Bempedoic Acid + Ezetimibe Fixed-Dose Combination (FDC) Study in Patients With Type 2 Diabetes and Elevated LDL-C
Sponsor
Esperion Therapeutics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03531905
Collaborator
(none)
242
4
3
13.3
60.5
4.5
Study Details
Study Description
Brief Summary
12 week study to assess the LDL-C lowering efficacy, other lipid and glycemic measures, and safety of bempedoic acid/ezetimibe FDC compared to ezetimibe and placebo in patients with type 2 diabetes (T2D) and elevated LDL-C
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
Assess efficacy of FDC vs. ezetimibe vs. placebo for 12 week LDL-C lowering, changes in atherogenic lipids, hsCRP and exploratory glycemic measures as well as safety in patients with type 2 diabetes and elevated LDL-C.
Study Design
Study Type:
Interventional
Actual Enrollment
:
242 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized Study to Evaluate the Efficacy and Safety of Bempedoic Acid 180 + Ezetimibe 10 Fixed-Dose Combination Compared to Ezetimibe and Placebo In Subjects With T2DM and Elevated LDL-Cholesterol
Actual Study Start Date
:
May 9, 2018
Actual Primary Completion Date
:
Jun 18, 2019
Actual Study Completion Date
:
Jun 18, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Bempedoic acid + Ezetimibe FDC Bempedoic acid + Ezetimibe FDC Oral Tablet; Placebo oral capsule |
Drug: Bempedoic acid + Ezetimibe FDC Oral Tablet
Experimental therapy of bempedoic acid 180 mg + ezetimibe 10 mg FDC tablet
Drug: Placebo oral capsule
Placebo over-encapsulated for blinding purposes
|
| Active Comparator: Ezetimibe 10 mg Ezetimibe 10Mg Oral Tablet; Placebo Oral Tablet |
Drug: Ezetimibe 10 mg Oral Tablet
Ezetimibe 10 mg tablet, overencapsulated for blinding purposes
Other Names:
Drug: Placebo Oral Tablet
Placebo tablet, matched for the FDC product for blinding purposes
|
| Placebo Comparator: Placebo Placebo Oral Tablet, Placebo oral capsule |
Drug: Placebo Oral Tablet
Placebo tablet, matched for the FDC product for blinding purposes
Drug: Placebo oral capsule
Placebo over-encapsulated for blinding purposes
|
Outcome Measures
Primary Outcome Measures
- Percent Change From Baseline to Week 12/End of Study (EOS) in Low-density Lipoprotein Cholesterol (LDL-C) [Baseline; Week 12]
Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for LDL-C. Baseline was defined as the average of LDL-C values at the Screening Visit 3 (Visit S3) and the Treatment Visit 1 (Visit T1) (last 2 non-missing values on or prior to Day 1). If only 1 value was available, the single value was used as Baseline. Percent change from Baseline for LDL-C was analyzed using analysis of covariance (ANCOVA), with treatment as factor and Baseline lipid parameter as a covariate. Missing data for LDL-C was imputed using the last observation carried forward (LOCF) method. Percent change from Baseline was calculated as: ([LDL-C value at Week 12 minus Baseline value] divided by [Baseline value]) multiplied by 100. For LDL-C, if a measured LDL-C value was available, measured LDL-C was used.
Secondary Outcome Measures
- Percent Change From Baseline to Week 12/EOS in LDL-C (Comparing Ezetimibe With Placebo) [Baseline; Week 12]
Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for LDL-C. Baseline was defined as the average of LDL-C values at Visit S3 and Visit T1 (last 2 non-missing values on or prior to Day 1). If only 1 value was available, the single value was used as Baseline. Percent change from Baseline for LDL-C was analyzed using ANCOVA, with treatment as factor and Baseline lipid parameter as a covariate. Missing data for LDL-C was imputed using the LOCF method. Percent change from Baseline was calculated as: ([LDL-C value at Week 12 minus Baseline value] divided by [Baseline value]) multiplied by 100. For LDL-C, if a measured LDL-C value was available, measured LDL-C was used.
- Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP) [Baseline; Week 12]
Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for hsCRP. Baseline was defined as the last value prior to the first dose of investigational medicinal product (IMP). Percent change from Baseline for hsCRP was analyzed using a non-parametric approach. Percent change from Baseline was calculated as: ([hsCRP value at Week 12 minus Baseline value] divided by [Baseline value]) multiplied by 100. For hsCRP, if a measured hsCRP value was available, measured hsCRP was used.
- Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) [Baseline; Week 12]
Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for non-HDL-C. Baseline was defined as the average of non-HDL-C values at Visit S3 and Visit T1 (last 2 non-missing values on or prior to Day 1). If only 1 value was available, the single value was used as Baseline. Percent change from Baseline for non-HDL-C was analyzed using ANCOVA, with treatment as factor and Baseline lipid parameter as a covariate. Missing data for non-HDL-C was imputed using the LOCF method. Percent change from Baseline was calculated as: ([non-HDL-C value at Week 12 minus Baseline value] divided by [Baseline value]) multiplied by 100. For non-HDL-C, if a measured non-HDL-C value was available, measured non-HDL-C was used.
- Percent Change From Baseline to Week 12 in Total Cholesterol (TC) [Baseline; Week 12]
Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for TC. Baseline was defined as the average of TC values at Visit S3 and Visit T1 (last 2 non-missing values on or prior to Day 1). If only 1 value was available, the single value was used as Baseline. Percent change from Baseline for TC was analyzed using ANCOVA, with treatment as factor and Baseline lipid parameter as a covariate. Missing data for TC was imputed using the LOCF method. Percent change from Baseline was calculated as: ([TC value at Week 12 minus Baseline value] divided by [Baseline value]) multiplied by 100. For TC, if a measured TC value was available, measured TC was used.
