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 @ 5:18 PM
Ignite Modification Date:
2025-12-24 @ 5:18 PM
NCT ID:
NCT06778850
Eligibility Criteria:
Inclusion Criteria:
* Participants who are aged ≥ 18 and ≤ 55 years at the time of signing the informed consent; no gender restriction.
* Participants with 27 ≤ body mass index (BMI) ≤ 45 kg/m2.
* For male participants, a waist circumference ≥ 90 cm is required, while female participants ≥ 85 cm.
Exclusion Criteria:
* Participants with any condition that increases the risk of bleeding, such as hemorrhoids, acute gastritis, or gastric and duodenal ulcers.
* Participants with personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia 2 (MEN2), or those with hereditary diseases that easily induce to medullary thyroid carcinoma.
* Participants with a history of pancreatitis or symptomatic gallbladder disease.
* Serum calcitonin \> ULN at screening.
* Participants with systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg at screening.
* Participants with ALT \>2 × ULN and /or AST \> 2 × ULN at screening.
* Participants whose fasting triglycerides \> 5.7 mmol/L, total cholesterol \> 7.75 mmol/L, low-density lipoprotein cholesterol \> 4.9 mmol/L at screening.
* Participants with abnormal uric acid levels accompanied by clinical symptoms (those without clinical symptoms can be included).
* Participants with fasting blood glucose levels \> 7 mmol/L.
* Participants with creatinine clearance \< 60 mL/min at screening \[calculation formula: CLcr: (140 - age) × weight (kg) / \[72 × 0.0113 × Scr (μmol/L)\], × 0.85 for females\].
* Participants have experienced significant changes in diet or exercise habits or within ≥5% changes in body weight within 3 months prior to screening.
* Participants with clinically significant ECG abnormality deemed unsuitable participation for study by the investigator; or with ECG QTcF values \> 450 ms for male participants or \> 470 ms for female participants.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT06778850
Study Brief:
Protocol Section:
NCT06778850