Live from ClinicalTrials.gov + Open Targets, fetched 2026-11-12 03:46 UTC. Every row links to its source record.
Postmortem · what the sponsor and named sources said, kept apart from what merely happened at the same time
Elafibranor, PK and Safety in Children and Adolescents 8 to 17 Years of Age With Non Alcoholic Steatohepatitis (NASH)
NCT03883607 · Genfit · PHASE2 · terminated · last registry update 2021-10-28 · Decision brief
No research has been run for this trial yet, so only the registry's own reason and the timeline are shown.
What was said, and by whom
Stated is the sponsor's own words; Reported is a named third party. The category is our label from a fixed list; the quote is the evidence.
| Kind | Quote | Our category | Source |
|---|---|---|---|
| Stated | “Due to lack of efficacy (but not due to safety) in a Phase 3 trial of elafibranor in adult participants with NASH and fibrosis, this study in pediatric NASH was prematurely terminated” | – | Registry record, Genfit |
Also happening at the time. Not shown to be a cause.
Registry events on other trials of drugs against PPARA within 12 months either side of this trial's last update, live from ClinicalTrials.gov. Nothing here was stated as a reason.
- 2022-10-28Results posted on the registry: Kowa Research Institute, Inc., K-877 + Fenofibrate (NCT03011450)
- 2022-04-25Results posted on the registry: Amarin Pharma Inc., AMR101 (ethyl icosapentate) - 4 g/day + AMR101 (ethyl icosapentate) - 2 g/day (NCT01047501)
- 2022-04-25Results posted on the registry: Amarin Pharma Inc., AMR101 (ethyl icosapentate) - 4 g/day + AMR101 (ethyl icosapentate) - 2 g/day (NCT01047683)
- 2022-04-14Results posted on the registry: Amarin Pharma Inc., AMR101 + Placebo (NCT01492361)
- 2022-03-23Results posted on the registry: Genfit, Elafibranor + Placebo (NCT02704403)
- 2022-03-23Also stopped (terminated): Genfit, Elafibranor + Placebo (NCT02704403)
- 2022-02-08Results posted on the registry: Medical University of South Carolina, Fenofibrate (NCT03829514)
- 2022-02-02Results posted on the registry: Gilead Sciences, SEL + FIR (NCT02781584)
- 2021-12-13Results posted on the registry: Merck Sharp & Dohme LLC, IMI/REL FDC (NCT03230916)
- 2021-11-24Phase 3 first posted: Zydus Therapeutics Inc., Saroglitazar Magnesium 1 mg + Saroglitazar Magnesium 2 mg (NCT05133336)
- 2021-10-29Also stopped (terminated): The Mind Research Network, Gemfibrozil 600 MG + Placebo oral capsule (NCT03539432)
- 2021-10-18Results posted on the registry: The Mind Research Network, Gemfibrozil 600 MG + Placebo oral capsule (NCT03539432)
- 2021-09-17Also stopped (withdrawn): Beijing 302 Hospital, Fenofibrate + UDCA (NCT02965911)
- 2021-08-10Phase 3 first posted: Kowa Company, Ltd., K-877 0.1 mg tablet + Fenofibrate 200 mg capsule (NCT04998981)
- 2021-05-11Phase 3 first posted: Laboratorios Silanes S.A. de C.V., Atorvastatin 20 mg / Fenofibrate 160 mg in fixed dose + Atorvastatin (Lipitor ®) (NCT04882293)
- 2021-03-19Phase 3 first posted: Chipscreen Biosciences, Ltd., Chiglitazar 32mg + Chiglitazar 48mg (NCT04807348)
- 2021-02-12Phase 3 first posted: Instituto Mexicano del Seguro Social, Bezafibrate 200 MG Oral Tablet + Placebo (NCT04751188)
- 2021-01-20Phase 3 first posted: Kowa Company, Ltd., K-877 ER 0.2 mg/day morning administration (once daily) + K-877 ER 0.2 mg/day evening administration (once daily) (NCT04716595)
- 2021-01-19Phase 3 first posted: Kowa Company, Ltd., K-877 ER 0.2 mg/day (once daily) + K-877 ER 0.4 mg/day (once daily) (NCT04714151)
- 2020-12-29Results posted on the registry: Sanofi, Alirocumab SAR236553 (REGN727) + Atorvastatin (NCT03510715)
- 2020-12-17Results posted on the registry: Gilead Sciences, Firsocostat + Fenofibrate (NCT02891408)
- 2020-12-10Phase 3 first posted: Jaeb Center for Health Research, Fenofibrate (NCT04661358)
- 2020-12-10Phase 3 first posted: Yaakov Nahmias, TriCor® 145mg tablets (NCT04661930)
- 2020-11-19Phase 3 first posted: Polaryx Therapeutics, Inc., PLX-200 + Placebo (NCT04637282)
What is not public
- Internal portfolio and board discussions
- Unpublished trial data and interim analyses
- Terms of any partner or licence decision