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 @ 7:50 PM
Ignite Modification Date:
2025-12-24 @ 7:50 PM
NCT ID:
NCT05536804
Eligibility Criteria:
Inclusion Criteria:
All participants with or without diabetes:
* Have a Body Mass Index (BMI) ≥27 kilogram/square meter (kg/m²) at screening
* Diagnosed with chronic kidney disease (CKD)
* Has an estimated glomerular filtration rate (eGFR) ≥25 to ≤60 ml/min/1.73 m² or eGFR ≥25 to ≤75 ml/min/1.73 m² if urine albumin-to-creatinine ratio (UACR) \>30 milligram/gram (mg/g)
* Have been receiving an angiotensin-converting enzyme (ACE) or angiotensin II receptor blockers (ARB) that is considered the maximal appropriate dose by the investigator for treatment of chronic kidney disease or hypertension (unless the participant has low blood pressure or hypotension)
Participants without diabetes:
* Have Hemoglobin A1c (HbA1c) \<6.5% at screening
Participants with Type 2 diabetes:
* Have been diagnosed at least 180 days prior to screening
* Have HbA1c ≤9.5% at screening
Exclusion Criteria:
All participants:
* Have a self-reported change in body weight \>5 kilogram (kg) within 90 days prior to screening.
* Have a prior or planned surgical treatment for obesity
* Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 180 days
* Have eGFR \<25 mL/min/1.73m² calculated by using creatinine-based chronic kidney disease epidemiology collaboration (CKD-EPI) equations, as determined by central laboratory at screening.
* Have a history of unstable or rapidly progressing renal disease according to investigator judgment
* Have a known clinically significant gastric emptying abnormality (for example, severe diabetic gastroparesis or gastric outlet obstruction) or chronically take drugs that directly affect GI motility)
* Have had a history of chronic or acute pancreatitis
Participants with T2D:
* Have history of proliferative diabetic retinopathy or diabetic macular edema or non-proliferative diabetic retinopathy that requires acute treatment.
* Have been diagnosed with type 1 diabetes (T1D) or have history of ketoacidosis or hyperosmolar state/coma
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05536804
Study Brief:
Protocol Section:
NCT05536804