- Percent Change From Baseline to Week 12 in Apolipoprotein B (Apo B) [Baseline; Week 12]
Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for apo B. Baseline was defined as the last value prior to the first dose of IMP. Percent change from Baseline for TC was analyzed using ANCOVA, with treatment as factor and Baseline lipid parameter as a covariate. Missing data for apo B was imputed using the LOCF method. Percent change from Baseline was calculated as: ([apo B value at Week 12 minus Baseline value] divided by [Baseline value]) multiplied by 100. For apo B, if a measured apo B value was available, measured apo B was used.
- Percent Change From Baseline to Week 12 in Triglycerides (TGs) [Baseline; Week 12]
Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for TGs. Baseline was defined as the average of TG values at Visit S3 and Visit T1 (last 2 non-missing values on or prior to Day 1). If only 1 value was available, the single value was used as Baseline. Percent change from Baseline for TGs was analyzed using a non-parametric approach. Percent change from Baseline was calculated as: ([TG value at Week 12 minus Baseline value] divided by [Baseline value]) multiplied by 100. For TGs, if a measured TG value was available, measured TG was used.
- Percent Change From Baseline to Week 12 in High-density Lipoprotein Cholesterol (HDL-C) [Baseline; Week 12]
Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for HDL-C. Baseline was defined as the average of HDL-C values at Visit S3 and Visit T1 (last 2 non-missing values on or prior to Day 1). If only 1 value was available, the single value was used as Baseline. Percent change from Baseline for HDL-C was analyzed using ANCOVA, with treatment as factor and Baseline lipid parameter as a covariate. Missing data for HDL-C was imputed using the LOCF method. Percent change from Baseline was calculated as: ([HDL-C value at Week 12 minus Baseline value] divided by [Baseline value]) multiplied by 100. For HDL-C, if a measured HDL-C value was available, measured HDL-C was used.
- Number of Participants With LDL-C <70 Milligrams Per Deciliter (mg/dL) at Week 12 [Week 12]
Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for LDL-C. For LDL-C, if a measured LDL-C value was available, measured LDL-C was used.
- Secondary Outcome Measure: Number of Participants With an LDL-C Reduction of ≥50% From Baseline at Week 12 [Baseline; Week 12]
Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for LDL-C. Baseline was defined as the average of LDL-C values at Visit S3 and Visit T1 (last 2 non-missing values on or prior to Day 1). If only 1 value was available, the single value was used as Baseline. LDL-C reduction from Baseline was calculated as the LDL-C value at Week 12 minus the Baseline value. For LDL-C, if a measured LDL-C value was available, measured LDL-C was used.
- Change From Baseline to Week 12 in Hemoglobin A1C (HbA1c) [Baseline; Week 12]
Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for HbA1c. Baseline was defined as the last value prior to the first dose of IMP (on or before Visit T1). Change from Baseline was calculated as the HbA1c value at Week 12 minus the Baseline value. For HbA1c, if a measured HbA1c value was available, measured HbA1c was used.
- Percent Change From Baseline to Week 12 in HbA1c [Baseline; Week 12]
Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for HbA1c. Baseline was defined as the last value prior to the first dose of IMP (on or before Visit T1). Percent change from Baseline for HbA1C was analyzed using ANCOVA, with treatment as factor and Baseline HbA1C value as a covariate. Percent change from Baseline for HbA1c was calculated as: ([HbA1c value at Week 12 minus Baseline value] divided by [Baseline value]) multiplied by 100. For HbA1c, if a measured HbA1c value was available, measured HbA1c was used.
Other Outcome Measures
- Percent Change From Baseline to Week 12 in Fasting Plasma Glucose [Baseline; Week 12]
Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for fasting plasma glucose. Baseline was defined as the last value prior to the first dose of study drug (on or before T1). Percent change from Baseline for fasting plasma glucose was analyzed using ANCOVA, with treatment as factor and Baseline fasting plasma glucose as a covariate. Percent change from Baseline for fasting plasma glucose was calculated as: ([fasting plasma glucose value at Week 12 minus Baseline value] divided by [Baseline value]) multiplied by 100. For fasting plasma glucose, if a measured fasting plasma glucose value was available, measured fasting plasma glucose was used.
- Percent Change From Baseline to Week 12 in 2-hour Post Prandial Plasma Glucose (PPG) [Baseline; Week 12]
Blood samples were drawn 2 hours ± 5 minutes after the start of the meal. Samples were collected and analyzed for PPG. Baseline was defined as the last value prior to the first dose of study drug (on or before T1). Percent change from Baseline for PPG was calculated as: ([PPG value at Week 12 minus Baseline value] divided by [Baseline value]) multiplied by 100. For PPG, if a measured PPG value was available, measured PPG was used.
- Percent Change From Baseline to Week 12 in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) Index [Baseline; Week 12]
The HOMA-IR index was calculated from the fasting glucose and insulin values that were obtained at each clinic visit (Day 1/Visit T1, Week 4/Visit T2, and Week 12/Visit T3) during the double-blind treatment period, using the formula: (fasting glucose [millimoles per milliliter {mmol/ml}] x fasting insulin [micro International Units per milliliter {μIU/ml}]) divided by 22.5. Percent change from Baseline for HOMA-IR index was analyzed using ANCOVA, with treatment as factor and Baseline HOMA-IR index as a covariate. Baseline was defined as the last value prior to the first dose of study drug (on or before T1). Percent change from Baseline for HOMA-IR index was calculated as: ([HOMA-IR index value at Week 12 minus Baseline value] divided by [Baseline value]) multiplied by 100.
