A Dose-finding Trial of ETC-1002(Bempedoic Acid) in Patients With Hypercholesterolemia

NCT04784442 on ClinicalTrials.gov Phase 2 Otsuka Pharmaceutical Co., Ltd. (industry) Started 2021-03-24 Completed

Riskier than 13% of active trials

Model scores of the 29,894 trials active now.

Model score 9% 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 11% of the time (493 trials).

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

How it ended

Completed on 2022-05-17, after 2021-03-24 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 2022-05-17. 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

Sponsor's past termination rate: 2.9% (lowers risk) · Sponsor's track record
Minimum age: 20 (lowers risk) · Who can join
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 2 (raises risk) · Design
Blinding: quadruple (lowers risk) · Design
Design: parallel (raises risk) · Design
Number of arms: 4 (lowers risk) · Design
Has a data monitoring committee: No (lowers risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Drug's FAERS reports with a death: 0% (lowers risk) · Drug's FDA history
Sponsor type: industry (lowers risk) · Sponsor's track record
Sponsor's past trials: 105 (lowers risk) · Sponsor's track record
Primary purpose: treatment (raises risk) · Design
Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: may applycriteria mayscreeningstablesyndrome
Phrases that lowered it: efficacy andand safetysafety oftrialldl
Drug's FAERS reports marked serious: 15.3% (lowers risk) · Drug's FDA history
Maximum age: 74 (lowers risk) · Who can join
Trials the sponsor started in the prior 2 years: 12 (lowers risk) · Sponsor's track record

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: 4 (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: 0 (typical: 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: 105 (typical: 32)
Sponsor's past termination rate: 2.9% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 12 (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: 190 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 182 (typical: 412.5)
Drug's FAERS reports marked serious: 15.3% (typical: 85.6%)
Drug's FAERS reports with a death: 0% (typical: 15.9%)

Disease area and drugs

Disease areas: metabolic
Drugs matched to FDA substances: bempedoic acid

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

A Long-term Trial of ETC-1002 in Patients With Hyper-LDL Cholesterolemia NCT05687071 · started 2023 · scored riskier than 19% of active trials completed
A Confirmatory Trial of ETC-1002 in Patients With Hyper-LDL Cholesterolemia NCT05683340 · started 2023 · scored riskier than 11% of active trials completed
Evaluation of Long-Term Safety and Tolerability of ETC-1002 in High-Risk Patients With Hyperlipidemia and High CV Risk (CLEAR Harmony) NCT02666664 · started 2016 · scored riskier than 18% of active trials completed
A Study of the Efficacy and Safety of ETC-1002 in Participants With Statin Intolerance NCT01751984 · started 2012 · scored riskier than 12% of active trials completed
A Study to Evaluate the Effectiveness of Ezetimibe/Atorvastatin 10 mg/40 mg Combination Tablet Compared to Marketed Ezetimibe 10 mg and Atorvastatin 40 mg Tablets in Participants With High Cholesterol (MK-0653C-190 AM1) NCT01370603 · started 2011 · scored riskier than 10% 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.