Assessment of the Long-Term Safety and Efficacy of Bempedoic Acid (CLEAR Harmony OLE)
Sponsor
Esperion Therapeutics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03067441
Collaborator
(none)
1,462
3
1
33
487.3
14.8
Study Details
Study Description
Brief Summary
The purpose of this study is to see if bempedoic acid (ETC-1002) is safe and well-tolerated in patients with high cardiovascular risk and elevated LDL cholesterol that is not adequately controlled by their current therapy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
1462 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multicenter Open-Label Extension (OLE) Study To Assess The Long-Term Safety and Efficacy of Bempedoic Acid (ETC-1002) 180 MG
Actual Study Start Date
:
Feb 3, 2017
Actual Primary Completion Date
:
Nov 5, 2019
Actual Study Completion Date
:
Nov 5, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Open-Label bempedoic acid bempedoic acid 180 mg tablet |
Drug: bempedoic acid
bempedoic acid 180 mg tablets taken orally, once per day.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [Up to Week 82]
TEAEs are defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) Study.
Secondary Outcome Measures
- Percent Change From Parent Study Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Weeks 52 and 78 [Baseline; Week 52 and Week 78]
Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: LDL-C value at Week 52/Week 78 minus Parent Study Baseline value divided by Parent Study Baseline value multiplied by 100. Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1) in the Parent Study.
- Mean Change From Parent Study Baseline in LDL-C at Weeks 52 and 78 [Baseline; Week 52 and Week 78]
Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Mean change from Baseline was calculated as: Mean LDL-C value at Week 52/Week 78 minus Mean Parent Study Baseline value. Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1) in the Parent Study.
- Percent Change From Parent Study Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 52 and 78 [Baseline; Week 52 and Week 72]
Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: non-HDL-C value at Week 52/Week 78 minus Parent Study Baseline value divided by Parent Study Baseline value multiplied by 100. Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1) in the Parent Study.
- Percent Change From Parent Study Baseline in Total Cholesterol at Weeks 52 and 78 [Baseline; Week 52 and Week 78]
Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: Total cholesterol value at Week 52/Week 78 minus Parent Study Baseline value divided by Parent Study Baseline value multiplied by 100. Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1) in the Parent Study.
- Percent Change From Parent Study Baseline in Apolipoprotein B (ApoB) at Weeks 52 and 78 [Baseline; Week 52 and Week 78]
Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: ApoB value at Week 52/Week 78 minus Parent Study Baseline value divided by Parent Study Baseline value multiplied by 100. Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1) in the Parent Study.
- Percent Change From Parent Study Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) at Weeks 52 and 78 [Baseline; Week 52 and Week 78]
Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: hs-CRP value at Week 52/Week 78 minus Parent Study Baseline value divided by Parent Study Baseline value multiplied by 100. Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1) in the Parent Study.
- Percent Change From Parent Study Baseline in Triglycerides at Weeks 52 and 78 [Baseline; Week 52 and Week 78]
Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: Triglycerides value at Week 52/Week 78 minus Parent Study Baseline value divided by Parent Study Baseline value multiplied by 100. Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1) in the Parent Study.
- Percent Change From Parent Study Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Weeks 52 and 78 [Baseline; Week 52 and Week 78]
Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: HDL-C value at Week 52/Week 78 minus Parent Study Baseline value divided by Parent Study Baseline value multiplied by 100. Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1) in the Parent Study.
- Percent Change From Open-Label Extension (OLE) Study Baseline in LDL-C at Weeks 52 and 78 [Baseline; Week 52 and Week 78]
Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: LDL-C value at Week 52/Week 78 minus OLE Study Baseline value divided by Parent Study Baseline value multiplied by 100. Baseline was defined as the last non-missing record prior to treatment start in the OLE Study.
- Mean Change From OLE Baseline in LDL-C at Weeks 52 and 78 [Baseline; Week 52 and Week 72]
Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Mean change from Baseline was calculated as: Mean LDL-C value at Week 52/Week 78 minus Mean OLE Study Baseline value. Baseline was defined as the last non-missing record prior to treatment start in the OLE Study.
- Percent Change From OLE Baseline in Non-HDL-C at Weeks 52 and 78 [Baseline; Week 52 and Week 78]
Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: non-HDL-C value at Week 52/Week 78 minus OLE Study Baseline value divided by OLE Study Baseline value multiplied by 100. Baseline was defined as the last non-missing record prior to treatment start in the OLE Study.
- Percent Change From OLE Baseline in Total Cholesterol at Weeks 52 and 78 [Baseline; Week 52 and Week 78]
Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: Total Cholesterol value at Week 52/Week 78 minus OLE Study Baseline value divided by OLE Study Baseline value multiplied by 100. Baseline was defined as the last non-missing record prior to treatment start in the OLE Study.
- Percent Change From OLE Baseline ApoB at Weeks 52 and 78 [Baseline; Week 52 and Week 78]
Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: ApoB value at Week 52/Week 78 minus OLE Study Baseline value divided by OLE Study Baseline value multiplied by 100. Baseline was defined as the last non-missing record prior to treatment start in the OLE Study.
- Percent Change From OLE Baseline in Hs-CRP at Weeks 52 and 78 [Baseline; Week 52 and Week 78]
Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: hs-CRP value at Week 52/Week 78 minus OLE Study Baseline value divided by OLE Study Baseline value multiplied by 100. Baseline was defined as the last non-missing record prior to treatment start in the OLE Study.
- Percent Change From OLE Baseline in Triglycerides at Weeks 52 and 78 [Baseline; Week 52 and Week 78]
Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: Triglycerides value at Week 52/Week 78 minus OLE Study Baseline value divided by OLE Study Baseline value multiplied by 100. Baseline was defined as the last non-missing record prior to treatment start in the OLE Study.
- Percent Change From OLE Baseline in HDL-C at Weeks 52 and 78 [Baseline; Week 52 and Week 78]
Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: HDL-C value at Week 52/Week 78 minus OLE Study Baseline value divided by OLE Study Baseline value multiplied by 100. Baseline was defined as the last non-missing record prior to treatment start in the OLE Study.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Successfully completed CLEAR Harmony (1002-040) parent study
Exclusion Criteria:
-
Experienced a treatment-related SAE that led to study drug discontinuation in the CLEAR Harmony (1002-040) parent study.
-
Medical condition requires lipid measurement and/or adjustment of background lipid-regulating therapy.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Jedidiah Clinical Research | Tampa | Florida | United States | 33607 |
| 2 | L-MARC Research Center | Louisville | Kentucky | United States | 40213 |
| 3 | Sentral Clinical Research Services | Cincinnati | Ohio | United States | 45236 |
Sponsors and Collaborators
- Esperion Therapeutics, Inc.
Investigators
- Study Director: Medical Director, Esperion Therapeutics, Inc.