- Number of Participants With Any Treatment-emergent Adverse Event (TEAE) [up to approximately 16 weeks]
Treatment-emergent adverse events (TEAEs) are defined as adverse events (AEs) that began or worsened in severity on or after the first dose of double-blind IMP through 30 days after the last dose of double-blind IMP. An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, including control, and which does not necessarily have a causal relationship with treatment. An AE is: any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product; any new disease or exacerbation of an existing disease; any deterioration in non-protocol-required measurements of a laboratory value or other clinical test (e.g., electrocardiogram or x-ray) that results in symptoms, a change in treatment, or discontinuation from IMP; or an adverse drug reaction.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Type 2 diabetes for 6 months or greater
-
Currently taking stable diabetes medication for 3 months or greater
-
HbA1c between 7-10%
-
LDL-cholesterol greater than 70 mg/dL
-
Women must not be pregnant, lactating, or planning to become pregnant within 30 days after last dose of study medication; and must be postmenopausal, surgically sterile, or willing to use 1 acceptable form of birth control during the study through 30 days after the last dose of study medication
Exclusion Criteria:
-
Body mass index > 40 kg/m2
-
History of documented clinically significant cardiovascular disease
-
Fasting triglycerides > 400 mg/dL
-
History of Type 1 diabetes
-
Uncontrolled hypothyroidism, liver dysfunction, renal dysfunction, gastrointestinal condition that may affect drug absorption, hematologic or coagulation disorder or active malignancy
-
History of drug or alcohol abuse within 2 years
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinical Trials Research | Lincoln | California | United States | 95648 |
| 2 | FInlay Medical Research | Miami | Florida | United States | 33126 |
| 3 | L-MARC Research Center | Louisville | Kentucky | United States | 40213 |
| 4 | Hampton Roads Center for Clinical Research | Suffolk | Virginia | United States | 23435 |
Sponsors and Collaborators
- Esperion Therapeutics, Inc.
Investigators
- Study Director: Ron Haberman, MD, Esperion Therapeutics, Inc.
Study Documents (Full-Text)
More Information
Publications
Responsible Party:
Esperion Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT03531905
Other Study ID Numbers:
- 1002FDC-058
First Posted:
May 22, 2018
Last Update Posted:
Apr 9, 2020
Last Verified:
Apr 1, 2020
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 |
| Arm/Group Title | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC | Ezetimibe 10 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Participants received bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 milligrams (mg)/10 mg tablets orally once daily for 12 weeks. | Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks. | Participants received placebo to match the FDC 180 mg/10 mg tablet or the ezetimibe 10 mg overencapsulated tablet, taken orally, once daily for 12 weeks. |
| Period Title: Overall Study | |||
| STARTED | 81 | 81 | 80 |
| COMPLETED | 74 | 76 | 77 |
| NOT COMPLETED | 7 | 5 | 3 |
Baseline Characteristics
| Arm/Group Title | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC | Ezetimibe 10 mg | Placebo | Total |
|---|---|---|---|---|
| Arm/Group Description | Participants received bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 milligrams (mg)/10 mg tablets orally once daily for 12 weeks. | Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks. | Participants received placebo to match the FDC 180 mg/10 mg tablet or the ezetimibe 10 mg overencapsulated tablet, taken orally, once daily for 12 weeks. | Total of all reporting groups |
| Overall Participants | 81 | 81 | 80 | 242 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
61.3
(8.65)
|
61.0
(8.00)
|
62.1
(8.63)
|
61.4
(8.41)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
36
44.4%
|
39
48.1%
|
42
52.5%
|
117
48.3%
|
| Male |
45
55.6%
|
42
51.9%
|
38
47.5%
|
125
51.7%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||
| Hispanic or Latino |
32
39.5%
|
38
46.9%
|
30
37.5%
|
100
41.3%
|
| Not Hispanic or Latino |
49
60.5%
|
43
53.1%
|
50
62.5%
|
142
58.7%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | ||||
| American Indian or Alaska Native |
2
2.5%
|
0
0%
|
0
0%
|
2
0.8%
|
| Asian |
3
3.7%
|
0
0%
|
2
2.5%
|
5
2.1%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
15
18.5%
|
15
18.5%
|
16
20%
|
46
19%
|
| White |
61
75.3%
|
65
80.2%
|
62
77.5%
|
188
77.7%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
1
1.2%
|
0
0%
|
1
0.4%
|
| Low-density lipoprotein cholesterol (LDL-C) (milligrams per deciliter (mg/dL)) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [milligrams per deciliter (mg/dL)] |
145.06
(31.504)
|
139.24
(28.121)
|
143.36
(26.421)
|
142.55
(28.715)
|
| High-sensitivity C-reactive protein (hsCRP) (milligrams per liter (mg/ L)) [Median (Inter-Quartile Range) ] | ||||
| Median (Inter-Quartile Range) [milligrams per liter (mg/ L)] |
2.570
|
2.420
|
3.480
|
2.610
|
| Non-high-density lipoprotein cholesterol (non-HDL-C) (mg/dL) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [mg/dL] |
181.69
(36.659)
|
172.87
(33.277)
|
177.38
(29.116)
|
177.31
(33.194)
|
| Total cholesterol (TC) (mg/dL) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [mg/dL] |
230.34
(37.234)
|
221.33
(33.592)
|
225.94
(32.830)
|
225.87
(34.619)
|
| Apolipoprotein B (Apo B) (mg/dL) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [mg/dL] |
121.6
(22.95)
|
117.3
(22.96)
|
120.8
(18.53)
|
119.9
(21.56)
|
| Triglycerides (TGs) (mg/dL) [Median (Inter-Quartile Range) ] | ||||
| Median (Inter-Quartile Range) [mg/dL] |
172.25
|
159.25
|
163.00
|
163.00
|
| High-density lipoprotein cholesterol (HDL-C) (mg/dL) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [mg/dL] |
48.73
(13.067)
|
47.95
(10.847)
|
48.53
(13.482)
|
48.40
(12.447)
|
| Hemoglobin A1C (HbA1c) (Percent) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [Percent] |
7.86
(0.927)
|
7.96
(1.279)
|
8.02
(0.773)
|
7.95
(1.013)
|
| Fasting plasma glucose (mg/dL) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [mg/dL] |
162.4
(46.10)
|
153.3
(46.73)
|
174.2
(57.53)
|
163.2
(50.78)
|
| HOMA-IR index (units on a scale) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [units on a scale] |
6.709
(6.200)
|
10.847
(18.074)
|
13.267
(21.305)
|
10.199
(16.503)
|
Outcome Measures
| Title | Percent Change From Baseline to Week 12/End of Study (EOS) in Low-density Lipoprotein Cholesterol (LDL-C) |
|---|---|
