Safety, Tolerability and Efficacy of Nidufexor in Patients With Diabetic Nephropathy

A Randomized Patient-and-physician Blinded, Placebo-controlled, 24-week Study to Assess the Safety, Tolerability and Efficacy of LMB763 in Patients With Diabetic Nephropathy

ClinicalTrials.gov Identifier: NCT03804879

Novartis Reference Number: CLMB763X2202

Last Update: Dec 24, 2020

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.

Study Description

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.

Condition

Diabetic Nephropathy

Phase

Phase 2

Overall status

Recruiting

Enrollment count

116 participants

Start date

Dec 17, 2018

Completion date

May 18, 2022

Gender

All

Age(s)

18 Years - 75 Years (Adult, Older Adult)

Interventions

Drug

LMB763

LMB763 capsule

Other

Placebo

Placebo capsule

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.