Safety, Tolerability, and Efficacy of Monotherapy and Combination Regimens in Participants With Nonalcoholic Steatohepatitis (NASH)
Model scores of the 29,894 trials active now.
Model score 19% for any early termination, 2% 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.
How it ended
Completed on 2020-07-13, after 2019-07-29 start.
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2020-07-13. 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.
What moved the score
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Sponsor's past termination rate: 16.4% (raises risk) · Sponsor's track record
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: mriprimarytolerabilityimagingdisease including
Phrases that lowered it: participantsevaluate theto evaluatemultiplecarcinoma -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Drug's FAERS reports marked serious: 38.2% (lowers risk) · Drug's FDA history
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Phase: 2 (raises risk) · Design
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Design: parallel (raises risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 29 (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports with a death: 0.9% (lowers risk) · Drug's FDA history
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Number of arms: 5 (lowers risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Primary purpose: treatment (raises risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
-
Maximum age: 75 (raises risk) · Who can join
-
Collaborators: 1 (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.
The trial
Design
- Phase
- 2
- Number of arms
- 5 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 75 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 409 (typical: 32)
- Sponsor's past termination rate
- 16.4% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 29 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 1674 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1425 (typical: 412.5)
- Drug's FAERS reports marked serious
- 38.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 0.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- digestive
- Drugs matched to FDA substances
- cilofexor, firsocostat, semaglutide
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- Study of Various Treatments in Non-alcoholic Fatty Liver Disease (NAFLD) Patients Who Have Aspects of Non-alcoholic Steatohepatitis (NASH) NCT04147195 · started 2020 · scored riskier than 32% 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
- Study to Evaluate Safety, Tolerability, and Efficacy of GS-0976 in Adults With Nonalcoholic Steatohepatitis NCT02856555 · started 2016 · scored riskier than 96% of active trials completed
- A Multiple Ascending Dose Study of Pegozafermin in Participants With Biopsy Confirmed Nonalcoholic Steatohepatitis (NASH) or Nonalcoholic Fatty Liver Disease (NAFLD) and at High Risk of NASH NCT04048135 · started 2019 · scored riskier than 21% of active trials completed
- JKB-121 for the Treatment of Nonalcoholic Steatohepatitis NCT02442687 · started 2015 · scored riskier than 22% of active trials completed
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.