Study Documents (Full-Text)
More Information
Additional Information:
- World Health Organization Fact Sheet No. 317
- Familial Hypercholesterolemia Foundation
- National Organization for Rare Disorders - Familial Hypercholesterolemia
- CLEAR Harmony - Reference to the Parent Study (NCT02666664)
Publications
- Goldberg AC, Hopkins PN, Toth PP, Ballantyne CM, Rader DJ, Robinson JG, Daniels SR, Gidding SS, de Ferranti SD, Ito MK, McGowan MP, Moriarty PM, Cromwell WC, Ross JL, Ziajka PE; National Lipid Association Expert Panel on Familial Hypercholesterolemia. Familial hypercholesterolemia: screening, diagnosis and management of pediatric and adult patients: clinical guidance from the National Lipid Association Expert Panel on Familial Hypercholesterolemia. J Clin Lipidol. 2011 Jun;5(3 Suppl):S1-8. doi: 10.1016/j.jacl.2011.04.003. Epub 2011 Apr 12.
- Pinkosky SL, Newton RS, Day EA, Ford RJ, Lhotak S, Austin RC, Birch CM, Smith BK, Filippov S, Groot PHE, Steinberg GR, Lalwani ND. Liver-specific ATP-citrate lyase inhibition by bempedoic acid decreases LDL-C and attenuates atherosclerosis. Nat Commun. 2016 Nov 28;7:13457. doi: 10.1038/ncomms13457.
- Pollex RL, Joy TR, Hegele RA. Emerging antidyslipidemic drugs. Expert Opin Emerg Drugs. 2008 Jun;13(2):363-81. doi: 10.1517/14728214.13.2.363 . Review.
- Sharrett AR, Ballantyne CM, Coady SA, Heiss G, Sorlie PD, Catellier D, Patsch W; Atherosclerosis Risk in Communities Study Group. Coronary heart disease prediction from lipoprotein cholesterol levels, triglycerides, lipoprotein(a), apolipoproteins A-I and B, and HDL density subfractions: The Atherosclerosis Risk in Communities (ARIC) Study. Circulation. 2001 Sep 4;104(10):1108-13.
- Stone NJ, Robinson JG, Lichtenstein AH, Bairey Merz CN, Blum CB, Eckel RH, Goldberg AC, Gordon D, Levy D, Lloyd-Jones DM, McBride P, Schwartz JS, Shero ST, Smith SC Jr, Watson K, Wilson PW, Eddleman KM, Jarrett NM, LaBresh K, Nevo L, Wnek J, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Smith SC Jr, Tomaselli GF; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Jun 24;129(25 Suppl 2):S1-45. doi: 10.1161/01.cir.0000437738.63853.7a. Epub 2013 Nov 12. Erratum in: Circulation. 2014 Jun 24;129(25 Suppl 2):S46-8. Erratum in: Circulation. 2015 Dec 22;132(25):e396.
Responsible Party:
Esperion Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT03067441
Other Study ID Numbers:
- 1002-050
- 2016-004115-12
First Posted:
Mar 1, 2017
Last Update Posted:
Mar 1, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Esperion Therapeutics, Inc.
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | After successfully completing 52 weeks of treatment in the parent study, Study 1002-040 (NCT02666664), and meeting entry criteria, participants could enrol into this Open-label Extension (OLE) study. |
| Arm/Group Title | Placebo; Bempedoic Acid | Bempedoic Acid; Bempedoic Acid |
|---|---|---|
| Arm/Group Description | In the parent study (Study 1002-040), participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 milligrams (mg) once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of investigational medicinal product (IMP). | In the parent study, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP. |
| Period Title: Overall Study | ||
| STARTED | 492 | 970 |
| COMPLETED | 459 | 913 |
| NOT COMPLETED | 33 | 57 |
Baseline Characteristics
| Arm/Group Title | Placebo; Bempedoic Acid | Bempedoic Acid; Bempedoic Acid | Total |
|---|---|---|---|
| Arm/Group Description | In the parent study (Study 1002-040), participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 milligrams (mg) once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of investigational medicinal product (IMP). | In the parent study, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP. | Total of all reporting groups |
| Overall Participants | 492 | 970 | 1462 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
67.5
(8.54)
|
66.5
(8.81)
|
66.9
(8.73)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
142
28.9%
|
239
24.6%
|
381
26.1%
|
| Male |
350
71.1%
|
731
75.4%
|
1081
73.9%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
2
0.2%
|
2
0.1%
|
| Asian |
5
1%
|
9
0.9%
|
14
1%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
1
0.1%
|
1
0.1%
|
| Black or African American |
6
1.2%
|
23
2.4%
|
29
2%
|
| White |
480
97.6%
|
931
96%
|
1411
96.5%
|
| More than one race |
0
0%
|
1
0.1%
|
1
0.1%
|
| Unknown or Not Reported |
1
0.2%
|
3
0.3%
|
4
0.3%
|
| Low-density lipoprotein cholesterol (LDL-C): Parent Study (milligrams per deciliter (mg/dL)) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [milligrams per deciliter (mg/dL)] |
98.96
(24.171)
|
102.94
(29.899)
|
101.60
(28.156)
|
| Non-high-density lipoprotein cholesterol (N-HDL-C): Parent Study (mg/dL) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [mg/dL] |
126.41
(28.531)
|
130.09
(34.727)
|
128.85
(32.809)
|
| Total cholesterol: Parent Study (mg/dL) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [mg/dL] |
175.33
(30.026)
|
178.94
(36.057)
|
177.73
(34.179)
|
| Apolipoprotein B: Parent Study (mg/dL) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [mg/dL] |
85.1
(19.25)
|
88.2
(21.71)
|
87.2
(20.97)
|
| High-sensitivity C-reactive protein (hs-CRP): Parent Study (milligrams per Liter (mg/L)) [Median (Inter-Quartile Range) ] | |||
| Median (Inter-Quartile Range) [milligrams per Liter (mg/L)] |
1.515
|
1.500
|
1.510
|
| Triglycerides: Parent Study (mg/dL) [Median (Inter-Quartile Range) ] | |||
| Median (Inter-Quartile Range) [mg/dL] |
122.00
|
125.00
|
124.00
|
| High-density lipoprotein cholesterol (HDL-C): Parent Study (mg/dL) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [mg/dL] |
48.93
(11.206)
|
48.82
(11.790)
|
48.86
(11.593)
|
| LDL-C: OLE Study (mg/dL) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [mg/dL] |
99.5
(28.59)
|
86.6
(30.18)
|
91.0
(30.26)
|
| N-HDL-C: OLE Study (mg/dL) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [mg/dL] |
126.1
(32.61)
|
113.7
(34.57)
|
117.9
(34.42)
|
| Total cholesterol: OLE Study (mg/dL) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [mg/dL] |
175.2
(34.23)
|
159.8
(36.41)
|
165.0
(36.41)
|
| Apolipoprotein B: OLE Study (mg/dL) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [mg/dL] |
87.6
(22.74)
|
80.4
(21.31)
|
82.8
(22.07)
|
| hs-CRP: OLE Study (mg/L) [Median (Inter-Quartile Range) ] | |||
| Median (Inter-Quartile Range) [mg/L] |
1.560
|
1.250
|
1.325
|
| Triglycerides: OLE Study (mg/dL) [Median (Inter-Quartile Range) ] | |||
| Median (Inter-Quartile Range) [mg/dL] |
120.0
|
121.0
|
120.0
|
| HDL-C: OLE Study (mg/dL) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [mg/dL] |
49.0
(11.72)
|
46.1
(13.00)
|
47.1
(12.66)
|
Outcome Measures
| Title | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
|---|---|
| Description | TEAEs are defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) Study. |