| Description | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for LDL-C. Baseline was defined as the average of LDL-C values at the Screening Visit 3 (Visit S3) and the Treatment Visit 1 (Visit T1) (last 2 non-missing values on or prior to Day 1). If only 1 value was available, the single value was used as Baseline. Percent change from Baseline for LDL-C was analyzed using analysis of covariance (ANCOVA), with treatment as factor and Baseline lipid parameter as a covariate. Missing data for LDL-C was imputed using the last observation carried forward (LOCF) method. Percent change from Baseline was calculated as: ([LDL-C value at Week 12 minus Baseline value] divided by [Baseline value]) multiplied by 100. For LDL-C, if a measured LDL-C value was available, measured LDL-C was used. |
| Time Frame | Baseline; Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy Analysis Set (EAS): all randomized participants who received at least one dose of investigational medicinal product (Full Analysis Set), excluding participants at three study sites. Only participants with available data were analyzed. |
| Arm/Group Title | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC | Ezetimibe 10 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Participants received bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 milligrams (mg)/10 mg tablets orally once daily for 12 weeks. | Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks. | Participants received placebo to match the FDC 180 mg/10 mg tablet or the ezetimibe 10 mg overencapsulated tablet, taken orally, once daily for 12 weeks. |
| Measure Participants | 55 | 59 | 57 |
| Geometric Least Squares Mean (Standard Error) [Percent change] |
-38.8
(2.24)
|
-19.2
(2.16)
|
0.9
(2.20)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference of Least Squares (LS) means |
| Estimated Value | -39.6 | |
| Confidence Interval |
(2-Sided) 95% -45.8 to -33.4 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.14 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC, Ezetimibe 10 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference of LS means |
| Estimated Value | -19.5 | |
| Confidence Interval |
(2-Sided) 95% -25.7 to -13.4 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.11 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Ezetimibe 10 mg, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference of LS means |
| Estimated Value | -20.1 | |
| Confidence Interval |
(2-Sided) 95% -26.2 to -14.0 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.08 |
|
| Estimation Comments | ||
| Title | Percent Change From Baseline to Week 12/EOS in LDL-C (Comparing Ezetimibe With Placebo) |
|---|---|
| Description | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for LDL-C. Baseline was defined as the average of LDL-C values at Visit S3 and Visit T1 (last 2 non-missing values on or prior to Day 1). If only 1 value was available, the single value was used as Baseline. Percent change from Baseline for LDL-C was analyzed using ANCOVA, with treatment as factor and Baseline lipid parameter as a covariate. Missing data for LDL-C was imputed using the LOCF method. Percent change from Baseline was calculated as: ([LDL-C value at Week 12 minus Baseline value] divided by [Baseline value]) multiplied by 100. For LDL-C, if a measured LDL-C value was available, measured LDL-C was used. |
| Time Frame | Baseline; Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| EAS. Only participants with available data were analyzed. |
| Arm/Group Title | Ezetimibe 10 mg | Placebo |
|---|---|---|
| Arm/Group Description | Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks. | Participants received placebo to match the FDC 180 mg/10 mg tablet or the ezetimibe 10 mg overencapsulated tablet, taken orally, once daily for 12 weeks. |
| Measure Participants | 59 | 57 |
| Least Squares Mean (Standard Error) [Percent change] |
-19.2
(2.16)
|
0.9
(2.20)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC, Ezetimibe 10 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference of LS means |
| Estimated Value | -20.1 | |
| Confidence Interval |
(2-Sided) 95% -26.2 to -14.0 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 3.08 |
|
| Estimation Comments | ||
| Title | Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP) |
|---|---|
| Description | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for hsCRP. Baseline was defined as the last value prior to the first dose of investigational medicinal product (IMP). Percent change from Baseline for hsCRP was analyzed using a non-parametric approach. Percent change from Baseline was calculated as: ([hsCRP value at Week 12 minus Baseline value] divided by [Baseline value]) multiplied by 100. For hsCRP, if a measured hsCRP value was available, measured hsCRP was used. |
| Time Frame | Baseline; Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| EAS. Only participants with available data were analyzed. |
| Arm/Group Title | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC | Ezetimibe 10 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Participants received bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 milligrams (mg)/10 mg tablets orally once daily for 12 weeks. | Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks. | Participants received placebo to match the FDC 180 mg/10 mg tablet or the ezetimibe 10 mg overencapsulated tablet, taken orally, once daily for 12 weeks. |
| Measure Participants | 54 | 56 | 57 |
| Median (Inter-Quartile Range) [Percent change] |
-25.347
|
2.078
|
14.085
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Wilcoxon rank sum test | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Location shift |
| Estimated Value | -36.7 | |
| Confidence Interval |
(2-Sided) 95% -55.97 to -17.67 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 9.77 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC, Ezetimibe 10 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.005 |
| Comments | ||
| Method | Wilcoxon rank sum test | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Location shift |
| Estimated Value | -29.2 | |
| Confidence Interval |
(2-Sided) 95% -48.92 to -9.62 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 10.03 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Ezetimibe 10 mg, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.480 |
| Comments | ||
| Method | Wilcoxon rank sum test | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Location shift |
| Estimated Value | -7.5 | |
| Confidence Interval |
(2-Sided) 95% -30.51 to 13.76 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 11.29 |
|
| Estimation Comments | ||
| Title | Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) |
|---|---|
| Description | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for non-HDL-C. Baseline was defined as the average of non-HDL-C values at Visit S3 and Visit T1 (last 2 non-missing values on or prior to Day 1). If only 1 value was available, the single value was used as Baseline. Percent change from Baseline for non-HDL-C was analyzed using ANCOVA, with treatment as factor and Baseline lipid parameter as a covariate. Missing data for non-HDL-C was imputed using the LOCF method. Percent change from Baseline was calculated as: ([non-HDL-C value at Week 12 minus Baseline value] divided by [Baseline value]) multiplied by 100. For non-HDL-C, if a measured non-HDL-C value was available, measured non-HDL-C was used. |
