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:
2025-12-25 @ 4:51 AM
Ignite Modification Date:
2025-12-25 @ 4:51 AM
NCT ID:
NCT04844918
Eligibility Criteria:
Inclusion Criteria:
* Have a BMI of greater than or equal to ≥27 kg/m² and \<less than 35 kg/m² with at least 2 obesity-related health problems or ≥35 kg/m² with at least 1 obesity-related health problems. Health problems are IGT, hyperlipidemia, or NAFLD.
* Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.
Exclusion Criteria:
* Have diabetes.
* Acute or chronic liver disease other than NAFLD.
* Have a self-reported change in body weight \>5 kg within 3 months prior to screening.
* Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months.
* Have renal impairment measured as estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2, calculated by Japanese Society of Nephrology coefficient-modified Chronic Kidney Disease-Epidemiology equation during screening.
* Have a known clinically significant gastric emptying abnormality.
* Have had a history of chronic or acute pancreatitis.
* Have thyroid-stimulating hormone outside of the range of 0.4 to 6.0 micro units per milliliter (μIU/mL) at screening.
* Have obesity induced by other endocrinologic disorders or diagnosed monogenetic or syndromic forms of obesity.
* Have a history of significant active or unstable major depressive disorder or other severe psychiatric disorder within the last 2 years.
* Have a cardiovascular condition within 3 months prior to randomization
* Have a family or personal history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia Syndrome type 2.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT04844918
Study Brief:
Protocol Section:
NCT04844918