Safety, Tolerability, Pharmacokinetics and Efficacy of LMB763 in Patients With NASH

Model scores of the 29,894 trials active now.

Model score 14% 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 2018-09-19. 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.

• Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: type diabetesmripriorpatientseffective
  Phrases that lowered it: pharmacokineticsmalehistoryscreeningsafety
• Sponsor's past termination rate: 14.4% (raises risk) · Sponsor's track record
• Accepts healthy volunteers: No (raises risk) · Who can join
• Phase: 2 (raises risk) · Design
• Sponsor's past trials: 937 (raises risk) · Sponsor's track record
• Blinding: triple (raises risk) · Design
• Design: parallel (raises risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
• Trials the sponsor started in the prior 2 years: 186 (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
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Number of arms: 2 (raises risk) · Design
• Disease area, neurology: No (lowers risk) · Disease area
• Maximum age: not given (lowers risk) · Who can join
• Collaborators: 0 (raises risk) · Design

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.

• A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BFKB8488A Compared With Placebo in Participants With Non-Alcoholic Steatohepatitis NCT04171765 · started 2020 · scored riskier than 26% of active trials terminated
• Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Participants With Nonalcoholic Steatohepatitis (NASH) NCT02854605 · started 2016 · scored riskier than 82% of active trials completed
• A Study to Evaluate the Efficacy and Safety of ALS-L1023 in Subjects With NASH NCT04342793 · started 2019 · scored riskier than 16% of active trials completed
• Study of PXL065 in Patients With Nonalcoholic Steatohepatitis (NASH) NCT04321343 · started 2020 · scored riskier than 12% of active trials completed
• A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-963272 in Participants With Nonalcoholic Fatty Liver Disease NCT04766476 · started 2021 · scored riskier than 37% 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.