Oral ecnoglutide tablets for weight management in Chinese adults with overweight or obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• China-Japan Friendship Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Jintong Li, Dr — China-Japan Friendship Hospital

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.