affect participant safety or determination of study results; 6. Comorbid hepatic disease or prior history of hepatic disease at the time of screening, including, but not limited to: cirrhosis, primary biliary cholangitis, primary sclerosing cholangitis, alcoholic liver disease, definite autoimmune liver disease, drug-induced hepatic injury, known bile duct obstruction, suspected or confirmed hepatocellular carcinoma, or evidence of decompensated hepatic disease (i.e., ascites, bleeding from fundal esophagogastric varices, or hepatic encephalopathy); 7. At the time of screening, those who meet any of the following criteria related to cardiovascular function: - a history of myocardial infarction, coronary angioplasty or bypass grafting, cardiac valvular disease or cardiac valve repair, clinically significant unstable arrhythmia, unstable angina pectoris, transient ischemic attack, or cerebral vascular accident within the 6 months prior to screening; - a history of a New York Heart Association ( Congestive heart failure of NYHA class III or IV within 6 months prior to screening; - Combined serious arrhythmia requiring treatment (e.g., long QT interval syndrome) within 6 months prior to screening that is assessed by the investigator to be unsuitable for participation in this study; - Uncontrolled hypertension (i.e., systolic blood pressure =160 mm Hg or diastolic blood pressure =100 mm Hg) within 6 months prior to screening; - Electrocardiograms at the time of screening indicating the presence of a cardiovascular disease that may affect the safety of the participant or the interpretation of study results. Clinically relevant abnormalities on the ECG at screening that may affect participant safety or interpretation of the study results (e.g., QTcF >=450 ms in men, QTcF >=470 ms in women, complete left bundle branch block, signs of acute or acute-slow unspecified myocardial infarction, ST-segment changes suggestive of myocardial ischemia, second- or third-degree atrioventricular block, or severe bradyarrhythmias or tachyarrhythmias); - Resting heart rate >100 beats per minute; - other abnormalities of cardiac function that are judged abnormal and clinically significant by the investigator; 8. A malignant tumor (except basal cell carcinoma or carcinoma in situ that has been clinically cured) within 5 years prior to screening; 9. Medullary thyroid carcinoma or multiple endocrine adenoma syndrome type 2, or a family history of such disease 10. Persons with a previous history of pancreatitis or symptomatic gallbladder disease; 11. A prior history of proliferative retinopathy and macu
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effectiveness indicators ((percentage change in weight from baseline, proportion of participants with >=5% weight loss from baseline)); | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety indicators (adverse events, vital signs, physical examination, laboratory tests, ECG, ultrasound, etc.); | — |
Countries
China
Contacts
Public ContactLinong Ji
Peking University People's Hospital
Outcome results
None listed