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 @ 9:38 PM
Ignite Modification Date:
2025-12-24 @ 9:38 PM
NCT ID:
NCT07230132
Eligibility Criteria:
Inclusion Criteria:
* Male or female, age between 18 - 65 years (both inclusive) at the time of signing of the informed consent.
* Body mass index (BMI) greater than or equal to 28 kg/m², or greater than or equal to 24 kg/m²with at least one of the comorbidities: hypertension, hyperlipidemia, pre-diabetes, metabolic dysfunction-associated steatotic liver disease (MASLD) or obstructive sleep apnea-hypopnea syndrome (OSAHS).
* Having dietary caloric restriction and increased physical activity for ≥3 months, with change in body weight (increase or decrease) no more than 5%, irrespective of medical records.
Exclusion Criteria:
* Type 1 or type 2 diabetes or other specific types derived from other causes
* Medical history of acute or chronic pancreatitis
* Medical history of cholecystitis, gallstone ≤1 cm, or history of symptomatic gallbladder diseases
* Use of glucagon-like peptide-1 (GLP-1) agonist, dual GLP-1/glucose-dependent insulinotropic polypeptide (GIP) or GLP-1/glucagon agonist, or triple GLP-1/GIP/glucagon agonist within 90 days before screening
* HbA1c ≥ 6.5% or fasting plasma glucose ≥ 7.0 mmol/L at screening
* Triglyceride ≥ 5.7 mmol/L at screening
* Calcitonin ≥ 50 ng/L at screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07230132
Study Brief:
Protocol Section:
NCT07230132