Trial · NCT04784442

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

NCT04784442, Phase 2, Completed, Otsuka Pharmaceutical Co., Ltd.; results first posted 2024-03-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Dose-finding Trial of ETC-1002(Bempedoic Acid) in Patients With Hypercholesterolemia. Trials, record NCT04784442. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04784442

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Dose-finding Trial of ETC-1002(Bempedoic Acid) in Patients With Hypercholesterolemia
NCT number: NCT04784442
Status: Completed
Phases: Phase 2
Enrollment: 188 participants, actual
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Conditions: Hypercholesterolemia
Interventions: 180mg of ETC-1002(bempedoic acid), 120mg of ETC-1002(bempedoic acid), 60mg of ETC-1002(bempedoic acid), Placebo
First posted: 2021-03-05
Last updated: 2024-05-10
Results first posted: 2024-03-04

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percent Change in LDL-C From Baseline to Week 12	Baseline, week12	Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100. Baseline was defined as the mean of the values from Week -1 and Day 1. When LDL-C at Week 12 was missing, the missing value was imputed using the last observation carried forward from the start of the IMP administration to 2 days after the final IMP administration.
Secondary	Percent Change in HDL Cholesterol From Baseline to Week 12	Baseline, week12	Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100.
Secondary	Percent Change in Non-HDL Cholesterol From Baseline to Week 12	Baseline, week12	Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100.
Secondary	Percent Change in Total Cholesterol From Baseline to Week 12	Baseline, week12	Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100.
Secondary	Percent Change in Triglycerides From Baseline to Week 12	Baseline, week12	Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100.
Secondary	Percent Change in Apolipoprotein B From Baseline to Week 12	Baseline, week12	Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100.
Secondary	Percent Change in High Sensitivity C Reactive Protein From Baseline to Week 12	Baseline, week12	Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100.
Secondary	Percent Change in Hemoglobin A1c From Baseline to Week 12	Baseline, week12	Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100.
Secondary	Proportion of Subjects Whose LDL-C Value Achieved the Lipid Management Goals Based on Risk Assessment at Week 12	Baseline, week12	The proportion of subjects whose LDL-C value achieves the lipid management goal at Week 12.
Secondary	Proportion of Subjects Whose LDL-C Value Achieve < 70 mg/dL at Week 12	Baseline, week12	The proportion of subjects whose LDL-C value achieves \<70 mg/dL at Week 12.

Source ClinicalTrials.gov

Outcomes10

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percent Change in LDL-C From Baseline to Week 12	Baseline, week12	The FAS included all subjects who receive at least one dose of IMP during the treatment period and for whom LDL-C values at baseline and at least one post-dose (up to 2 days after final IMP administration) are observed.	Percent Change	LEAST_SQUARES_MEAN
SECONDARY	Percent Change in HDL Cholesterol From Baseline to Week 12	Baseline, week12		Percent Change	LEAST_SQUARES_MEAN
SECONDARY	Percent Change in Non-HDL Cholesterol From Baseline to Week 12	Baseline, week12		Percent Change	LEAST_SQUARES_MEAN
SECONDARY	Percent Change in Total Cholesterol From Baseline to Week 12	Baseline, week12		Percent Change	LEAST_SQUARES_MEAN
SECONDARY	Percent Change in Triglycerides From Baseline to Week 12	Baseline, week12		Percent Change	LEAST_SQUARES_MEAN
SECONDARY	Percent Change in Apolipoprotein B From Baseline to Week 12	Baseline, week12		Percent Change	LEAST_SQUARES_MEAN
SECONDARY	Percent Change in High Sensitivity C Reactive Protein From Baseline to Week 12	Baseline, week12		Percent Change	LEAST_SQUARES_MEAN
SECONDARY	Percent Change in Hemoglobin A1c From Baseline to Week 12	Baseline, week12		Percent Change	LEAST_SQUARES_MEAN
SECONDARY	Proportion of Subjects Whose LDL-C Value Achieved the Lipid Management Goals Based on Risk Assessment at Week 12	Baseline, week12		participants	NUMBER
SECONDARY	Proportion of Subjects Whose LDL-C Value Achieve < 70 mg/dL at Week 12	Baseline, week12		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group40

