Placebo-controlled, Proof-of-concept Study to Evaluate the Safety and Efficacy of Lanifibranor Alone and in Combination With SGLT2 Inhibitor EmpaGliflozin in patiEnts With NASH and Type 2 Diabetes Mellitus

Model scores of the 29,894 trials active now.

Model score 12% for any early termination, 3% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 18% of the time (280 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2024-06-04. The rest of the way to 100% is still running.

From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.

• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: metforminmriglycemicdiagnosis oftreatment with
  Phrases that lowered it: effectthe investigatordaydoseshepatic
• Phase: 2 (raises risk) · Design
• Drug's FAERS reports marked serious: 57.5% (lowers risk) · Drug's FDA history
• Design: parallel (raises risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Blinding: quadruple (lowers risk) · Design
• Drug's FAERS reports with a death: 3.4% (lowers risk) · Drug's FDA history
• Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
• Number of arms: 3 (lowers risk) · Design
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Minimum age: 18 (raises risk) · Who can join
• Primary purpose: treatment (raises risk) · Design
• Has a data monitoring committee: No (lowers risk) · Design
• Disease area, neurology: No (lowers risk) · Disease area
• Disease area, digestive: Yes (raises risk) · Disease area

Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.

• Lanifibranor in Patients With Type 2 Diabetes & Nonalcoholic Fatty Liver Disease NCT03459079 · started 2018 · scored riskier than 28% of active trials completed
• A Study to Evaluate Safety and Pharmacodynamic Efficacy of 0382 in Obese Subjects With NAFLD/NASH. NCT04019561 · started 2019 · scored riskier than 72% of active trials completed
• Efficacy and Safety of Dapagliflozin in Patients with Non-alcoholic Steatohepatitis NCT05254626 · started 2022 · scored riskier than 26% of active trials completed
• The Impact Of SGLT2 -I on Metabolic Dysfunction -Associated Steatotic Liver Disease In Patients With Type 2 Diabetes Mellitus NCT06117137 · started 2023 · scored riskier than 7% of active trials completed
• A Randomized, Double-blind Study to Assess the Safety and Efficacy of EDP-305 in Subjects With Liver-biopsy Proven NASH NCT04378010 · started 2020 · scored riskier than 51% of active trials terminated

Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.