NCT07243171 A Phase Ib/IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Ecnoglutide Tablets in Chinese Participants With Overweight or Obesity
| NCT ID | NCT07243171 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Hangzhou Sciwind Biosciences Co., Ltd. |
| Condition | Overweight and/or Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 84 participants |
| Start Date | 2025-11-18 |
| Primary Completion | 2026-08-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 84 participants in total. It began in 2025-11-18 with a primary completion date of 2026-08-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility 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
Contact & Investigator
Jintong Li, Dr
PRINCIPAL INVESTIGATOR
China-Japan Friendship Hospital
Frequently Asked Questions
Who can join the NCT07243171 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Overweight and/or Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07243171 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07243171 currently recruiting?
Yes, NCT07243171 is actively recruiting participants. Visit ClinicalTrials.gov or contact Hangzhou Sciwind Biosciences Co., Ltd. to inquire about joining.
Where is the NCT07243171 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07243171 clinical trial?
NCT07243171 is sponsored by Hangzhou Sciwind Biosciences Co., Ltd.. The principal investigator is Jintong Li, Dr at China-Japan Friendship Hospital. The trial plans to enroll 84 participants.
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