All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.
Nidufexor addresses fibrosis, oxidative stress, inflammation and cell death, and therefore has the potential to improve the management of diabetic kidney disease when added to the standard of care (angiotensin converting enzyme inhibitor or angiotensin receptor blocker). This non-confirmatory Phase 2 study is designed to determine the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of nidufexor in combination with angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) at a dose level that is standard of care as judged by the study doctor in patients with type 2 diabetes and nephropathy.
Dec 17, 2018
May 18, 2022
18 Years - 75 Years (Adult, Older Adult)
Male/female patients, 18-75 years
Written informed consent
Diagnosis of Type 2 diabetes mellitus, with diagnosis made at least 6 months prior to screening
Diabetic nephropathy as evidenced by Urine albumin-Cr ratio (UACR) ≥300 mg/g Cr at screening while receiving a dose of angiotensin converting enzyme inhibitor or angiotensin receptor blocker that is the standard of care as judged by the study doctor.
History of type 1 diabetes mellitus
Severe renal impairment manifesting as serum creatinine eGFR < 30 mL/min/1.73 m^2 at screening
Pregnant or nursing (lactating) women
Women of child-bearing potential, unless they are using basic methods of contraception during dosing of study treatment
Uncontrolled diabetes mellitus at screening
History or current diagnosis of ECG abnormalities prior to first study dose
History of kidney disease other than diabetic nephropathy at screening
Uncontrolled hypertension at screening
Use of prohibited medications, including but not limited to GLP-1 agonists and SGLT2 inhibitors.