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:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07391267
Eligibility Criteria:
Inclusion Criteria:
* 1.Age above or equal to 18 years at the time of signing informed consent. 2.Diagnosed with type 2 diabetes mellitus 3.HbA1c less than or equal to 10% (less than or equal to 86 mmol/mol) 4.Renal impairment defined either by:
* serum creatinine-based eGFR greater than or equal to 50 and less than or equal to 75 mL/min/1.73 m\^2 (CKD-EPI) and UACR greater than 300 and less than 5000 mg/g or
* serum creatinine-based eGFR greater than or equal to 25 and less than 50 mL/min/1.73 m\^2 (CKD-EPI) and UACR greater than 100 and less than 5000 mg/g 5.Treatment with maximum labelled or tolerated dose of a reninangiotensin-aldosterone system (RAAS) blocking agent including an angiotensin converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB), unless such treatment is contraindicated or not tolerated. Treatment dose must be stable for at least 4 weeks prior to the date of the laboratory assessments used for determination of the inclusion criteria for renal impairment and kept stable until screening.
Exclusion Criteria:
1. Documented causes of chronic liver disease other than non-alcoholic fatty liver disease (NAFLD)
2. Positive HBsAg, positive anti-HIV, positive HCV RNA at screening (V2A) or any known presence of HCV RNA or HBsAg within 2 years of screening (V2A).
3. Presence or history of ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis or liver transplantation at randomisation.
4. Known or suspected excessive consumption of alcohol (greater than 20 g/day for women or greater than 30 g/day for men) or alcohol dependence (assessed by the Alcohol Use Disorders Identification Test (AUDIT questionnaire)).
5. Treatment with vitamin E (at doses greater than or equal to 800 IU/day) or pioglitazone or medications approved for treatment of NASH which has not been at a stable dose in the period from 90 days prior to the screening visit (V2A). In addition, for subjects with historical liver biopsies taken more than 90 days prior to screening, treatment should be at a stable dose from time of biopsy until screening.
6. Treatment with GLP-1 RAs in the period from 90 days prior to the screening visit (V2A). In addition, for subjects with historical liver biopsies taken more than 90 days prior to screening, any treatment with GLP-1 RAs from time of biopsy until screening (V2A).
7. Treatment with glucose-lowering agent(s) (other than GLP-1 RAs), lipid-lowering medication or weight loss medication not stable in the opinion of the investigator in the period from 90 days prior to the screening visit (V2A). In addition, for subjects with historical liver biopsies taken more than 90 days prior to screening, treatment should be at a stable dose in the opinion of the investigator from time of biopsy until screening.
8. Congenital or hereditary kidney diseases including polycystic kidney disease, autoimmune kidney diseases including glomerulonephritis or congenital urinary tract malformations
9. Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 60 days prior to the day of screening.
10. Presently classified as being in New York Heart Association (NYHA) Class IV heart failure
11. Planned coronary, carotid or peripheral artery revascularisation
12. Current (or within 90 days) chronic or intermittent haemodialysis or peritoneal dialysis 13 Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupildilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
\-
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07391267
Study Brief:
Protocol Section:
NCT07391267