This is a randomized, double-blind, single-center, dose-escalation, single ascending dose and multiple ascending dose study of SYH9017 in Chinese participants with overweight and obesity.
Chinese male or female adult participants aged 18-60 years (inclusive) with overweight or obesity, with no less than one-third of the participants of either gender;
SAD phase: Body Mass Index (BMI) = weight (kg)/height² , with BMI in the range of 24.0-28.0 kg/m² (inclusive); MAD phase: Weight ≥70 kg (for males) or ≥60 kg (for females), and BMI = weight (kg)/height² , with BMI ≥28.0 kg/m²;
Weight change <5% in the 3 months prior to screening (can be based on self-report); calculated as: (weight 12 weeks before screening - weight at screening) / weight at screening * 100%;
Vital signs, physical examination, 12-lead electrocardiogram, chest X-ray (anteroposterior view), abdominal color Doppler ultrasound, clinical laboratory tests (complete blood count, urinalysis, blood biochemistry, glycated hemoglobin, coagulation function, infectious disease screening, thyroid function, calcitonin, etc.) show normal results or abnormal results deemed not clinically significant by the investigator;
A history of severe drug or food allergies, or any participant who is judged by the investigator to potentially be allergic to the investigational drug;
A history of significant diseases involving the pancreas, liver, kidneys, gastrointestinal tract, skin, cardiovascular system, respiratory system, hematological system, central nervous system, or other conditions that may endanger the safety of participants or affect the absorption, metabolism, or excretion of the study drug, and are deemed unsuitable for inclusion by the investigator;
A history of malignancy (except for cured basal cell carcinoma of the skin or carcinoma in situ of the cervix), psychiatric disorders (such as depression, schizophrenia, bipolar disorder, or a history of suicidal ideation or behavior), epilepsy, acute biliary disease, or confirmed acute or chronic pancreatitis; participants judged by the investigator to be unsuitable for participation in this clinical study;
Diagnosed with diabetes, thyroid dysfunction (abnormal TSH, FT3, or FT4 levels), Cushing's syndrome, polycystic ovary syndrome, a history of glucagonoma or pheochromocytoma, or other endocrine diseases that may affect glucose metabolism, or has experienced ≥2 episodes of severe hypoglycemia or recurrent symptomatic hypoglycemia;
Parallel
SYH9017
Drugsubcutaneous injection once time in SAD and four times in MAD
Placebo
Drugsubcutaneous injection once time in SAD and four times in MAD
Wegovy ®
Drugsubcutaneous injection once a week
Incidence of AEs following single-dose administration of SYH9017 Description:
Incidence of AEs following multiple doses administration of SYH9017AEs of SYH 9017 following multiple doses
The Cmax of SYH9017 following single-dose
The AUC of SYH9017 following single-dose
The Tmax of SYH9017 following single-dose
The t1/2 of SYH9017 following single-dose
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