Non-diabetic overweight or obese
Conditions
Interventions
Dose Group 1:ZX2021 Injection
Dose Group 2:ZX2021 Injection
Dose Group 3:ZX2021 Injection
Sponsors
Yunnan Provincial Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Participants must be Chinese, non-diabetic, overweight or obese, male or female, aged 18 to 50 years (inclusive) at screening, with the date of signing the informed consent form as the reference. 2. For obese participants: BMI >= 28.0 kg/m^2; for overweight participants: 24.0 <= BMI < 28.0 kg/m^2, and with at least one of the following conditions: (1) combined with prediabetes (impaired fasting glucose and/or impaired glucose tolerance), grade 1 hypertension, non-alcoholic fatty liver disease, or dyslipidemia (one or more); (2) combined with pain in weight-bearing joints; (3) combined with obesity-induced dyspnea or obstructive sleep apnea syndrome. 3. Body weight change within 12 weeks prior to screening < 5.0% (by subject's self-report). The percentage of weight change is calculated as:(maximum weight [kg] - minimum weight [kg] within the 12 weeks prior to screening) / minimum weight [kg] within the 12 weeks prior to screening × 100%; 4. Female participants must have no plan to become pregnant or donate ova from 14 days prior to the first dose until 4 months after the last dose, and voluntarily agree to use effective contraceptive measures to avoid pregnancy. Male participants must have no plan to father a child or donate sperm from the first dose until 4 months after the last dose, and voluntarily agree to use effective contraceptive measures to avoid causing pregnancy in their partners. 5. Participants must be able to communicate effectively with the investigator, fully understand the study content, procedures, and potential adverse reactions, voluntarily participate, be capable of completing the study as per the protocol, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Have a history of severe drug allergy (especially known or suspected allergy to any ingredient or excipient of ZX2021 Injection), or have severe atopic diseases/history, or severe allergic constitution. 2. Have a history or evidence of any of the following diseases: (1) Obesity secondary to other diseases or medications, including elevated cortisol levels (e.g., Cushing's syndrome), obesity due to pituitary or hypothalamic injury, or obesity due to reduction or discontinuation of weight-loss medications. (2) Previously diagnosed with type 1 or type 2 diabetes mellitus. (3) Previously diagnosed with acute or chronic pancreatitis, or pancreatic injury. (4) Previously diagnosed with medullary thyroid carcinoma, multiple endocrine neoplasia (MEN) type 2A or 2B, or have a related family history. (5) Previously underwent bariatric surgery, or had liposuction or fat-removal surgery within 1 year prior to screening, or plan to undergo any surgery that significantly affects body weight (such as bariatric surgery, liposuction, or abdominal fat removal) during the study. (6) Have a history of depression, or other severe psychiatric disorders, or suicidal ideation or behavior. (7) Previously diagnosed with malignant tumors. (8) Have a history of any of the following cardiac diseases within 6 months prior to screening: decompensated heart failure (NYHA class III or IV); unstable angina, myocardial infarction, coronary artery bypass grafting, or coronary stent implantation. (9) Have a history of hemorrhagic or ischemic stroke within 6 months prior to screening, and deemed unsuitable by the investigator. (10) Have experienced severe hypoglycemia or recurrent (>=2 episodes within 6 months) symptomatic hypoglycemia within 6 months prior to screening. (11) Have uncontrolled hypertension despite treatment (systolic blood pressure >=160 mmHg and/or diastolic >=100 mmHg at screening), or have blood pressure meeting the above criteria without treatment. (12) Have thyroid dysfunction not controlled with a stable dose of medication, or have clinically significant abnormalities in thyroid function tests at screening that require initiation of treatment. (13) Have a history of other severe endocrine system diseases affecting glucose metabolism, such as multiple endocrine neoplasia, acromegaly, Cushing's syndrome. (14) Have acute or chronic cholecystitis at screening; or have cholelithiasis with symptoms or requiring treatment at screening; or have gallbladder polyps with symptoms or requiring treatment at screening. (15) Have a history of gastrointestinal disorders that may increase the participant's risk, such as abnormal gastric emptying (e.g., gastroparesis, pyloric stenosis, pyloric obstruction), severe chronic gastrointestinal disease (e.g., history of intestinal obstruction, active ulcer within 6 months); or have undergone gastrointestinal surgery within 12 weeks prior to screening, and deemed unsuitable by the investigator. (16) Have had infectious diseases, severe trauma, or major surgery within 4 weeks prior to screening, and deemed unsuitable by the investigator. 3. Have used any of the following drugs or treatments prior to screening: (1) Within 12 weeks prior to screening, used GLP-1 receptor agonists or similar drugs targeting the same pathway, including semaglutide, liraglutide, dulaglutide, exenatide, lixisenatide, benaglutide, loxenatide (GLP-1RA drugs), and tirzepatide (GLP-1/GIP dual agonist), or other investigational drugs containing GLP-1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Event (AE) / Serious Adverse Event (SAE); | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters;Pharmacodynamic indicators; | — |
Countries
China
Contacts
Public ContactJianchang He
Yunnan Provincial Hospital of Traditional Chinese Medicine
Outcome results
None listed