Efficacy, Safety and Tolerability of the Combination of Tropifexor & Licogliflozin and Each Monotherapy, Compared With Placebo in Adult Patients With NASH and Liver Fibrosis.

Phase 2 Terminated 234 enrolled Novartis Pharmaceuticals

RandomizedSequentialQuadruple-blindTreatment

Summary

Randomized, double-blind, parallel-group, multicenter study to assess efficacy, safety, and tolerability of oral tropifexor \& licogliflozin combination therapy and each monotherapy, compared with placebo for treatment of adult patients with nonalcoholic steatohepatitis (NASH) and liver fibrosis.

Timeline

Start: 2019-12-30
Primary completion: 2022-10-27
Completion: 2022-10-27

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tropifexor	Small molecule	140 ug	Oral
Subject	licogliflozin	Small molecule	30 mg	Oral

Efficacy, Safety and Tolerability of the Combination of Tropifexor & Licogliflozin and Each Monotherapy, Compared With Placebo in Adult Patients With NASH and Liver Fibrosis.

Summary

Timeline

Drugs

Indications