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01
Overview
Phase 2, randomised, double-blind trial in diabetic nephropathy (DN) comparing LMB763 Arm with Placebo Arm (2 arms). Primary endpoints: Ratio to Baseline in Urinary Albumin to Creatinine Ratio (UACR) at Day 169, Ratio to Baseline in 24 Hour Urinary Albumin at Week 24 and 1 more. Started Dec 2018; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
LMB763 Arm
Nidufexor 50 mg QD + SoC
Placebo Arm
Placebo QD + SoC
03
Who it enrols
Patients with type 2 diabetes and diabetic nephropathy (UACR >= 300 mg/g) on stable standard of care (ACEI or ARB), excluding those with severe renal impairment (eGFR < 30) or uncontrolled diabetes.
04
Endpoints
Primary
Ratio to Baseline in Urinary Albumin to Creatinine Ratio (UACR)
Ratio to Baseline in 24 Hour Urinary Albumin at Week 24
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Secondary
Ratio to Baseline in Estimated Glomerular Filtration Rate (eGFR)
Maximum Peak Observed Concentration (Cmax) of LMB763
Time to Reach Maximum Blood Concentrations (Tmax) of LMB763
Area Under the Blood Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of LMB763
Ratio to Baseline in Free Water Clearance
Ratio to Baseline in Lipoprotein A
Percent Change From Baseline in Weight
Percent Change From Baseline in Body Mass Index (BMI)
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