| Time Frame | Baseline; Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| EAS. Only participants with available data were analyzed. |
| Arm/Group Title | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC | Ezetimibe 10 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Participants received bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 milligrams (mg)/10 mg tablets orally once daily for 12 weeks. | Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks. | Participants received placebo to match the FDC 180 mg/10 mg tablet or the ezetimibe 10 mg overencapsulated tablet, taken orally, once daily for 12 weeks. |
| Measure Participants | 55 | 59 | 57 |
| Least Squares Mean (Standard Error) [Percent change] |
-33.0
(2.01)
|
-17.8
(1.94)
|
0.1
(1.97)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference of LS means |
| Estimated Value | -33.1 | |
| Confidence Interval |
(2-Sided) 95% -38.6 to -27.5 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.81 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC, Ezetimibe 10 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference of LS means |
| Estimated Value | -15.3 | |
| Confidence Interval |
(2-Sided) 95% -20.8 to -9.7 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.80 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Ezetimibe 10 mg, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference of LS means |
| Estimated Value | -17.8 | |
| Confidence Interval |
(2-Sided) 95% -23.3 to -12.4 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.76 |
|
| Estimation Comments | ||
| Title | Percent Change From Baseline to Week 12 in Total Cholesterol (TC) |
|---|---|
| Description | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for TC. Baseline was defined as the average of TC values at Visit S3 and Visit T1 (last 2 non-missing values on or prior to Day 1). If only 1 value was available, the single value was used as Baseline. Percent change from Baseline for TC was analyzed using ANCOVA, with treatment as factor and Baseline lipid parameter as a covariate. Missing data for TC was imputed using the LOCF method. Percent change from Baseline was calculated as: ([TC value at Week 12 minus Baseline value] divided by [Baseline value]) multiplied by 100. For TC, if a measured TC value was available, measured TC was used. |
| Time Frame | Baseline; Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| EAS. Only participants with available data were analyzed. |
| Arm/Group Title | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC | Ezetimibe 10 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Participants received bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 milligrams (mg)/10 mg tablets orally once daily for 12 weeks. | Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks. | Participants received placebo to match the FDC 180 mg/10 mg tablet or the ezetimibe 10 mg overencapsulated tablet, taken orally, once daily for 12 weeks. |
| Measure Participants | 55 | 59 | 57 |
| Least Squares Mean (Standard Error) [Percent change] |
-27.3
(1.61)
|
-13.9
(1.55)
|
-0.1
(1.57)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference of LS means |
| Estimated Value | -27.2 | |
| Confidence Interval |
(2-Sided) 95% -31.7 to -22.8 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.25 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC, Ezetimibe 10 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference of LS means |
| Estimated Value | -13.4 | |
| Confidence Interval |
(2-Sided) 95% -17.8 to -9.0 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.24 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Ezetimibe 10 mg, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference of LS means |
| Estimated Value | -13.9 | |
| Confidence Interval |
(2-Sided) 95% -18.2 to -9.5 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.21 |
|
| Estimation Comments | ||
| Title | Percent Change From Baseline to Week 12 in Apolipoprotein B (Apo B) |
|---|---|
| Description | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for apo B. Baseline was defined as the last value prior to the first dose of IMP. Percent change from Baseline for TC was analyzed using ANCOVA, with treatment as factor and Baseline lipid parameter as a covariate. Missing data for apo B was imputed using the LOCF method. Percent change from Baseline was calculated as: ([apo B value at Week 12 minus Baseline value] divided by [Baseline value]) multiplied by 100. For apo B, if a measured apo B value was available, measured apo B was used. |
| Time Frame | Baseline; Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| EAS. Only participants with available data were analyzed. |
| Arm/Group Title | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC | Ezetimibe 10 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Participants received bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 milligrams (mg)/10 mg tablets orally once daily for 12 weeks. | Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks. | Participants received placebo to match the FDC 180 mg/10 mg tablet or the ezetimibe 10 mg overencapsulated tablet, taken orally, once daily for 12 weeks. |
| Measure Participants | 55 | 59 | 57 |
| Least Squares Mean (Standard Error) [Percent change] |
-27.5
(1.94)
|
-14.8
(1.88)
|
-0.3
(1.91)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference of LS means |
| Estimated Value | -27.2 | |
| Confidence Interval |
(2-Sided) 95% -32.6 to -21.8 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.73 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC, Ezetimibe 10 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference of LS means |
| Estimated Value | -12.8 | |
| Confidence Interval |
(2-Sided) 95% -18.1 to -7.4 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.71 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Ezetimibe 10 mg, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference of LS means |
| Estimated Value | -14.4 | |
| Confidence Interval |
(2-Sided) 95% -19.7 to -9.1 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.68 |
|
| Estimation Comments | ||
| Title | Percent Change From Baseline to Week 12 in Triglycerides (TGs) |
|---|---|
| Description | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for TGs. Baseline was defined as the average of TG values at Visit S3 and Visit T1 (last 2 non-missing values on or prior to Day 1). If only 1 value was available, the single value was used as Baseline. Percent change from Baseline for TGs was analyzed using a non-parametric approach. Percent change from Baseline was calculated as: ([TG value at Week 12 minus Baseline value] divided by [Baseline value]) multiplied by 100. For TGs, if a measured TG value was available, measured TG was used. |
| Time Frame | Baseline; Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| EAS. Only participants with available data were analyzed. |
