Phase 2
N=242
Bempedoic Acid + Ezetimibe Fixed-Dose Combination (FDC) Study in Patients With Type 2 Diabetes and Elevated LDL-C
Diabetes · Diabetes Mellitus, Type 2 · Cholesterolemia
Bottom Line
View on ClinicalTrials.gov: NCT03531905 ↗Enrolled (actual)
242
Serious AEs
0.8%
Results posted
Apr 2020
Primary outcome: Primary: Percent Change From Baseline to Week 12/End of Study (EOS) in Low-density Lipoprotein Cholesterol (LDL-C) — -38.8; -19.2; 0.9 Percent change — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Bempedoic acid + Ezetimibe FDC Oral Tablet (Drug); Ezetimibe 10 mg Oral Tablet (Drug); Placebo Oral Tablet (Drug); Placebo oral capsule (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Esperion Therapeutics, Inc.
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline to Week 12/End of Study (EOS) in Low-density Lipoprotein Cholesterol (LDL-C) |
-38.8; -19.2; 0.9 | <0.001 sig |
| SECONDARY Percent Change From Baseline to Week 12/EOS in LDL-C (Comparing Ezetimibe With Placebo) |
-19.2; 0.9 | <0.001 sig |
| SECONDARY Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP) |
-25.347; 2.078; 14.085 | <0.001 sig |
| SECONDARY Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) |
-33.0; -17.8; 0.1 | <0.001 sig |
| SECONDARY Percent Change From Baseline to Week 12 in Total Cholesterol (TC) |
-27.3; -13.9; -0.1 | <0.001 sig |
| SECONDARY Percent Change From Baseline to Week 12 in Apolipoprotein B (Apo B) |
-27.5; -14.8; -0.3 | <0.001 sig |
| SECONDARY Percent Change From Baseline to Week 12 in Triglycerides (TGs) |
-9.20; -13.59; -5.11 | 0.457 |
| SECONDARY Percent Change From Baseline to Week 12 in High-density Lipoprotein Cholesterol (HDL-C) |
-5.1; 2.1; 0.8 | 0.007 sig |
| SECONDARY Number of Participants With LDL-C <70 Milligrams Per Deciliter (mg/dL) at Week 12 |
21; 3; 0 | <0.001 sig |
| SECONDARY Secondary Outcome Measure: Number of Participants With an LDL-C Reduction of ≥50% From Baseline at Week 12 |
22; 0; 0 | <0.001 sig |
| SECONDARY Change From Baseline to Week 12 in Hemoglobin A1C (HbA1c) |
0.01; -0.06; 0.03 | — |
| SECONDARY Percent Change From Baseline to Week 12 in HbA1c |
0.1; -0.7; 0.4 | 0.877 |
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
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03531905). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.