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

Non Alcoholic Steatohepatitis (NASH) Clinical Trial

Official title: 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)

Status Terminated

Clinical Trial 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.

Clinical Trial Description

The study consisted of 1) a screening period, 2) a treatment period starting from randomization on Day 0 and running to Week 48, and 3) a follow-up period of 4 weeks after the last dose of study treatment. The study duration from first dose of study medication was 52 weeks. ;

Related Conditions & MeSH terms

• Fatty Liver
• Liver Cirrhosis
• Non Alcoholic Steatohepatitis (NASH)
• Non-alcoholic Fatty Liver Disease

• NCT number: NCT04065841
• Study type: Interventional
• Source: Novartis
• Status: Terminated
• Phase: Phase 2
• Start date: December 30, 2019
• Completion date: October 27, 2022