Weight management in overweight or obese people
Conditions
Interventions
Experimental group:ABP2111Na tablets were administered for 28 consecutive days and sequentially entered into 3 dose groups of 50 mg, 100 mg, and 200 mg of ABP2111Na tablets (75 mg, 150 mg TBD, dose ma
Placebo group:ABP2111Na tablets placebo was administered for 28 consecutive days and sequentially entered into 3 dose groups of ABP2111Na tablets 50 mg, 100 mg and 200 mg.
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 of the following conditions can be enrolled: (1) Age 18-60 years (inclusive of 18 and 60 years) and gender; (2) Body mass index (BMI) =28 kg/m2 with or without concomitant comorbidities, or BMI =24 kg/m2 and <28 kg/m2 with concomitant weight-related complications such as dyslipidaemia; (3) Stable weight (weight change <5%, weight change = [maximal weight - minimal weight]/maximal weight; based on subject 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 enrolment: (1) 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 tumour, acromegaly; (2) Known hypersensitivity or allergy to the product or any of the excipient ingredients in the product; (3) Persons with a pre-existing diagnosis of type 1 diabetes mellitus, type 2 diabetes mellitus, or other specific types of diabetes mellitus; (4) Presence or previous presence of haematological disorders, neoplasms, renal disorders, endocrine disorders, pulmonary disorders, gastrointestinal disorders, cardiovascular disorders, hepatic disorders, psychiatric disorders, neurological disorders, which may affect the safety of the subject or the determination of the results of the study; (5) Volunteers with medullary thyroid cancer or multiple endocrine adenoma syndrome type 2 disease, or a family history of such disease; (6) Persons with a prior history of pancreatitis or symptomatic gallbladder disease; (7) Persons with a prior history of proliferative retinopathy and macular disease; (8) A history of or current mental illness, the presence of a moderately severe or major depressive state, or a perceived significant risk of suicide; (9) Laboratory test items that meet any of the following criteria: haemoglobin (Hb) 1.5 × ULN; triglycerides >5.6 mmol/L, low-density lipoprotein cholesterol (LDL-C) =4.40 mmol/L; and an eGFR 6 mIU/L or <0.4 mIU/ L; glycated haemoglobin (HbA1c) =6.5%; fasting plasma glucose (FPG) =7.0 mmol/L; (10) Those who have difficulty swallowing, or have a condition that interferes with gastrointestinal absorption (e.g., inflammatory bowel disease, active ulcers), or have undergone gastrointestinal surgery that can lead to malabsorption, or have received long-term medications/treatments that have an effect on gastrointestinal motility [e.g., those who have undergone bariatric surgery or manipulation (e.g., gastric banding); (11) Persons with a history of hypoglycaemia prior to screening; (12) Use of any of the following medications or treatments within 12 weeks prior to screening: 1) oral or injectable hypoglycemic medications such as dipeptidyl peptidase-4 (DPP-4) inhibitors, sodium-glucose co-transporter protein-2 (SGLT-2) inhibitors, metformin, insulinotropic agents, thiazolidinediones (TZDs), and insulin, and 2) any approved or unapproved weight-loss medications (e.g., Orlistat tat, lorcaserin, phentermine/topiramate, naltrexone/bupropion, simethicone, exenatide, liraglutide, beraplatide, losenatide, tilpeptide, etc.) or weight-affecting herbal medications, health supplements, and meal replacements; and 3) use of medications that may have resulted in a significant change in body weight, including systemic (i.e., administered intravenously, orally or intra-articularly) glucocorticosteroids that lasted for more than 1 week; tricyclic antidepressants; antipsychotic or antiepileptic drugs (e.g., mipramine, amitripty
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic (PK) profile;Pharmacodynamic (PD) profile;Changes in weight, waist circumference, hip circumference, BMI, and waist-to-hip ratio.;Cardiac safety (concentration-QTc intervals); | — |
Countries
China
Contacts
Public ContactLinong JI
Peking University People's Hospital
Outcome results
None listed