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A Multicenter, Multiple-dose Escalation, Randomized, Double-blind, Placebo-controlled 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
15 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying oral ecnoglutide tablets to understand their safety, tolerability, how the body processes the drug, and its effects in Chinese adults with overweight or obesity. This trial aims to provide information on these tablets for weight management and metabolic health. The study is a Phase Ib/IIa randomized, double-blind, placebo-controlled trial sponsored by Hangzhou Sciwind Biosciences Co., Ltd.
CONDITIONS
Brief 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 the time of consent
- Body weight over 60.0 kg for males, over 50.0 kg for females
- Self-reported body weight change less than 5% within 3 months prior to consent
You will not qualify if you...
- Overweight or obesity caused by endocrine disorders like Cushing's syndrome
- Other significant endocrine disorders such as hyperthyroidism, hypothyroidism, thyroid nodules (TI-RADS class 3 or higher), thyroid cancer, or personal/family history of type 2 multiple endocrine tumor syndrome (MEN2)
- Cardiovascular or cerebrovascular diseases with clinical significance within 6 months before screening, including acute stroke, acute coronary syndrome, heart failure, or arrhythmia
- Severe gastrointestinal diseases such as inflammatory bowel disease, active ulcers, irritable bowel syndrome, celiac disease, diabetic gastroparesis, diabetic diarrhea, or clinical gastric emptying abnormalities
- History of major gastrointestinal surgery (except cholecystectomy or appendectomy), metabolic surgery, or planned major surgery during the study
- HbA1c equal to or above 6.5%, fasting blood glucose equal to or above 7.0 mmol/L, or OGTT 2-hour blood glucose equal to or above 11.1 mmol/L at screening
- Clinical laboratory test results with clinical significance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 weeks depending on cohort
Participants receive oral ecnoglutide tablets or placebo once daily or once weekly with dose escalation depending on their cohort assignment.
Weekly visits during treatment
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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