| Arm/Group Title | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC | Ezetimibe 10 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Participants received bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 milligrams (mg)/10 mg tablets orally once daily for 12 weeks. | Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks. | Participants received placebo to match the FDC 180 mg/10 mg tablet or the ezetimibe 10 mg overencapsulated tablet, taken orally, once daily for 12 weeks. |
| Measure Participants | 54 | 56 | 57 |
| Median (Inter-Quartile Range) [Percent change] |
-9.20
|
-13.59
|
-5.11
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.457 |
| Comments | ||
| Method | Wilcoxon rank sum test | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Location shift |
| Estimated Value | -3.9 | |
| Confidence Interval |
(2-Sided) 95% -14.55 to 6.79 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 5.44 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC, Ezetimibe 10 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.351 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference of LS means |
| Estimated Value | 4.7 | |
| Confidence Interval |
(2-Sided) 95% -4.93 to 15.63 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 5.25 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Ezetimibe 10 mg, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.068 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference of LS means |
| Estimated Value | -9.2 | |
| Confidence Interval |
(2-Sided) 95% -17.92 to 0.68 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 4.75 |
|
| Estimation Comments | ||
| Title | Percent Change From Baseline to Week 12 in High-density Lipoprotein Cholesterol (HDL-C) |
|---|---|
| Description | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for HDL-C. Baseline was defined as the average of HDL-C values at Visit S3 and Visit T1 (last 2 non-missing values on or prior to Day 1). If only 1 value was available, the single value was used as Baseline. Percent change from Baseline for HDL-C was analyzed using ANCOVA, with treatment as factor and Baseline lipid parameter as a covariate. Missing data for HDL-C was imputed using the LOCF method. Percent change from Baseline was calculated as: ([HDL-C value at Week 12 minus Baseline value] divided by [Baseline value]) multiplied by 100. For HDL-C, if a measured HDL-C value was available, measured HDL-C was used. |
| Time Frame | Baseline; Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| EAS. Only participants with available data were analyzed. |
| Arm/Group Title | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC | Ezetimibe 10 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Participants received bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 milligrams (mg)/10 mg tablets orally once daily for 12 weeks. | Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks. | Participants received placebo to match the FDC 180 mg/10 mg tablet or the ezetimibe 10 mg overencapsulated tablet, taken orally, once daily for 12 weeks. |
| Measure Participants | 55 | 59 | 57 |
| Least Squares Mean (Standard Error) [Percent change] |
-5.1
(1.53)
|
2.1
(1.48)
|
0.8
(1.50)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.007 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference of LS means |
| Estimated Value | -5.9 | |
| Confidence Interval |
(2-Sided) 95% -10.1 to -1.7 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.14 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC, Ezetimibe 10 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference of LS means |
| Estimated Value | -7.3 | |
| Confidence Interval |
(2-Sided) 95% -11.5 to -3.1 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.12 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Ezetimibe 10 mg, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.517 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference of LS means |
| Estimated Value | 1.4 | |
| Confidence Interval |
(2-Sided) 95% -2.8 to 5.5 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.11 |
|
| Estimation Comments | ||
| Title | Number of Participants With LDL-C <70 Milligrams Per Deciliter (mg/dL) at Week 12 |
|---|---|
| Description | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for LDL-C. For LDL-C, if a measured LDL-C value was available, measured LDL-C was used. |
| Time Frame | Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| EAS. Only participants with available data were analyzed. |
| Arm/Group Title | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC | Ezetimibe 10 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Participants received bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 milligrams (mg)/10 mg tablets orally once daily for 12 weeks. | Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks. | Participants received placebo to match the FDC 180 mg/10 mg tablet or the ezetimibe 10 mg overencapsulated tablet, taken orally, once daily for 12 weeks. |
| Measure Participants | 54 | 56 | 57 |
| Count of Participants [Participants] |
21
25.9%
|
3
3.7%
|
0
0%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Ezetimibe 10 mg, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.118 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC, Ezetimibe 10 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
| Title | Secondary Outcome Measure: Number of Participants With an LDL-C Reduction of ≥50% From Baseline at Week 12 |
|---|---|
| Description | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for LDL-C. Baseline was defined as the average of LDL-C values at Visit S3 and Visit T1 (last 2 non-missing values on or prior to Day 1). If only 1 value was available, the single value was used as Baseline. LDL-C reduction from Baseline was calculated as the LDL-C value at Week 12 minus the Baseline value. For LDL-C, if a measured LDL-C value was available, measured LDL-C was used. |
| Time Frame | Baseline; Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| EAS. Only participants with available data were analyzed. |
| Arm/Group Title | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC | Ezetimibe 10 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Participants received bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 milligrams (mg)/10 mg tablets orally once daily for 12 weeks. | Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks. | Participants received placebo to match the FDC 180 mg/10 mg tablet or the ezetimibe 10 mg overencapsulated tablet, taken orally, once daily for 12 weeks. |
| Measure Participants | 54 | 56 | 57 |
| Count of Participants [Participants] |
22
27.2%
|
0
0%
|
0
0%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC, Ezetimibe 10 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
| Title | Change From Baseline to Week 12 in Hemoglobin A1C (HbA1c) |
|---|---|
| Description | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for HbA1c. Baseline was defined as the last value prior to the first dose of IMP (on or before Visit T1). Change from Baseline was calculated as the HbA1c value at Week 12 minus the Baseline value. For HbA1c, if a measured HbA1c value was available, measured HbA1c was used. |