| Time Frame | Up to Week 82 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population: all enrolled participants who received at least 1 dose of bempedoic acid in the OLE Study |
| Arm/Group Title | Placebo; Bempedoic Acid | Bempedoic Acid; Bempedoic Acid | OLE Bempedoic Acid |
|---|---|---|---|
| Arm/Group Description | In the parent study (Study 1002-040), participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 milligrams (mg) once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of investigational medicinal product (IMP). | In the parent study, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP. | In the parent study, participants received either bempedoic acid 180 mg tablet or matching placebo, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP. |
| Measure Participants | 492 | 970 | 1462 |
| Participants with TEAEs |
385
78.3%
|
758
78.1%
|
1143
78.2%
|
| Participants with serious TEAEs |
97
19.7%
|
202
20.8%
|
299
20.5%
|
| Participants with TEAEs of mild severity |
93
18.9%
|
195
20.1%
|
288
19.7%
|
| Participants with TEAEs of moderate severity |
211
42.9%
|
403
41.5%
|
614
42%
|
| Participants with TEAEs of severe severity |
81
16.5%
|
160
16.5%
|
241
16.5%
|
| Title | Percent Change From Parent Study Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Weeks 52 and 78 |
|---|---|
| Description | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: LDL-C value at Week 52/Week 78 minus Parent Study Baseline value divided by Parent Study Baseline value multiplied by 100. Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1) in the Parent Study. |
| Time Frame | Baseline; Week 52 and Week 78 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population. Only participants with available data were analyzed. |
| Arm/Group Title | Placebo; Bempedoic Acid | Bempedoic Acid; Bempedoic Acid | OLE Bempedoic Acid |
|---|---|---|---|
| Arm/Group Description | In the parent study (Study 1002-040), participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 milligrams (mg) once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP. | In the parent study, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP. | In the parent study, participants received either bempedoic acid 180 mg tablet or matching placebo, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP. |
| Measure Participants | 492 | 970 | 1462 |
| Week 52 |
-12.82
(23.419)
|
-13.80
(25.018)
|
-13.47
(24.485)
|
| Week 78 |
-14.99
(23.660)
|
-14.15
(25.113)
|
-14.43
(24.632)
|
| Title | Mean Change From Parent Study Baseline in LDL-C at Weeks 52 and 78 |
|---|---|
| Description | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Mean change from Baseline was calculated as: Mean LDL-C value at Week 52/Week 78 minus Mean Parent Study Baseline value. Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1) in the Parent Study. |
| Time Frame | Baseline; Week 52 and Week 78 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population. Only participants with available data were analyzed. |
| Arm/Group Title | Placebo; Bempedoic Acid | Bempedoic Acid; Bempedoic Acid | OLE Bempedoic Acid |
|---|---|---|---|
| Arm/Group Description | In the parent study (Study 1002-040), participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 milligrams (mg) once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP. | In the parent study, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP. | In the parent study, participants received either bempedoic acid 180 mg tablet or matching placebo, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP. |
| Measure Participants | 492 | 970 | 1462 |
| Week 52 |
-14.08
(24.995)
|
-15.77
(28.123)
|
-15.19
(27.109)
|
| Week 78 |
-16.11
(25.628)
|
-16.04
(28.929)
|
-16.06
(27.862)
|
| Title | Percent Change From Parent Study Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 52 and 78 |
|---|---|
| Description | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: non-HDL-C value at Week 52/Week 78 minus Parent Study Baseline value divided by Parent Study Baseline value multiplied by 100. Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1) in the Parent Study. |
| Time Frame | Baseline; Week 52 and Week 72 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population. Only participants with available data were analyzed. |
| Arm/Group Title | Placebo; Bempedoic Acid | Bempedoic Acid; Bempedoic Acid | OLE Bempedoic Acid |
|---|---|---|---|
| Arm/Group Description | In the parent study (Study 1002-040), participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 milligrams (mg) once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP. | In the parent study, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP. | In the parent study, participants received either bempedoic acid 180 mg tablet or matching placebo, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP. |
| Measure Participants | 492 | 970 | 1462 |
| Week 52 |
-10.60
(20.722)
|
-10.55
(22.682)
|
-10.57
(22.033)
|
| Week 78 |
-12.50
(22.081)
|
-10.82
(23.910)
|
-11.38
(23.321)
|
| Title | Percent Change From Parent Study Baseline in Total Cholesterol at Weeks 52 and 78 |
|---|---|
| Description | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: Total cholesterol value at Week 52/Week 78 minus Parent Study Baseline value divided by Parent Study Baseline value multiplied by 100. Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1) in the Parent Study. |
| Time Frame | Baseline; Week 52 and Week 78 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population. Only participants with available data were analyzed. |
| Arm/Group Title | Placebo; Bempedoic Acid | Bempedoic Acid; Bempedoic Acid | OLE Bempedoic Acid |
|---|---|---|---|
| Arm/Group Description | In the parent study (Study 1002-040), participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 milligrams (mg) once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP. | In the parent study, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP. | In the parent study, participants received either bempedoic acid 180 mg tablet or matching placebo, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP. |
| Measure Participants | 492 | 970 | 1462 |
| Week 52 |
-9.01
(15.961)
|
-9.79
(16.893)
|
-9.53
(16.582)
|
| Week 78 |
-10.15
(16.541)
|
-9.34
(18.030)
|
-9.61
(17.545)
|
| Title | Percent Change From Parent Study Baseline in Apolipoprotein B (ApoB) at Weeks 52 and 78 |
|---|---|
| Description | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: ApoB value at Week 52/Week 78 minus Parent Study Baseline value divided by Parent Study Baseline value multiplied by 100. Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1) in the Parent Study. |
| Time Frame | Baseline; Week 52 and Week 78 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population. Only participants with available data were analyzed. |
