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Clinical Trials and Studies
Novartis trial NCT02855164 (phase 2 randomized controlled trial with double blinding and multiple sites designed to assess the safety, tolerability, and efficacy of tropifexor in adult patients with NASH)
CLJC242A2201J: A Randomized, Double-blind, Multicenter Study to Assess the Safety, Tolerability, and Efficacy of a Combination Treatment of Tropifexor (LJN452) and Cenicriviroc (CVC) in Adult Patients With Nonalcoholic Steatohepatitis (NASH) and Liver Fibrosis (TANDEM)
CLJN452D12201C: A Randomized, Double-blind, Parallel-group, Multicenter Study to Assess Efficacy, Safety, and Tolerability of Oral Tropifexor (LJN452) & Licogliflozin (LIK066) Combination Therapy and Each Monotherapy, Compared With Placebo for Treatment of Adult Patients With Nonalcoholic Steatohepatitis (NASH) and Liver Fibrosis.(ELIVATE)
CLJN452A2202: A Randomized, Double-blind, Placebo Controlled, 3- Part, Adaptive Design, Multicenter Study to Assess Safety, Tolerability and Efficacy of Tropifexor (LJN452) in Patients With Non-alcoholic Steatohepatitis (NASH): FLIGHT-FXR
Non-Interventional Studies
- European NAFLD Registry
- A prospectively recruited, international observational study across the full spectrum of NAFLD (clinicaltrials.gov registration NCT04442334)
- References:
Hardy T, Wonders K, Younes R, Aithal GP, Aller R, Allison M, Bedossa P, Betsou F, Boursier J, Brosnan MJ, Burt A, Cobbold J, Cortez-Pinto H, Day CP, Dufour JF, Ekstedt M, Francque S, Harrison S, Miele L, Nasr P, Papatheodoridis G, Petta S, Tiniakos D, Torstenson R, Valenti L, Holleboom AG, Yki-Jarvinen H, Geier A, Romero-Gomez M, Ratziu V, Bugianesi E, Schattenberg JM, Anstee QM. The European NAFLD Registry: A real-world longitudinal cohort study of nonalcoholic fatty liver disease. Contemporary Clinical Trials. 2020, 98: 106175. ISSN 1551-7144, doi: 10.1016/j.cct.2020.106175
- TARGET-NASH
- A longitudinal observational cohort study of patients being managed for NASH and related conditions across the entire spectrum NAFLD in usual clinical practice (clinicaltrials.gov registration NCT02815891).
