Actively Recruiting
A Phase Ib/IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Ecnoglutide Tablets in Chinese Participants With Overweight or Obesity
Led by Hangzhou Sciwind Biosciences Co., Ltd. · Updated on 2026-01-28
84
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
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
CONDITIONS
Official Title
A Phase Ib/IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Ecnoglutide Tablets in Chinese Participants With Overweight or Obesity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- BMI between 24.0 and 35.0 kg/m2 at informed consent
- Body weight greater than 60.0 kg for males and greater than 50.0 kg for females
- Body weight change less than 5% in the 3 months before informed consent
You will not qualify if you...
- Overweight or obesity caused by endocrine disorders like Cushing's syndrome
- Significant endocrine disorders including hyperthyroidism, hypothyroidism, thyroid nodules (TI-RADS ≥ class 3), thyroid cancer, or type 2 multiple endocrine tumor syndrome (MEN2) history
- Significant cardiovascular or cerebrovascular diseases in the 6 months before screening, such as stroke, acute coronary syndrome, heart failure, or arrhythmia
- Severe gastrointestinal diseases including inflammatory bowel disease, active ulcers, irritable bowel syndrome, celiac disease, diabetic gastroparesis or diarrhea, and gastric emptying abnormalities
- History of major gastrointestinal or metabolic surgery, or planned major surgery during the study
- HbA1c ≥ 6.5%, fasting blood glucose ≥ 7.0 mmol/L, or OGTT 2-hour blood glucose ≥ 11.1 mmol/L at screening
- Clinically significant abnormal laboratory test results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China, 100029
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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