| Arm/Group Title | Placebo; Bempedoic Acid | Bempedoic Acid; Bempedoic Acid | OLE Bempedoic Acid |
|---|---|---|---|
| Arm/Group Description | In the parent study (Study 1002-040), participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 milligrams (mg) once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP. | In the parent study, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP. | In the parent study, participants received either bempedoic acid 180 mg tablet or matching placebo, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP. |
| Measure Participants | 492 | 970 | 1462 |
| Week 52 |
-7.5
(20.52)
|
-8.8
(21.89)
|
-8.4
(21.44)
|
| Week 78 |
-7.6
(22.15)
|
-7.0
(22.33)
|
-7.2
(22.26)
|
| Title | Percent Change From Parent Study Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) at Weeks 52 and 78 |
|---|---|
| Description | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: hs-CRP value at Week 52/Week 78 minus Parent Study Baseline value divided by Parent Study Baseline value multiplied by 100. Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1) in the Parent Study. |
| Time Frame | Baseline; Week 52 and Week 78 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population. Only participants with available data were analyzed. |
| Arm/Group Title | Placebo; Bempedoic Acid | Bempedoic Acid; Bempedoic Acid | OLE Bempedoic Acid |
|---|---|---|---|
| Arm/Group Description | In the parent study (Study 1002-040), participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 milligrams (mg) once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP. | In the parent study, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP. | In the parent study, participants received either bempedoic acid 180 mg tablet or matching placebo, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP. |
| Measure Participants | 492 | 970 | 1462 |
| Week 52 |
-11.553
|
-19.709
|
-16.476
|
| Week 78 |
-15.005
|
-18.065
|
-16.740
|
| Title | Percent Change From Parent Study Baseline in Triglycerides at Weeks 52 and 78 |
|---|---|
| Description | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: Triglycerides value at Week 52/Week 78 minus Parent Study Baseline value divided by Parent Study Baseline value multiplied by 100. Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1) in the Parent Study. |
| Time Frame | Baseline; Week 52 and Week 78 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population. Only participants with available data were analyzed. |
| Arm/Group Title | Placebo; Bempedoic Acid | Bempedoic Acid; Bempedoic Acid | OLE Bempedoic Acid |
|---|---|---|---|
| Arm/Group Description | In the parent study (Study 1002-040), participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 milligrams (mg) once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP. | In the parent study, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP. | In the parent study, participants received either bempedoic acid 180 mg tablet or matching placebo, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP. |
| Measure Participants | 492 | 970 | 1462 |
| Week 52 |
-4.31
|
-3.21
|
-3.49
|
| Week 78 |
-5.00
|
-2.60
|
-3.08
|
| Title | Percent Change From Parent Study Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Weeks 52 and 78 |
|---|---|
| Description | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: HDL-C value at Week 52/Week 78 minus Parent Study Baseline value divided by Parent Study Baseline value multiplied by 100. Baseline was defined as the mean of the values at screening and predose Day 1/Week 0 (Visit T1) in the Parent Study. |
| Time Frame | Baseline; Week 52 and Week 78 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population. Only participants with available data were analyzed. |
| Arm/Group Title | Placebo; Bempedoic Acid | Bempedoic Acid; Bempedoic Acid | OLE Bempedoic Acid |
|---|---|---|---|
| Arm/Group Description | In the parent study (Study 1002-040), participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 milligrams (mg) once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP. | In the parent study, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP. | In the parent study, participants received either bempedoic acid 180 mg tablet or matching placebo, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP. |
| Measure Participants | 492 | 970 | 1462 |
| Week 52 |
-4.54
(16.747)
|
-7.06
(15.638)
|
-6.20
(16.060)
|
| Week 78 |
-3.42
(17.555)
|
-4.91
(16.731)
|
-4.41
(17.018)
|
| Title | Percent Change From Open-Label Extension (OLE) Study Baseline in LDL-C at Weeks 52 and 78 |
|---|---|
| Description | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: LDL-C value at Week 52/Week 78 minus OLE Study Baseline value divided by Parent Study Baseline value multiplied by 100. Baseline was defined as the last non-missing record prior to treatment start in the OLE Study. |
| Time Frame | Baseline; Week 52 and Week 78 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population. Only participants with available data were analyzed. |
| Arm/Group Title | Placebo; Bempedoic Acid | Bempedoic Acid; Bempedoic Acid | OLE Bempedoic Acid |
|---|---|---|---|
| Arm/Group Description | In the parent study (Study 1002-040), participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 milligrams (mg) once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP. | In the parent study, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP. | In the parent study, participants received either bempedoic acid 180 mg tablet or matching placebo, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP. |
| Measure Participants | 492 | 970 | 1462 |
| Week 52 |
-12.4
(23.79)
|
3.6
(27.49)
|
-1.8
(27.35)
|
| Week 78 |
-14.3
(25.79)
|
3.7
(30.63)
|
-2.3
(30.31)
|
| Title | Mean Change From OLE Baseline in LDL-C at Weeks 52 and 78 |
|---|---|
| Description | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Mean change from Baseline was calculated as: Mean LDL-C value at Week 52/Week 78 minus Mean OLE Study Baseline value. Baseline was defined as the last non-missing record prior to treatment start in the OLE Study. |
| Time Frame | Baseline; Week 52 and Week 72 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population. Only participants with available data were analyzed. |
| Arm/Group Title | Placebo; Bempedoic Acid | Bempedoic Acid; Bempedoic Acid | OLE Bempedoic Acid |
|---|---|---|---|
| Arm/Group Description | In the parent study (Study 1002-040), participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 milligrams (mg) once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP. | In the parent study, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP. | In the parent study, participants received either bempedoic acid 180 mg tablet or matching placebo, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP. |
| Measure Participants | 492 | 970 | 1462 |
