Efficacy of TAK-085 in Participants With Hypertriglyceridemia
Model scores of the 29,894 trials active now.
Model score 10% for any early termination, 1% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 9% of the time (803 trials).
Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Completed on 2010-12-31, after 2009-11-30 start.
The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
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 2010-12-31. 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: 14.6% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Minimum age: 20 (lowers risk) · Who can join
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Phase: 3 (lowers risk) · Design
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: coronaryaorticwithin monthsarterymonths prior
Phrases that lowered it: and safetysafety ofefficacy andevaluate thethe efficacy -
Drug's FAERS reports with a death: 16% (lowers risk) · Drug's FDA history
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Design: parallel (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 45 (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Has a data monitoring committee: No (lowers risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Maximum age: 74 (lowers risk) · Who can join
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Sponsor's past trials: 164 (lowers risk) · Sponsor's track record
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Blinding: quadruple (lowers risk) · Design
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Number of arms: 3 (lowers risk) · Design
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Drug's FAERS reports marked serious: 96% (raises risk) · Drug's FDA history
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Disease area, neurology: No (lowers 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.
The trial
Design
- Phase
- 3 (typical: 2)
- Number of arms
- 3 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 1
Who can join
- Minimum age
- 20 (typical: 18)
- Maximum age
- 74 (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
- 164 (typical: 32)
- Sponsor's past termination rate
- 14.6% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 45 (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
- 25 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 16 (typical: 412.5)
- Drug's FAERS reports marked serious
- 96% (typical: 85.6%)
- Drug's FAERS reports with a death
- 16% (typical: 15.9%)
Disease area and drugs
- Disease areas
- metabolic
- Drugs matched to FDA substances
- omega3 acid ethyl esters
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
- Long-term Efficacy and Safety Study of TAK-085 in Participants With Hypertriglyceridemia NCT01350999 · started 2009 · scored riskier than 12% of active trials completed
- Efficacy of MND-2119 in Participants With Hypertriglyceridemia NCT03693131 · started 2018 · scored riskier than 7% of active trials completed
- A Study of Olezarsen (ISIS 678354) in Participants With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease, or With Severe Hypertriglyceridemia NCT05610280 · started 2022 · scored riskier than 68% of active trials completed
- Study to Explore the Efficacy and Safety of BIO89-100 (Pegozafermin) in Participants With Severe Hypertriglyceridemia NCT04541186 · started 2020 · scored riskier than 16% of active trials completed
- A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia NCT05552326 · started 2022 · scored riskier than 37% 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.