| Time Frame | Baseline; Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| EAS. Only participants with available data were analyzed. |
| Arm/Group Title | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC | Ezetimibe 10 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Participants received bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 milligrams (mg)/10 mg tablets orally once daily for 12 weeks. | Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks. | Participants received placebo to match the FDC 180 mg/10 mg tablet or the ezetimibe 10 mg overencapsulated tablet, taken orally, once daily for 12 weeks. |
| Measure Participants | 54 | 56 | 57 |
| Mean (Standard Deviation) [mg/dL] |
0.01
(0.849)
|
-0.06
(0.851)
|
0.03
(0.667)
|
| Title | Percent Change From Baseline to Week 12 in HbA1c |
|---|---|
| Description | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for HbA1c. Baseline was defined as the last value prior to the first dose of IMP (on or before Visit T1). Percent change from Baseline for HbA1C was analyzed using ANCOVA, with treatment as factor and Baseline HbA1C value as a covariate. Percent change from Baseline for HbA1c was calculated as: ([HbA1c value at Week 12 minus Baseline value] divided by [Baseline value]) multiplied by 100. For HbA1c, if a measured HbA1c value was available, measured HbA1c was used. |
| Time Frame | Baseline; Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| EAS. Only participants with available data were analyzed. |
| Arm/Group Title | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC | Ezetimibe 10 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Participants received bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 milligrams (mg)/10 mg tablets orally once daily for 12 weeks. | Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks. | Participants received placebo to match the FDC 180 mg/10 mg tablet or the ezetimibe 10 mg overencapsulated tablet, taken orally, once daily for 12 weeks. |
| Measure Participants | 54 | 56 | 57 |
| Least Squares Mean (Standard Error) [Percent change] |
0.1
(1.31)
|
-0.7
(1.28)
|
0.4
(1.27)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.877 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference of LS means |
| Estimated Value | -0.3 | |
| Confidence Interval |
(2-Sided) 95% -3.9 to 3.3 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.83 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC, Ezetimibe 10 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.669 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference of LS means |
| Estimated Value | 0.8 | |
| Confidence Interval |
(2-Sided) 95% -2.8 to 4.4 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.83 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Ezetimibe 10 mg, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.556 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference of LS means |
| Estimated Value | -1.1 | |
| Confidence Interval |
(2-Sided) 95% -4.6 to 2.5 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.81 |
|
| Estimation Comments | ||
| Title | Percent Change From Baseline to Week 12 in Fasting Plasma Glucose |
|---|---|
| Description | Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for fasting plasma glucose. Baseline was defined as the last value prior to the first dose of study drug (on or before T1). Percent change from Baseline for fasting plasma glucose was analyzed using ANCOVA, with treatment as factor and Baseline fasting plasma glucose as a covariate. Percent change from Baseline for fasting plasma glucose was calculated as: ([fasting plasma glucose value at Week 12 minus Baseline value] divided by [Baseline value]) multiplied by 100. For fasting plasma glucose, if a measured fasting plasma glucose value was available, measured fasting plasma glucose was used. |
| Time Frame | Baseline; Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| EAS. Only participants with available data were analyzed. |
| Arm/Group Title | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC | Ezetimibe 10 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Participants received bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 milligrams (mg)/10 mg tablets orally once daily for 12 weeks. | Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks. | Participants received placebo to match the FDC 180 mg/10 mg tablet or the ezetimibe 10 mg overencapsulated tablet, taken orally, once daily for 12 weeks. |
| Measure Participants | 53 | 55 | 55 |
| Least Squares Mean (Standard Error) [Percent change] |
4.2
(3.29)
|
3.7
(3.28)
|
1.7
(3.27)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.589 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference of LS means |
| Estimated Value | 2.5 | |
| Confidence Interval |
(2-Sided) 95% -6.7 to 11.7 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 4.64 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC, Ezetimibe 10 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.904 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference of LS means |
| Estimated Value | 0.6 | |
| Confidence Interval |
(2-Sided) 95% -8.6 to 9.7 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 4.64 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Ezetimibe 10 mg, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.676 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference of LS means |
| Estimated Value | 2.0 | |
| Confidence Interval |
(2-Sided) 95% -7.3 to 11.2 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 4.66 |
|
| Estimation Comments | ||
| Title | Percent Change From Baseline to Week 12 in 2-hour Post Prandial Plasma Glucose (PPG) |
|---|---|
| Description | Blood samples were drawn 2 hours ± 5 minutes after the start of the meal. Samples were collected and analyzed for PPG. Baseline was defined as the last value prior to the first dose of study drug (on or before T1). Percent change from Baseline for PPG was calculated as: ([PPG value at Week 12 minus Baseline value] divided by [Baseline value]) multiplied by 100. For PPG, if a measured PPG value was available, measured PPG was used. |
| Time Frame | Baseline; Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| EAS. Only participants with available data were analyzed. |
| Arm/Group Title | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC | Ezetimibe 10 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Participants received bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 milligrams (mg)/10 mg tablets orally once daily for 12 weeks. | Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks. | Participants received placebo to match the FDC 180 mg/10 mg tablet or the ezetimibe 10 mg overencapsulated tablet, taken orally, once daily for 12 weeks. |
| Measure Participants | 55 | 53 | 50 |
| Mean (Standard Deviation) [Percent change] |