| Week 52 |
-14.7
(25.63)
|
0.6
(24.92)
|
-4.6
(26.17)
|
| Week 78 |
-17.0
(28.56)
|
0.2
(26.04)
|
-5.5
(28.08)
|
| Title | Percent Change From OLE Baseline in Non-HDL-C at Weeks 52 and 78 |
|---|---|
| Description | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: non-HDL-C value at Week 52/Week 78 minus OLE Study Baseline value divided by OLE Study Baseline value multiplied by 100. Baseline was defined as the last non-missing record prior to treatment start in the OLE Study. |
| Time Frame | Baseline; Week 52 and Week 78 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population. Only participants with available data were analyzed. |
| Arm/Group Title | Placebo; Bempedoic Acid | Bempedoic Acid; Bempedoic Acid | OLE Bempedoic Acid |
|---|---|---|---|
| Arm/Group Description | In the parent study (Study 1002-040), participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 milligrams (mg) once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP. | In the parent study, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP. | In the parent study, participants received either bempedoic acid 180 mg tablet or matching placebo, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP. |
| Measure Participants | 492 | 970 | 1462 |
| Week 52 |
-10.0
(20.81)
|
2.9
(23.98)
|
-1.4
(23.75)
|
| Week 78 |
-11.8
(23.08)
|
3.1
(28.02)
|
-1.9
(27.38)
|
| Title | Percent Change From OLE Baseline in Total Cholesterol at Weeks 52 and 78 |
|---|---|
| Description | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: Total Cholesterol value at Week 52/Week 78 minus OLE Study Baseline value divided by OLE Study Baseline value multiplied by 100. Baseline was defined as the last non-missing record prior to treatment start in the OLE Study. |
| Time Frame | Baseline; Week 52 and Week 78 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population. Only participants with available data were analyzed. |
| Arm/Group Title | Placebo; Bempedoic Acid | Bempedoic Acid; Bempedoic Acid | OLE Bempedoic Acid |
|---|---|---|---|
| Arm/Group Description | In the parent study (Study 1002-040), participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 milligrams (mg) once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP. | In the parent study, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP. | In the parent study, participants received either bempedoic acid 180 mg tablet or matching placebo, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP. |
| Measure Participants | 492 | 970 | 1462 |
| Week 52 |
-8.7
(15.78)
|
1.3
(17.23)
|
-2.1
(17.40)
|
| Week 78 |
-9.7
(17.39)
|
2.1
(19.88)
|
-1.8
(19.88)
|
| Title | Percent Change From OLE Baseline ApoB at Weeks 52 and 78 |
|---|---|
| Description | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: ApoB value at Week 52/Week 78 minus OLE Study Baseline value divided by OLE Study Baseline value multiplied by 100. Baseline was defined as the last non-missing record prior to treatment start in the OLE Study. |
| Time Frame | Baseline; Week 52 and Week 78 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population. Only participants with available data were analyzed. |
| Arm/Group Title | Placebo; Bempedoic Acid | Bempedoic Acid; Bempedoic Acid | OLE Bempedoic Acid |
|---|---|---|---|
| Arm/Group Description | In the parent study (Study 1002-040), participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 milligrams (mg) once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP. | In the parent study, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP. | In the parent study, participants received either bempedoic acid 180 mg tablet or matching placebo, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP. |
| Measure Participants | 492 | 970 | 1462 |
| Week 52 |
-10.0
(19.94)
|
0.2
(21.48)
|
-3.2
(21.51)
|
| Week 78 |
-10.2
(21.84)
|
2.4
(23.16)
|
-1.8
(23.49)
|
| Title | Percent Change From OLE Baseline in Hs-CRP at Weeks 52 and 78 |
|---|---|
| Description | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: hs-CRP value at Week 52/Week 78 minus OLE Study Baseline value divided by OLE Study Baseline value multiplied by 100. Baseline was defined as the last non-missing record prior to treatment start in the OLE Study. |
| Time Frame | Baseline; Week 52 and Week 78 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population. Only participants with available data were analyzed. |
| Arm/Group Title | Placebo; Bempedoic Acid | Bempedoic Acid; Bempedoic Acid | OLE Bempedoic Acid |
|---|---|---|---|
| Arm/Group Description | In the parent study (Study 1002-040), participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 milligrams (mg) once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP. | In the parent study, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP. | In the parent study, participants received either bempedoic acid 180 mg tablet or matching placebo, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP. |
| Measure Participants | 492 | 970 | 1462 |
| Week 52 |
-11.720
|
-2.174
|
-4.856
|
| Week 78 |
-14.953
|
3.774
|
-2.538
|
| Title | Percent Change From OLE Baseline in Triglycerides at Weeks 52 and 78 |
|---|---|
| Description | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: Triglycerides value at Week 52/Week 78 minus OLE Study Baseline value divided by OLE Study Baseline value multiplied by 100. Baseline was defined as the last non-missing record prior to treatment start in the OLE Study. |
| Time Frame | Baseline; Week 52 and Week 78 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population. Only participants with available data were analyzed. |
| Arm/Group Title | Placebo; Bempedoic Acid | Bempedoic Acid; Bempedoic Acid | OLE Bempedoic Acid |
|---|---|---|---|
| Arm/Group Description | In the parent study (Study 1002-040), participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 milligrams (mg) once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP. | In the parent study, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP. | In the parent study, participants received either bempedoic acid 180 mg tablet or matching placebo, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP. |
| Measure Participants | 492 | 970 | 1462 |
| Week 52 |
0.3
|
0.9
|
0.7
|
| Week 78 |
-2.0
|
2.2
|
0.9
|
| Title | Percent Change From OLE Baseline in HDL-C at Weeks 52 and 78 |
|---|---|
| Description | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Percent change from Baseline was calculated as: HDL-C value at Week 52/Week 78 minus OLE Study Baseline value divided by OLE Study Baseline value multiplied by 100. Baseline was defined as the last non-missing record prior to treatment start in the OLE Study. |
| Time Frame | Baseline; Week 52 and Week 78 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population. Only participants with available data were analyzed. |
