Clinical trial NCT03531905: Bempedoic Acid + Ezetimibe Fixed-Dose Combination (FDC) Study in Patients With Type 2 Diabetes and Elevated LDL-C
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes
Diabetes Mellitus, Type 2
Cholesterolemia
Keywords: diabetes
cholesterolemia
type 2 diabetes
LDL-C
T2D
diabetes mellitus
Lead sponsor: Esperion Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2018-05-22
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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

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.

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

Primary outcomes:
measure: Percent Change From Baseline to Week 12/End of Study (EOS) in Low-density Lipoprotein Cholesterol (LDL-C)
timeFrame: Baseline; Week 12
Secondary outcomes:
measure: Percent Change From Baseline to Week 12/EOS in LDL-C (Comparing Ezetimibe With Placebo)
timeFrame: Baseline; Week 12
measure: Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP)
timeFrame: Baseline; Week 12
measure: Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
timeFrame: Baseline; Week 12
measure: Percent Change From Baseline to Week 12 in Total Cholesterol (TC)
timeFrame: Baseline; Week 12
measure: Percent Change From Baseline to Week 12 in Apolipoprotein B (Apo B)
timeFrame: Baseline; Week 12
measure: Percent Change From Baseline to Week 12 in Triglycerides (TGs)
timeFrame: Baseline; Week 12
measure: Percent Change From Baseline to Week 12 in High-density Lipoprotein Cholesterol (HDL-C)
timeFrame: Baseline; Week 12
measure: Number of Participants With LDL-C <70 Milligrams Per Deciliter (mg/dL) at Week 12
timeFrame: Week 12
measure: Secondary Outcome Measure: Number of Participants With an LDL-C Reduction of ≥50% From Baseline at Week 12
timeFrame: Baseline; Week 12
measure: Change From Baseline to Week 12 in Hemoglobin A1C (HbA1c)
timeFrame: Baseline; Week 12
measure: Percent Change From Baseline to Week 12 in HbA1c
timeFrame: Baseline; Week 12
Other outcomes:
measure: Percent Change From Baseline to Week 12 in Fasting Plasma Glucose
timeFrame: Baseline; Week 12
measure: Percent Change From Baseline to Week 12 in 2-hour Post Prandial Plasma Glucose (PPG)
timeFrame: Baseline; Week 12
measure: Percent Change From Baseline to Week 12 in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) Index
timeFrame: Baseline; Week 12
measure: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
timeFrame: up to approximately 16 weeks
Locations:
city: Lincoln
country: United States
facility: Clinical Trials Research
state: California
city: Miami
country: United States
facility: FInlay Medical Research
state: Florida
city: Louisville
country: United States
facility: L-MARC Research Center
state: Kentucky
city: Suffolk
country: United States
facility: Hampton Roads Center for Clinical Research
state: Virginia
Study officials:
affiliation: Esperion Therapeutics, Inc.
name: Ron Haberman, MD
role: STUDY_DIRECTOR
References:
citation: Gutierrez MJ, Rosenberg NL, Macdougall DE, Hanselman JC, Margulies JR, Strange P, Milad MA, McBride SJ, Newton RS. Efficacy and safety of ETC-1002, a novel investigational low-density lipoprotein-cholesterol-lowering therapy for the treatment of patients with hypercholesterolemia and type 2 diabetes mellitus. Arterioscler Thromb Vasc Biol. 2014 Mar;34(3):676-83. doi: 10.1161/ATVBAHA.113.302677. Epub 2014 Jan 2.