Registered ongoing clinical trials on CVC in patients with NAFLD

ID, registration date (DD/MM/YYYY)* Title Design Arms Patients (n) Duration Primary outcome(s)
NCT03517540 09/04/2018 OR EUCTR2017-004208 24 21/06/2018 OR CTRI/2019/01/017014 09/01/2019 A Randomized, Double-blind, Multicenter Study to Assess the Safety, Tolerability, and Efficacy of a Combination Treatment of Tropifexor (LJN452) and CVC in Adult Patients With NASH and Liver Fibrosis (TANDEM) Multicenter, randomized, double-blind, phase 2 Tropifexor 140 μg vs. CVC 150 mg vs. Tropifexor 140 μg + CVC 150 mg vs. Tropifexor 90 μg + CVC 150 mg 200 12 months Number of participants with adverse events
NCT03376841 2/8/2017 An Open-Label Study to Evaluate the Effect of Severe Hepatic Impairment on the Pharmacokinetics of CVC and Its Metabolites Following Single Dose Administration Single-center, non-randomized, open label, phase 1 CVC (single dose; NA mg) 16 6 days 1) AUC from time 0 to time t (AUC0-t)
2) AUC from time 0 to infinity (AUC0-∞)
3) Maximum plasma drug concentration (Cmax)
NCT03059446 3/2/2017 Open-label Rollover Study of CVC for the Treatment of Liver Fibrosis in Adult Subjects With NASH Multicenter, single group, open label, phase 2 CVC 150 mg 560 24 months Number of participants with adverse events
NCT03028740 13/1/2017 OR EUCTR2016-004566-26 22/02/2017 OR PER-041-17 02/04/2018 A Phase 3 Study to Evaluate the Efficacy and Safety of CVC for the Treatment of Liver Fibrosis in Adult Subjects With NASH (AURORA) Multicenter, randomized, double-blind, phase 3 CVC 150 mg vs. placebo 2000 12 months (for endpoint #1); 60 months (for endpoint #2) 1) Improvement in fibrosis ≥1 stage without worsening of NASH
2) Composite outcome of all-cause mortality, cirrhosis, HCC, liver thransplantation and other liver-related events
NCT02342067 12/1/2015 A Phase 1, Multiple-Dose, Open-Label, Randomized, Crossover Study in Healthy Subjects to Assess the Effect of PGZ on the PK of CVC and the Effect of CVC on the PK of PGZ Single-center, randomized, open-label, phase 1 CVC 150 mg, then PGZ 45 mg, then CVC + PGZ vs. PGZ 45 mg, then CVC 150 mg, then CVC + PGZ 20 40 days PK Assessment of CVC and PGZ, as measured by Cmax, Cmin and AUC
NCT02330549 22/12/2014 Effect of CCR2 and CCR5 Antagonism by CVC on Peripheral and Adipose Tissue Insulin Sensitivity in Adult Obese Subjects With Prediabetes or Type 2 Diabetes Mellitus and Suspected NAFLD (ORION) Multicenter, randomized, double-blind, phase 2 CVC 150 mg vs. placebo 45 6 months Changes in insulin sensitivity (peripheral and adipose tissue)

References are presented in date of registration order (newer to older); AUC: area under the curve; Cmax: maximum plasma drug concentration; Cmin: minimum plasma drug concentration; NA: not available; PGZ: pioglitazone; PK: pharmacokinetics