| Arm/Group Title | Placebo; Bempedoic Acid | Bempedoic Acid; Bempedoic Acid | OLE Bempedoic Acid |
|---|---|---|---|
| Arm/Group Description | In the parent study (Study 1002-040), participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 milligrams (mg) once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP. | In the parent study, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP. | In the parent study, participants received either bempedoic acid 180 mg tablet or matching placebo, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP. |
| Measure Participants | 492 | 970 | 1462 |
| Week 52 |
-4.3
(18.36)
|
-0.6
(14.88)
|
-1.8
(16.23)
|
| Week 78 |
-3.4
(17.77)
|
2.7
(23.60)
|
0.7
(22.01)
|
Adverse Events
| Time Frame | Up to Week 82 | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Treatment-emergent adverse events, defined as adverse events that began or worsened in severity after the first dose of investigational medicinal product (IMP) until 30 days after the last dose in the Open-Label Extension (OLE) study, are reported. | |||||
| Arm/Group Title | Placebo; Bempedoic Acid | Bempedoic Acid; Bempedoic Acid | OLE Bempedoic Acid | |||
| Arm/Group Description | In the parent study (Study 1002-040), participants received placebo tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 milligrams (mg) once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of investigational medicinal product (IMP). | In the parent study, participants received bempedoic acid 180 mg tablet, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP. | In the parent study, participants received either bempedoic acid 180 mg tablet or matching placebo, once daily by mouth for 52 weeks. In addition, participants received stable background lipid-modifying therapy(ies), including a maximally tolerated statin, throughout the study. Participants received open-label bempedoic acid 180 mg once daily by mouth for up to 78 weeks after rolling over from the parent study, followed by a 4-week period off of IMP. | |||
All Cause Mortality |
||||||
| Placebo; Bempedoic Acid | Bempedoic Acid; Bempedoic Acid | OLE Bempedoic Acid | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/492 (0.6%) | 10/970 (1%) | 13/1462 (0.9%) | |||
Serious Adverse Events |
||||||
| Placebo; Bempedoic Acid | Bempedoic Acid; Bempedoic Acid | OLE Bempedoic Acid | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 97/492 (19.7%) | 202/970 (20.8%) | 299/1462 (20.5%) | |||
| Blood and lymphatic system disorders | ||||||
| Anaemia | 2/492 (0.4%) | 1/970 (0.1%) | 3/1462 (0.2%) | |||
| Abdominal lymphadenopathy | 1/492 (0.2%) | 0/970 (0%) | 1/1462 (0.1%) | |||
| Coagulopathy | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Pancytopenia | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Splenic haematoma | 1/492 (0.2%) | 0/970 (0%) | 1/1462 (0.1%) | |||
| Cardiac disorders | ||||||
| Coronary artery disease | 3/492 (0.6%) | 15/970 (1.5%) | 18/1462 (1.2%) | |||
| Angina pectoris | 5/492 (1%) | 9/970 (0.9%) | 14/1462 (1%) | |||
| Atrial fibrillation | 2/492 (0.4%) | 12/970 (1.2%) | 14/1462 (1%) | |||
| Angina unstable | 3/492 (0.6%) | 10/970 (1%) | 13/1462 (0.9%) | |||
| Acute myocardial infarction | 2/492 (0.4%) | 7/970 (0.7%) | 9/1462 (0.6%) | |||
| Myocardial ischaemia | 3/492 (0.6%) | 6/970 (0.6%) | 9/1462 (0.6%) | |||
| Myocardial infarction | 2/492 (0.4%) | 6/970 (0.6%) | 8/1462 (0.5%) | |||
| Cardiac failure | 0/492 (0%) | 5/970 (0.5%) | 5/1462 (0.3%) | |||
| Cardiac failure congestive | 3/492 (0.6%) | 2/970 (0.2%) | 5/1462 (0.3%) | |||
| Coronary artery stenosis | 0/492 (0%) | 4/970 (0.4%) | 4/1462 (0.3%) | |||
| Cardiac failure chronic | 0/492 (0%) | 3/970 (0.3%) | 3/1462 (0.2%) | |||
| Ventricular tachyarrhythmia | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Ventricular tachycardia | 1/492 (0.2%) | 0/970 (0%) | 1/1462 (0.1%) | |||
| Acute coronary syndrome | 1/492 (0.2%) | 1/970 (0.1%) | 2/1462 (0.1%) | |||
| Acute left ventricular failure | 2/492 (0.4%) | 0/970 (0%) | 2/1462 (0.1%) | |||
| Anginal equivalent | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Atrial flutter | 1/492 (0.2%) | 1/970 (0.1%) | 2/1462 (0.1%) | |||
| Atrioventricular block complete | 1/492 (0.2%) | 1/970 (0.1%) | 2/1462 (0.1%) | |||
| Supraventricular tachycardia | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Cardiac failure acute | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Ischaemic cardiomyopathy | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Left ventricular dysfunction | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Congenital, familial and genetic disorders | ||||||
| Multiple endocrine neoplasia Type 1 | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Endocrine disorders | ||||||
| Adrenal cyst | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Hyperparathyroidism primary | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Eye disorders | ||||||
| Cataract | 1/492 (0.2%) | 6/970 (0.6%) | 7/1462 (0.5%) | |||
| Retinal artery occlusion | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Visual impairment | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Gastrointestinal disorders | ||||||
| Inguinal hernia | 4/492 (0.8%) | 1/970 (0.1%) | 5/1462 (0.3%) | |||
| Pancreatitis acute | 2/492 (0.4%) | 1/970 (0.1%) | 3/1462 (0.2%) | |||
| Gastrointestinal haemorrhage | 1/492 (0.2%) | 1/970 (0.1%) | 2/1462 (0.1%) | |||
| Lower gastrointestinal haemorrhage | 0/492 (0%) | 2/970 (0.2%) | 2/1462 (0.1%) | |||
| Pancreatitis | 1/492 (0.2%) | 1/970 (0.1%) | 2/1462 (0.1%) | |||
| Upper gastrointestinal haemorrhage | 0/492 (0%) | 2/970 (0.2%) | 2/1462 (0.1%) | |||
| Abdominal pain | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Abdominal pain lower | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Abdominal pain upper | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Diverticulum intestinal | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Gastric ulcer haemorrhage | 1/492 (0.2%) | 0/970 (0%) | 1/1462 (0.1%) | |||
| Gastritis | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Hiatus hernia | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Large intestinal ulcer | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Large intestine polyp | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Melaena | 1/492 (0.2%) | 0/970 (0%) | 1/1462 (0.1%) | |||
| Peptic ulcer | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Rectal polyp | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Small intestinal obstruction | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Umbilical hernia | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| General disorders | ||||||
| Non-cardiac chest pain | 1/492 (0.2%) | 8/970 (0.8%) | 9/1462 (0.6%) | |||
| Chest pain | 1/492 (0.2%) | 4/970 (0.4%) | 5/1462 (0.3%) | |||
| Death | 0/492 (0%) | 2/970 (0.2%) | 2/1462 (0.1%) | |||
