A Phase Ib/IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Ecnoglutide Tablets in Chinese Participants With Overweight or Obesity
Recruiting · NCT07243171 · Interventional (participants receive a specific treatment) · Lead sponsor: Hangzhou Sciwind Biosciences Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
ecnoglutide tabletsplacebo with matching dosage
What this trial is about
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
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 ;
Exclusion criteria
- 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.
- History of major gastrointestinal surgery (except cholecystectomy or appendectomy), or metabolic surgery, or plan to undergo major surgery during the study period;
- HbA1c ≥6.5% or fasting blood glucose ≥7.0 mmol/L, or OGTT 2-hour blood glucose ≥11.1 mmol/L, at screening;
- Clinical laboratory test results with clinical significance
Where it is running
1 location listed.
- China-Japan Friendship Hospital - Beijing, Beijing Municipality, China