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Percent Change in LDL-C From Baseline to Week 12	ETC-1002 60 mg	-10.59	Standard Error 2.153	Percent Change
Percent Change in LDL-C From Baseline to Week 12	ETC-1002 120 mg	-21.85	Standard Error 2.156	Percent Change
Percent Change in LDL-C From Baseline to Week 12	ETC-1002 180 mg	-21.26	Standard Error 2.095	Percent Change
Percent Change in LDL-C From Baseline to Week 12	Placebo	-1.92	Standard Error 2.117	Percent Change
Percent Change in HDL Cholesterol From Baseline to Week 12	ETC-1002 60 mg	0.16	Standard Error 2.208	Percent Change
Percent Change in HDL Cholesterol From Baseline to Week 12	ETC-1002 120 mg	-0.65	Standard Error 2.190	Percent Change
Percent Change in HDL Cholesterol From Baseline to Week 12	ETC-1002 180 mg	-7.29	Standard Error 2.139	Percent Change
Percent Change in HDL Cholesterol From Baseline to Week 12	Placebo	3.08	Standard Error 2.155	Percent Change
Percent Change in Non-HDL Cholesterol From Baseline to Week 12	ETC-1002 60 mg	-8.86	Standard Error 2.019	Percent Change
Percent Change in Non-HDL Cholesterol From Baseline to Week 12	ETC-1002 120 mg	-18.29	Standard Error 2.021	Percent Change

1 to 10 of 40Source ClinicalTrials.gov

See all 40 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	ETC-1002 60 mg	47
Overall Study	STARTED	ETC-1002 120 mg	46
Overall Study	STARTED	ETC-1002 180 mg	48
Overall Study	STARTED	Placebo	47
Overall Study	COMPLETED	ETC-1002 60 mg	44
Overall Study	COMPLETED	ETC-1002 120 mg	46
Overall Study	COMPLETED	ETC-1002 180 mg	46
Overall Study	COMPLETED	Placebo	46
Overall Study	NOT COMPLETED	ETC-1002 60 mg	3
Overall Study	NOT COMPLETED	ETC-1002 120 mg	0

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events108

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Abdominal pain upper	Gastrointestinal disorders	ETC-1002 60 mg	4	47
other	Abdominal pain upper	Gastrointestinal disorders	ETC-1002 120 mg	1	46
other	Abdominal pain upper	Gastrointestinal disorders	ETC-1002 180 mg	0	48
other	Abdominal pain upper	Gastrointestinal disorders	Placebo	0	47
other	Diarrhoea	Gastrointestinal disorders	ETC-1002 60 mg	3	47
other	Diarrhoea	Gastrointestinal disorders	ETC-1002 120 mg	1	46
other	Diarrhoea	Gastrointestinal disorders	ETC-1002 180 mg	1	48
other	Diarrhoea	Gastrointestinal disorders	Placebo	1	47
other	Large intestine polyp	Gastrointestinal disorders	ETC-1002 60 mg	0	47
other	Large intestine polyp	Gastrointestinal disorders	ETC-1002 120 mg	2	46

1 to 10 of 108Source ClinicalTrials.gov

See all 108 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	ETC-1002 60 mg	0	47
Total, all-cause mortality	ETC-1002 120 mg	0	46
Total, all-cause mortality	ETC-1002 180 mg	0	47
Total, all-cause mortality	Placebo	0	48
Total, other adverse events	ETC-1002 60 mg	23	47
Total, other adverse events	ETC-1002 120 mg	17	46
Total, other adverse events	ETC-1002 180 mg	21	48
Total, other adverse events	Placebo	9	47
Total, serious adverse events	ETC-1002 60 mg	0	47
Total, serious adverse events	ETC-1002 120 mg	0	46

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04784442

GET https://conductscience.org/api/trials/v1/NCT04784442/results?page=2

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