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FLIGHT-FXR: Tropifexor in NASH
NCT02855164Phase 2
Key facts
- Status
- Terminated
- Start
- Aug 2016
- Primary completion
- Apr 2020
- Countries
- 17
- Sponsor
- Novartis
- Modality
- Small Molecules
- Drugs
- tropifexor
- Conditions
- Nonalcoholic steatohepatitis (NASH)
01
Overview
Phase 2, randomised, double-blind trial of tropifexor in Nonalcoholic steatohepatitis (NASH) (11 arms), sponsored by Novartis. Primary endpoints: Treatment Emergent Adverse Events at 48 weeks, Change in Alanine Aminotransferase at 48 weeks and 2 more. Started Aug 2016; status: terminated.
02
Design
11 arms- Study design
- RandomizedDouble-blind
Part A: Tropifexor 10 μg
Tropifexor 10 μg daily for 12 weeks
Part A: Tropifexor 30 μg
Tropifexor 30 μg daily for 12 weeks
Part A: Tropifexor 60 μg
Tropifexor 60 μg daily for 12 weeks
Part A: Tropifexor 90 μg
Tropifexor 90 μg daily for 12 weeks
Part A: Placebo
Placebo daily for 12 weeks
Part B: Tropifexor 90 μg
Tropifexor 90 μg daily for 12 weeks
5 more in the full profile.
03
Who it enrols
Adult patients with NASH (histologically confirmed or phenotypic diagnosis for Parts A/B; histologically confirmed for Part C) with fibrosis stage F1-F3 (Parts A/B) or F2-F3 (Part C), elevated ALT, and liver fat >= 10%.
04
Endpoints
Primary
Treatment Emergent Adverse Events
Change in Alanine Aminotransferase
Change in Aspartate Aminotransferase
Change in Liver Fat Content by MRI
Secondary
Change in Body Weight
Change in Body Mass Index
Change in Fibroblast Growth Factor 19
Change in 7alpha-hydroxy-4-cholesten-3-one
Histologic Fibrosis Improvement
Resolution of Steatohepatitis
Pruritus Visual Analog Scale Score
05
Results
Not all primary endpoints met
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