1.9
(24.25)
|
0.2
(31.88)
|
2.2
(25.39)
|
| Title | Percent Change From Baseline to Week 12 in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) Index |
|---|---|
| Description | The HOMA-IR index was calculated from the fasting glucose and insulin values that were obtained at each clinic visit (Day 1/Visit T1, Week 4/Visit T2, and Week 12/Visit T3) during the double-blind treatment period, using the formula: (fasting glucose [millimoles per milliliter {mmol/ml}] x fasting insulin [micro International Units per milliliter {μIU/ml}]) divided by 22.5. Percent change from Baseline for HOMA-IR index was analyzed using ANCOVA, with treatment as factor and Baseline HOMA-IR index as a covariate. Baseline was defined as the last value prior to the first dose of study drug (on or before T1). Percent change from Baseline for HOMA-IR index was calculated as: ([HOMA-IR index value at Week 12 minus Baseline value] divided by [Baseline value]) multiplied by 100. |
| Time Frame | Baseline; Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| EAS. Only participants with available data were analyzed. |
| Arm/Group Title | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC | Ezetimibe 10 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Participants received bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 milligrams (mg)/10 mg tablets orally once daily for 12 weeks. | Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks. | Participants received placebo to match the FDC 180 mg/10 mg tablet or the ezetimibe 10 mg overencapsulated tablet, taken orally, once daily for 12 weeks. |
| Measure Participants | 51 | 53 | 55 |
| Least Squares Mean (Standard Error) [Percent change] |
3.0
(9.85)
|
2.5
(9.59)
|
18.9
(9.79)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.258 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference of LS means |
| Estimated Value | -15.8 | |
| Confidence Interval |
(2-Sided) 95% -43.4 to 11.7 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 13.95 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC, Ezetimibe 10 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.972 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference of LS means |
| Estimated Value | 0.5 | |
| Confidence Interval |
(2-Sided) 95% -26.8 to 27.7 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 13.79 |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Ezetimibe 10 mg, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.235 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference of LS means |
| Estimated Value | -16.3 | |
| Confidence Interval |
(2-Sided) 95% -43.3 to 10.7 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 13.68 |
|
| Estimation Comments | ||
| Title | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) |
|---|---|
| Description | Treatment-emergent adverse events (TEAEs) are defined as adverse events (AEs) that began or worsened in severity on or after the first dose of double-blind IMP through 30 days after the last dose of double-blind IMP. An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, including control, and which does not necessarily have a causal relationship with treatment. An AE is: any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product; any new disease or exacerbation of an existing disease; any deterioration in non-protocol-required measurements of a laboratory value or other clinical test (e.g., electrocardiogram or x-ray) that results in symptoms, a change in treatment, or discontinuation from IMP; or an adverse drug reaction. |
| Time Frame | up to approximately 16 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Analysis Set: all randomized participants who received at least one dose of IMP |
| Arm/Group Title | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC | Ezetimibe 10 mg | Placebo |
|---|---|---|---|
| Arm/Group Description | Participants received bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 milligrams (mg)/10 mg tablets orally once daily for 12 weeks. | Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks. | Participants received placebo to match the FDC 180 mg/10 mg tablet or the ezetimibe 10 mg overencapsulated tablet, taken orally, once daily for 12 weeks. |
| Measure Participants | 81 | 81 | 80 |
| Count of Participants [Participants] |
55
67.9%
|
45
55.6%
|
46
57.5%
|
Adverse Events
| Time Frame | up to approximately 16 weeks | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Treatment-emergent adverse events (TEAEs), defined as adverse events (AEs) that began or worsened in severity on or after the first dose of double-blind investigational medicinal product (IMP) through 30 days after the last dose of double-blind IMP, were collected in members of the Safety Population (all randomized participants who received at least 1 dose of blinded IMP). | |||||
| Arm/Group Title | Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC | Ezetimibe 10 mg | Placebo | |||
| Arm/Group Description | Participants received bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 milligrams (mg)/10 mg tablets orally once daily for 12 weeks. | Participants received ezetimibe 10 mg overencapsulated tablets orally once daily for 12 weeks. | Participants received placebo to match the FDC 180 mg/10 mg tablet or the ezetimibe 10 mg overencapsulated tablet, taken orally, once daily for 12 weeks. | |||
All Cause Mortality |
||||||
| Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC | Ezetimibe 10 mg | Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/81 (0%) | 0/81 (0%) | 0/80 (0%) | |||
Serious Adverse Events |
||||||
| Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC | Ezetimibe 10 mg | Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/81 (0%) | 1/81 (1.2%) | 1/80 (1.3%) | |||
| Gastrointestinal disorders | ||||||
| Duodenal ulcer | 0/81 (0%) | 1/81 (1.2%) | 0/80 (0%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Angioedema | 0/81 (0%) | 0/81 (0%) | 1/80 (1.3%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Bempedoic Acid 180 mg + Ezetimibe 10 mg FDC | Ezetimibe 10 mg | Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 8/81 (9.9%) | 6/81 (7.4%) | 7/80 (8.8%) | |||
| Infections and infestations | ||||||
| Bronchitis | 0/81 (0%) | 3/81 (3.7%) | 0/80 (0%) | |||
| Urinary tract infection | 3/81 (3.7%) | 3/81 (3.7%) | 3/80 (3.8%) | |||
| Investigations | ||||||
| Blood glucose increased | 3/81 (3.7%) | 0/81 (0%) | 0/80 (0%) | |||
| Glycosylated haemoglobin increased | 2/81 (2.5%) | 1/81 (1.2%) | 4/80 (5%) | |||
Limitations/Caveats
Sites 5801003, 5801041, and 5801043 were suspected of Good Clinical Practice violations in an earlier Phase 3 trial (NCT03337308), hence the Efficacy Analysis Set (which excluded these 3 sites) was designated as the primary efficacy analysis set.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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:
NCT03531905
Other Study ID Numbers:
- 1002FDC-058
First Posted:
May 22, 2018
Last Update Posted:
Apr 9, 2020
Last Verified:
Apr 1, 2020