drugset / Trial / NCT04065841

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

NCT04065841 ↗

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

Outcome

Outcome not reported

Stopped (Business): “The sponsor made a business decision to stop development of the trial drugs. The decision to stop the trial early was not because of any safety concerns.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Tropifexor Small molecule 140 ug Oral
Subject licogliflozin Small molecule 30 mg Oral