Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Elafibranor in Children and Adolescents with NASH
NCT03883607Phase 2
Key facts
- Status
- Terminated
- Start
- Jun 2019
- Primary completion
- Jun 2020
- Countries
- 1
- Sponsor
- Genfit
- Modality
- Small Molecules
- Drugs
- elafibranor
- Conditions
- Nonalcoholic steatohepatitis (NASH)
01
Overview
Phase 2, randomised, open-label trial of elafibranor in Nonalcoholic steatohepatitis (NASH) (2 arms), sponsored by Genfit. Primary endpoints: Maximum Observed Plasma Concentration at Day 85, Time to Maximum Observed Plasma Concentration at Day 85 and 3 more. Started Jun 2019; status: terminated.
02
Design
2 arms- Study design
- RandomizedOpen-label
Elafibranor 80 mg
Elafibranor 80 mg once daily
Elafibranor 120 mg
Elafibranor 120 mg once daily
03
Who it enrols
Children and adolescents (8-17 years) with histologically confirmed NASH, elevated ALT (>50 IU/L), insulin resistance (HOMA-IR >= 5), and BMI >= 85th percentile. Excludes patients with cirrhosis, other chronic liver diseases, type 1 diabetes, or renal disease.
04
Endpoints
Primary
Maximum Observed Plasma Concentration
Time to Maximum Observed Plasma Concentration
Area Under The Plasma Concentration-time Curve From 0 to 24 Hours
Terminal Elimination Half-life
Plasma Trough Concentrations
Secondary
Change From Baseline in Serum ALT, AST, GGT, and ALP
Change From Baseline in Adiponectin
Change From Baseline in CK-18/M65 and CK-18/M30
Change From Baseline in Ferritin
Change From Baseline in FGF19 and FGF21
Change From Baseline in HA, PIIINP, and TIMP1
Change From Baseline in FPG, HOMA-IR, Fasting Insulin
Change From Baseline in TC, Non-HDL-C, HDL-C, LDL-C, TG, VLDL-C, ApoA1, ApoB
Beyond the preview
Go deeper on NCT03883607.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT03883607.