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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 242
- 试验地点
- 4
- 主要终点
- Percent Change From Baseline to Week 12/End of Study (EOS) in Low-density Lipoprotein Cholesterol (LDL-C)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Bempedoic acid + Ezetimibe FDC
Bempedoic acid + Ezetimibe FDC Oral Tablet; Placebo oral capsule
干预措施: Bempedoic acid + Ezetimibe FDC Oral Tablet (Drug)
Bempedoic acid + Ezetimibe FDC
Bempedoic acid + Ezetimibe FDC Oral Tablet; Placebo oral capsule
干预措施: Placebo oral capsule (Drug)
Ezetimibe 10 mg
Ezetimibe 10Mg Oral Tablet; Placebo Oral Tablet
干预措施: Ezetimibe 10 mg Oral Tablet (Drug)
Ezetimibe 10 mg
Ezetimibe 10Mg Oral Tablet; Placebo Oral Tablet
干预措施: Placebo Oral Tablet (Drug)
Placebo
Placebo Oral Tablet, Placebo oral capsule
干预措施: Placebo Oral Tablet (Drug)
Placebo
Placebo Oral Tablet, Placebo oral capsule
干预措施: Placebo oral capsule (Drug)
结局指标
主要结局
Percent Change From Baseline to Week 12/End of Study (EOS) in Low-density Lipoprotein Cholesterol (LDL-C)
时间窗: 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.
次要结局
- Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP)(Baseline; Week 12)
- Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)(Baseline; Week 12)
- Percent Change From Baseline to Week 12 in Total Cholesterol (TC)(Baseline; Week 12)
- Percent Change From Baseline to Week 12/EOS in LDL-C (Comparing Ezetimibe With Placebo)(Baseline; Week 12)
- Percent Change From Baseline to Week 12 in Apolipoprotein B (Apo B)(Baseline; Week 12)
- Percent Change From Baseline to Week 12 in Triglycerides (TGs)(Baseline; Week 12)
- Percent Change From Baseline to Week 12 in High-density Lipoprotein Cholesterol (HDL-C)(Baseline; Week 12)
- Number of Participants With LDL-C <70 Milligrams Per Deciliter (mg/dL) at Week 12(Week 12)
- Secondary Outcome Measure: Number of Participants With an LDL-C Reduction of ≥50% From Baseline at Week 12(Baseline; Week 12)
- Change From Baseline to Week 12 in Hemoglobin A1C (HbA1c)(Baseline; Week 12)
- Percent Change From Baseline to Week 12 in HbA1c(Baseline; Week 12)