The aim of the study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of oral ecnoglutide tablets in Chinese participants with overweight or obesity
At the time of informed consent, with BMI in the range of 24.0 to 35.0 kg/m2 (including the threshold), body weight >60.0 kg for male, and weight >50.0 kg for female;
Self-declaration of body weight change <5% within 3 months prior to informed consent ;
Diagnosis of overweight or obesity due to endocrine disorders , such as Cushing's syndrome;
Diagnosis of other endocrine disorders with clinical significance, including but not limited to hyperthyroidism or hypothyroidism, thyroid nodules (imaging shows TI-RADS≥ class 3), thyroid cancer, or personal or family history of type 2 multiple endocrine tumor syndrome (MEN2), etc.
Diagnosis of cardiovascular or cerebrovascular diseases with clinical significance within 6 months prior to screening, including but not limited to acute stroke, acute coronary syndrome, heart failure, arrhythmia, etc.
Diagnosis of severe gastrointestinal diseases, including but not limited to inflammatory bowel disease, active ulcers, irritable bowel syndrome, celiac disease, dyspepsia, diabetic gastroparesis, diabetic diarrhea, clinical gastric emptying abnormalities (such as pyloric obstruction), etc.
Parallel
ecnoglutide tablets
Drugoral tablets
placebo with matching dosage
Drugoral tablets
6
Treatment groupsSee each treatment group below.
The incidence and severity of adverse events
Pharmacokinetics of oral ecnoglutide tablet
Cmax, Tmax and AUC
Change of body weight from baseline
Change of BMI from baseline
Change of waist circumference from baseline
Immunogenecity of oral ecnoglutide tablet
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