Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:39 PM
Ignite Modification Date:
2025-12-24 @ 1:39 PM
NCT ID:
NCT05813795
Eligibility Criteria:
Inclusion Criteria:
1. Male or female, 18-75 years old, inclusive;
2. BMI between 24.0 to 28.0 kg/m2 with at least one comorbidity, including prediabetes, hypertension, hyperlipidemia, fatty liver , obstructive sleep apnea syndrome, etc.; or BMI ≥ 28 kg/m2 with or without comorbidities.
3. Weight change of no more than 5% (based on self-report), with diet and exercise alone, within 3 months before screening.
4. Willing and able to maintain stable diet and exercise during the study period.
Exclusion Criteria:
1. Obesity induced by endocrine diseases such as hypothyroidism, Cushing Syndrome, etc.
2. History of bariatric surgery (except liposuction \>1 year ago) or planned bariatric surgery during the study period.
3. Within 3 months before screening, history of using the following drugs or treatments:
1. Any approved or unapproved weight-loss drugs or Chinese herbs or health products that affect body weight.
2. Any hypoglycemic medication.
3. Any medication that may cause significant weight gain, including systemic glucocorticoid treatment, tricyclic anti-depressants, anti-epileptic and antipsychotics.
4. Any investigational drug, vaccine, or medical device.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05813795
Study Brief:
Protocol Section:
NCT05813795