Primary Hyperlipidemia
Conditions
Brief summary
This trial is a multicenter randomized, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of Bempedoic Acid Tablets in patients with hyperlipidemia not adequately controlled by Statins.
Interventions
bempedoic acid 180 mg tablet taken orally, once daily. Participants in the experiment remain on ongoing lipid-modifying therapy
DRUGPlacebo
Matching placebo tablet taken orally, once daily. Participants in the experiment remain on ongoing lipid-modifying therapy
Sponsors
CSPC Ouyi Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1\. 18 years and older. 2. 18.5 kg/m2 ≤Body Mass Index (BMI) ≤35 kg/m2. 3. Diagnosis with ASCVD or have high-risk ASCVD, and/or diagnosis with HeFH.4.Be on stable lipid-modifying therapy for at least 4 weeks prior to screening, including moderate to high-dose statins with or without other lipid-modifying therapy (cholesterol absorption inhibitors\[ezetimibe, Hyzetimibe\]，fibrates \[except gemfibrozil\]）; 5.Fasting LDL-C must meet any one of the following 1. For participants with high risk of ASCVD: LDL-C ≥ 2.6 mmol/L (or 100 mg/dL); 2. For participants with extremely high risk of ASCVD: LDL-C≥ 1.8 mmol/L (or 70 mg/dL); 3) For participants with ultra-high risk of ASCVD: LDL-C≥ 1.4 mmol/L (or 55 mg/dL). 6.Fully understand the purpose and requirements of the study, voluntarily participate in the clinical trial, and sign a written informed consent form.
Exclusion criteria
1. Known allergy to any component of the investigational drug or its excipients or related preparations, or a history of allergic diseases (e.g., asthma, urticaria, eczema) or allergic constitution. 2. Diagnosis with HoFH. 3. History of tendon diseases or tendon ruptures before the screening. 4. Severe, uncontrolled concomitant conditions that may affect drug absorption or have a significant impact on lipid level. 5. Hyperthyroidism or uncontrolled hypothyroidism 6. Uncontrolled hypertension 7. Severe cardiovascular or cerebrovascular events in the past 3 months 8. History of nephrotic syndrome or glomerulonephritis or severe renal dysfunction. 9. Liver disease or dysfunction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change from baseline in LDL-C levels at Week 12 | Baseline, Week 12 |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants achieving LDL-C target | Baseline, Week 12 |
| Percentage change from baseline in non-HDL-C、ApoB、TC、hs-CRP levels at Week 12 | Baseline, Week 12 |
| Adverse events (AEs) and serious adverse events (SAEs) during the study | Baseline, Week 13 |
Contacts
CONTACTClinical Trials Information Group officer
Outcome results
None listed