A Phase Ib/IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Ecnoglutide Tablets in Chinese Participants With Overweight or Obesity
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
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
Inclusion Criteria:
1. 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;
2. Self-declaration of body weight change \<5% within 3 months prior to informed consent ;
Exclusion Criteria:
1. Diagnosis of overweight or obesity due to endocrine disorders , such as Cushing's syndrome;
2. 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.
3. 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.
4. 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.
5. History of major gastrointestinal surgery (except cholecystectomy or appendectomy), or metabolic surgery, or plan to undergo major surgery during the study period;
6. HbA1c ≥6.5% or fasting blood glucose ≥7.0 mmol/L, or OGTT 2-hour blood glucose ≥11.1 mmol/L, at screening;
7. Clinical laboratory test results with clinical significance
Primary outcome measure(s)
The incidence and severity of adverse events — up to day 204
Trial sites (1)
Facility
City
Region
Status
China-Japan Friendship Hospital
Beijing
Beijing Municipality
Recruiting
More Hangzhou Sciwind Biosciences Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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