| Accidental death | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Brain death | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Chest discomfort | 1/492 (0.2%) | 0/970 (0%) | 1/1462 (0.1%) | |||
| Hernia | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Pyrexia | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Vascular stent occlusion | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Vascular stent thrombosis | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Hepatobiliary disorders | ||||||
| Cholelithiasis | 1/492 (0.2%) | 3/970 (0.3%) | 4/1462 (0.3%) | |||
| Cholecystitis acute | 1/492 (0.2%) | 2/970 (0.2%) | 3/1462 (0.2%) | |||
| Hepatitis acute | 1/492 (0.2%) | 0/970 (0%) | 1/1462 (0.1%) | |||
| Infections and infestations | ||||||
| Pneumonia | 6/492 (1.2%) | 9/970 (0.9%) | 15/1462 (1%) | |||
| Sepsis | 2/492 (0.4%) | 4/970 (0.4%) | 6/1462 (0.4%) | |||
| Cellulitis | 0/492 (0%) | 2/970 (0.2%) | 2/1462 (0.1%) | |||
| Gastroenteritis | 0/492 (0%) | 2/970 (0.2%) | 2/1462 (0.1%) | |||
| Influenza | 0/492 (0%) | 2/970 (0.2%) | 2/1462 (0.1%) | |||
| Lower respiratory tract infection | 2/492 (0.4%) | 0/970 (0%) | 2/1462 (0.1%) | |||
| Urinary tract infection | 0/492 (0%) | 2/970 (0.2%) | 2/1462 (0.1%) | |||
| Appendicitis | 1/492 (0.2%) | 0/970 (0%) | 1/1462 (0.1%) | |||
| Appendicitis perforated | 1/492 (0.2%) | 0/970 (0%) | 1/1462 (0.1%) | |||
| Arthritis infective | 1/492 (0.2%) | 0/970 (0%) | 1/1462 (0.1%) | |||
| Bronchitis | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Cystitis | 1/492 (0.2%) | 0/970 (0%) | 1/1462 (0.1%) | |||
| Diverticulitis | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Epididymitis | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Erysipelas | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Gastrointestinal infection | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Intervertebral discitis | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Lymph node tuberculosis | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Meningitis viral | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Ophthalmic herpes zoster | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Pneumonia legionella | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Pulmonary tuberculosis | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Streptococcal bacteraemia | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Urosepsis | 1/492 (0.2%) | 0/970 (0%) | 1/1462 (0.1%) | |||
| Injury, poisoning and procedural complications | ||||||
| Fall | 1/492 (0.2%) | 1/970 (0.1%) | 2/1462 (0.1%) | |||
| Femoral neck fracture | 1/492 (0.2%) | 1/970 (0.1%) | 2/1462 (0.1%) | |||
| Intestinal anastomosis complication | 1/492 (0.2%) | 1/970 (0.1%) | 2/1462 (0.1%) | |||
| Meniscus injury | 1/492 (0.2%) | 1/970 (0.1%) | 2/1462 (0.1%) | |||
| Vascular graft occlusion | 1/492 (0.2%) | 1/970 (0.1%) | 2/1462 (0.1%) | |||
| Ankle fracture | 1/492 (0.2%) | 0/970 (0%) | 1/1462 (0.1%) | |||
| Craniocerebral injury | 1/492 (0.2%) | 0/970 (0%) | 1/1462 (0.1%) | |||
| Femur fracture | 1/492 (0.2%) | 0/970 (0%) | 1/1462 (0.1%) | |||
| Hip fracture | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Incisional hernia | 1/492 (0.2%) | 0/970 (0%) | 1/1462 (0.1%) | |||
| Ligament sprain | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Peripheral artery restenosis | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Periprocedural myocardial infarction | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Procedural pain | 1/492 (0.2%) | 0/970 (0%) | 1/1462 (0.1%) | |||
| Skull fracture | 1/492 (0.2%) | 0/970 (0%) | 1/1462 (0.1%) | |||
| Subarachnoid haemorrhage | 1/492 (0.2%) | 0/970 (0%) | 1/1462 (0.1%) | |||
| Tendon rupture | 1/492 (0.2%) | 0/970 (0%) | 1/1462 (0.1%) | |||
| Upper limb fracture | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Vascular pseudoaneurysm | 1/492 (0.2%) | 0/970 (0%) | 1/1462 (0.1%) | |||
| Investigations | ||||||
| Blood creatinine increased | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Blood pressure decreased | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Haemoglobin decreased | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Stress echocardiogram abnormal | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Transaminases increased | 1/492 (0.2%) | 0/970 (0%) | 1/1462 (0.1%) | |||
| Troponin increased | 1/492 (0.2%) | 0/970 (0%) | 1/1462 (0.1%) | |||
| Ultrasound ovary abnormal | 1/492 (0.2%) | 0/970 (0%) | 1/1462 (0.1%) | |||
| Metabolism and nutrition disorders | ||||||
| Dehydration | 2/492 (0.4%) | 1/970 (0.1%) | 3/1462 (0.2%) | |||
| Diabetic ketoacidosis | 1/492 (0.2%) | 0/970 (0%) | 1/1462 (0.1%) | |||
| Hyperkalaemia | 1/492 (0.2%) | 0/970 (0%) | 1/1462 (0.1%) | |||
| Hypoglycaemia | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Hypokalaemia | 1/492 (0.2%) | 0/970 (0%) | 1/1462 (0.1%) | |||
| Type 2 diabetes mellitus | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Osteoarthritis | 4/492 (0.8%) | 6/970 (0.6%) | 10/1462 (0.7%) | |||
| Arthralgia | 2/492 (0.4%) | 2/970 (0.2%) | 4/1462 (0.3%) | |||
| Back pain | 1/492 (0.2%) | 3/970 (0.3%) | 4/1462 (0.3%) | |||
| Lumbar spinal stenosis | 1/492 (0.2%) | 1/970 (0.1%) | 2/1462 (0.1%) | |||
| Musculoskeletal chest pain | 2/492 (0.4%) | 0/970 (0%) | 2/1462 (0.1%) | |||
| Rotator cuff syndrome | 0/492 (0%) | 2/970 (0.2%) | 2/1462 (0.1%) | |||
| Compartment syndrome | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Intervertebral disc degeneration | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Intervertebral disc protrusion | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Pain in extremity | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Polymyalgia rheumatica | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Pseudarthrosis | 1/492 (0.2%) | 0/970 (0%) | 1/1462 (0.1%) | |||
| Spinal column stenosis | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Bladder cancer | 2/492 (0.4%) | 2/970 (0.2%) | 4/1462 (0.3%) | |||
| Adenocarcinoma of colon | 0/492 (0%) | 2/970 (0.2%) | 2/1462 (0.1%) | |||
| B-cell lymphoma | 1/492 (0.2%) | 1/970 (0.1%) | 2/1462 (0.1%) | |||
| Basal cell carcinoma | 0/492 (0%) | 2/970 (0.2%) | 2/1462 (0.1%) | |||
| Lung neoplasm malignant | 1/492 (0.2%) | 1/970 (0.1%) | 2/1462 (0.1%) | |||
| Malignant melanoma | 1/492 (0.2%) | 1/970 (0.1%) | 2/1462 (0.1%) | |||
| Pancreatic carcinoma | 2/492 (0.4%) | 0/970 (0%) | 2/1462 (0.1%) | |||
| Prostate cancer | 0/492 (0%) | 2/970 (0.2%) | 2/1462 (0.1%) | |||
| Adenocarcinoma | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Bladder transitional cell carcinoma | 1/492 (0.2%) | 0/970 (0%) | 1/1462 (0.1%) | |||
| Clear cell renal cell carcinoma | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Colorectal cancer | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Extranodal marginal zone B-cell lymphoma (MALT type) | 1/492 (0.2%) | 0/970 (0%) | 1/1462 (0.1%) | |||
