Cardiovascular Outcomes Study of Naltrexone SR/Bupropion SR in Overweight and Obese Subjects With Cardiovascular Risk Factors (The Light Study)
Model scores of the 29,894 trials active now.
Model score 22% for any early termination, 4% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 14% of the time (493 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
Terminated on 2015-08-31, after 2012-06-30 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 2015-08-31. 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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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: coronarysubjectscholesterolplacebomg dl
Phrases that lowered it: kgbodym2diseasesindex -
Sponsor's past termination rate: 16.7% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
-
Design: parallel (raises risk) · Design
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Minimum age: 45 (lowers risk) · Who can join
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Blinding: quadruple (lowers risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
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Disease area, cardiovascular: Yes (raises risk) · Disease area
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Primary purpose: treatment (raises risk) · Design
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Phase: 3 (lowers risk) · Design
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Sponsor's past trials: 12 (lowers risk) · Sponsor's track record
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Collaborators: 0 (raises risk) · Design
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Disease area, neurology: No (lowers risk) · Disease area
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Maximum age: not given (raises risk) · Who can join
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
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 15 (typical: 1)
Who can join
- Minimum age
- 45 (typical: 18)
- Maximum age
- not given (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
- 12 (typical: 32)
- Sponsor's past termination rate
- 16.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 0 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 0 (typical: 1)
- Drug has FAERS history
- No (typical: 64% yes)
- Drug's FAERS reports before start
- 0 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 0 (typical: 412.5)
- Drug's FAERS reports marked serious
- no FAERS history (typical: 85.6%)
- Drug's FAERS reports with a death
- no FAERS history (typical: 15.9%)
Disease area and drugs
- Disease areas
- cardiovascular, metabolic, endocrine
- Drugs matched to FDA substances
- bupropion naltrexone
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
- Method-of-Use Study Assessing the Effect of Naltrexone Sustained Release (SR)/ Bupropion SR on Body Weight and Cardiovascular Risk Factors in Overweight and Obese Subjects NCT01764386 · started 2013 · scored riskier than 40% of active trials completed
- A Study of Naltrexone SR/ Bupropion SR in Overweight or Obese Subjects With Major Depression NCT00624858 · started 2008 · scored riskier than 11% of active trials completed
- A Weight Loss Study in Overweight Men and Women NCT00993421 · started 2009 · scored riskier than 28% of active trials terminated
- Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity: Medication Change for Non-Responders NCT03946111 · started 2019 · scored riskier than 27% of active trials completed
- A Study Using Functional Magnetic Resonance Imaging (fMRI) to Assess the Effects of Naltrexone SR/ Bupropion SR Therapy in Overweight or Obese Subjects NCT00711477 · started 2008 · scored riskier than 12% 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.