| Trial ID: | L0456 |
| Source ID: | NCT04065841
|
| Associated Drug: |
Tropifexor
|
| 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
|
| Acronym: |
ELIVATE
|
| Status: |
Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Non Alcoholic Steatohepatitis (NASH)
|
| Interventions: |
Drug: Tropifexor;Drug: Licogliflozin;Other: Placebo
|
| Outcome Measures: |
Whether the participant achieves at least one stage of improvement in fibrosis without worsening of NASH (YES/NO);Whether the participant has resolution of NASH without worsening of fibrosis (YES/NO)Whether the participant achieves resolution of NASH and no worsening of fibrosis OR improvement in fibrosis by at least one stage without worsening of NASH (YES/NO);Whether the participant has at least one stage improvement in fibrosis (YES/NO);Whether the participant has at least two stage improvement in fibrosis without worsening of NASH (YES/NO);Whether the participant has 5% or more reduction in body weight (YES/NO);Change in liver fat content based on MRI - PDFF (in 40% of participants);Change in ALT and AST over time;Change in GGT over time;Occurrence of adverse events, serious adverse events, adverse events resulting in discontinuation of study treatment, adverse events of special interest and changes in vital signs and laboratory parameters
|
| Sponsor/Collaborators: |
Novartis Pharmaceuticals
|
| Gender: |
All
|
| Age: |
18 Yearsnan
|
| Phases: |
Phase 2
|
| Enrollment: |
380
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
|
| Start Date: |
19/08/2019
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
21 February 2022
|
| Locations: |
United States;Argentina;Belgium;Brazil;Bulgaria;Canada;Chile;China;Colombia;Denmark;Estonia;Germany;India;Italy;Japan;Korea, Republic of;Mexico;Puerto Rico;Russian Federation;Saudi Arabia;Singapore;Slovakia;South Africa;Spain;Taiwan;Turkey;United Kingdom;Argentina;Belgium;Brazil;Bulgaria;Canada;Chile;China;Colombia;Denmark;Estonia;Germany;India;Italy;Japan;Korea, Republic of;Mexico;Puerto Rico;Russian Federation;Saudi Arabia;Singapore;Slovakia;South Africa;Spain;Taiwan;Turkey;United Kingdom;United States
|
| URL: |
https://clinicaltrials.gov/show/NCT04065841
|