| Hypergammaglobulinaemia benign monoclonal | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Lung adenocarcinoma | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Lung cancer metastatic | 1/492 (0.2%) | 0/970 (0%) | 1/1462 (0.1%) | |||
| Lung carcinoma cell type unspecified stage III | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Metastatic gastric cancer | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Neuroendocrine carcinoma of the skin | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Non-small cell lung cancer | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Non-small cell lung cancer stage IV | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Papillary renal cell carcinoma | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Parathyroid tumour benign | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Prostatic adenoma | 1/492 (0.2%) | 0/970 (0%) | 1/1462 (0.1%) | |||
| Rectal cancer | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Rectal neoplasm | 1/492 (0.2%) | 0/970 (0%) | 1/1462 (0.1%) | |||
| Renal cell carcinoma | 1/492 (0.2%) | 0/970 (0%) | 1/1462 (0.1%) | |||
| Squamous cell carcinoma | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Tonsil cancer | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Transitional cell carcinoma | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Nervous system disorders | ||||||
| Carotid artery stenosis | 2/492 (0.4%) | 6/970 (0.6%) | 8/1462 (0.5%) | |||
| Ischaemic stroke | 2/492 (0.4%) | 3/970 (0.3%) | 5/1462 (0.3%) | |||
| Cerebrovascular accident | 1/492 (0.2%) | 3/970 (0.3%) | 4/1462 (0.3%) | |||
| Syncope | 1/492 (0.2%) | 2/970 (0.2%) | 3/1462 (0.2%) | |||
| Carotid artery occlusion | 1/492 (0.2%) | 1/970 (0.1%) | 2/1462 (0.1%) | |||
| Cerebral infarction | 0/492 (0%) | 2/970 (0.2%) | 2/1462 (0.1%) | |||
| Presyncope | 1/492 (0.2%) | 1/970 (0.1%) | 2/1462 (0.1%) | |||
| Toxic encephalopathy | 1/492 (0.2%) | 1/970 (0.1%) | 2/1462 (0.1%) | |||
| Transient ischaemic attack | 0/492 (0%) | 2/970 (0.2%) | 2/1462 (0.1%) | |||
| Carpal tunnel syndrome | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Cerebral haematoma | 1/492 (0.2%) | 0/970 (0%) | 1/1462 (0.1%) | |||
| Dysarthria | 1/492 (0.2%) | 0/970 (0%) | 1/1462 (0.1%) | |||
| External compression headache | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Facial paralysis | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Haemorrhage intracranial | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Intracranial aneurysm | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Unresponsive to stimuli | 1/492 (0.2%) | 0/970 (0%) | 1/1462 (0.1%) | |||
| Vertebrobasilar insufficiency | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Product Issues | ||||||
| Device malfunction | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Renal and urinary disorders | ||||||
| Acute kidney injury | 2/492 (0.4%) | 6/970 (0.6%) | 8/1462 (0.5%) | |||
| Haematuria | 3/492 (0.6%) | 2/970 (0.2%) | 5/1462 (0.3%) | |||
| Ureterolithiasis | 0/492 (0%) | 2/970 (0.2%) | 2/1462 (0.1%) | |||
| Micturition disorder | 1/492 (0.2%) | 0/970 (0%) | 1/1462 (0.1%) | |||
| Renal failure | 1/492 (0.2%) | 0/970 (0%) | 1/1462 (0.1%) | |||
| Reproductive system and breast disorders | ||||||
| Benign prostatic hyperplasia | 1/492 (0.2%) | 0/970 (0%) | 1/1462 (0.1%) | |||
| Prostatitis | 1/492 (0.2%) | 0/970 (0%) | 1/1462 (0.1%) | |||
| Uterine prolapse | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Chronic obstructive pulmonary disease | 0/492 (0%) | 4/970 (0.4%) | 4/1462 (0.3%) | |||
| Pulmonary embolism | 1/492 (0.2%) | 3/970 (0.3%) | 4/1462 (0.3%) | |||
| Dyspnoea | 2/492 (0.4%) | 0/970 (0%) | 2/1462 (0.1%) | |||
| Pleural effusion | 0/492 (0%) | 2/970 (0.2%) | 2/1462 (0.1%) | |||
| Respiratory failure | 1/492 (0.2%) | 1/970 (0.1%) | 2/1462 (0.1%) | |||
| Dyspnoea exertional | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Epistaxis | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Nasal septum deviation | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Pneumothorax | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Respiratory distress | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Dermatitis contact | 1/492 (0.2%) | 0/970 (0%) | 1/1462 (0.1%) | |||
| Haemorrhage subcutaneous | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Skin lesion | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Skin ulcer | 1/492 (0.2%) | 0/970 (0%) | 1/1462 (0.1%) | |||
| Vascular disorders | ||||||
| Peripheral arterial occlusive disease | 3/492 (0.6%) | 5/970 (0.5%) | 8/1462 (0.5%) | |||
| Peripheral ischaemia | 4/492 (0.8%) | 0/970 (0%) | 4/1462 (0.3%) | |||
| Aortic aneurysm | 1/492 (0.2%) | 2/970 (0.2%) | 3/1462 (0.2%) | |||
| Hypertension | 0/492 (0%) | 2/970 (0.2%) | 2/1462 (0.1%) | |||
| Peripheral vascular disorder | 1/492 (0.2%) | 1/970 (0.1%) | 2/1462 (0.1%) | |||
| Angiodysplasia | 1/492 (0.2%) | 0/970 (0%) | 1/1462 (0.1%) | |||
| Aortic stenosis | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Femoral artery aneurysm | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Hypertensive crisis | 1/492 (0.2%) | 0/970 (0%) | 1/1462 (0.1%) | |||
| Hypertensive emergency | 1/492 (0.2%) | 0/970 (0%) | 1/1462 (0.1%) | |||
| Peripheral artery occlusion | 1/492 (0.2%) | 0/970 (0%) | 1/1462 (0.1%) | |||
| Peripheral artery stenosis | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
| Temporal arteritis | 0/492 (0%) | 1/970 (0.1%) | 1/1462 (0.1%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Placebo; Bempedoic Acid | Bempedoic Acid; Bempedoic Acid | OLE Bempedoic Acid | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 108/492 (22%) | 201/970 (20.7%) | 309/1462 (21.1%) | |||
| Infections and infestations | ||||||
| Nasopharyngitis | 33/492 (6.7%) | 86/970 (8.9%) | 119/1462 (8.1%) | |||
| Urinary tract infection | 40/492 (8.1%) | 49/970 (5.1%) | 89/1462 (6.1%) | |||
| Upper respiratory tract infection | 18/492 (3.7%) | 49/970 (5.1%) | 67/1462 (4.6%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Arthralgia | 30/492 (6.1%) | 38/970 (3.9%) | 68/1462 (4.7%) | |||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. If the Principal Investigator plans to publish information from the study, a copy of the manuscript should be provided to the Sponsor for review before submission for publication or presentation. The Sponsor may request that that publication be withheld.
Results Point of Contact
| Name/Title | Medical Director |
|---|---|
| Organization | Esperion Therapeutics, Inc. |
| Phone | 1-833-377-7633 |
| medinfo@esperion.com |
Responsible Party:
Esperion Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT03067441
Other Study ID Numbers:
- 1002-050
- 2016-004115-12
First Posted:
Mar 1, 2017
Last Update Posted:
Mar 1, 2021
Last Verified:
Feb 1, 2021