Oral ecnoglutide tablets for weight management in Chinese adults with overweight or obesity
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
This trial will test whether daily or weekly oral ecnoglutide tablets help Chinese adults with overweight or obesity and are safe and well tolerated.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Hangzhou Sciwind Biosciences Co., Ltd. Industry-sponsored |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT07243171 on ClinicalTrials.gov |
What this trial studies
This randomized, placebo-controlled Phase Ib/IIa study enrolls Chinese adults with BMI 24.0–35.0 kg/m2 and predefined weight thresholds to receive oral ecnoglutide or matching placebo. Participants are assigned to one of four cohorts: short daily dosing for 3–4 weeks or once-weekly dosing including a dose-escalation period for up to 24 weeks. The study measures safety, tolerability, pharmacokinetics, and pharmacodynamics of oral ecnoglutide compared with placebo. Study visits are conducted at the China-Japan Friendship Hospital in Beijing under the sponsor Hangzhou Sciwind Biosciences Co., Ltd.
Who should consider this trial
Good fit: Ideal candidates are Chinese adults with BMI between 24.0 and 35.0 kg/m2 who meet the study's minimum weight thresholds and have had less than 5% body-weight change in the prior 3 months.
Not a fit: Patients with endocrine causes of obesity, significant cardiovascular or cerebrovascular disease within 6 months, severe gastrointestinal disease, or other major excluded conditions are unlikely to be eligible or to benefit from participation.
Why it matters
Potential benefit: If successful, oral ecnoglutide could provide a convenient non-injectable GLP-1 option to help reduce weight and improve metabolic health for patients with overweight or obesity.
How similar studies have performed: Other oral GLP-1 drugs such as oral semaglutide have shown meaningful weight-loss benefits in prior trials, but oral ecnoglutide is a newer agent with relatively limited prior human data.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Beijing, Beijing Municipality
- China-Japan Friendship Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Jintong Li, Dr — China-Japan Friendship Hospital
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.