Primary Hyperlipidemia
Conditions
Keywords
Bempedoic Acid, Hyperlipidemia, Efficacy, Safety
Brief summary
This trial is a phase III study to evaluate the efficacy , tolerability, and safety of Bempedoic Acid Tablets in patients with hyperlipidemia not adequately controlled by Statins.
Interventions
Once daily, oral
DRUGPlacebo
Once daily, oral
Sponsors
Gan & Lee Pharmaceuticals.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 1\. 18 years and older, male or female. * 2\. 18 kg/m2 ≤Body Mass Index (BMI) ≤35 kg/m2. * 3\. Participants must agree to use reliable contraception from the screening day until 30 days after the last dose, and must not donate sperm or eggs for assisted reproduction purposes. * 4\. Fully understand the purpose and requirements of the study, voluntarily participate in the clinical trial, and sign a written informed consent form, capable of completing the entire study process.
Exclusion criteria
* 1\. Known allergy to any component of the investigational drug or its excipients, or a history of allergic diseases (e.g., asthma, urticaria, eczema) or allergic constitution. * 2\. Fasting triglycerides (TG) ≥ 5.64 mmol/L (≥ 500 mg/dL) at screening. * 3\. History of malignant tumors prior to screening. * 4\. History of drug, alcohol, amphetamines, or other drug abuse. * 5\. Participation in other clinical studies and use of other investigational drugs or medical devices within 3 months prior to screening or within 5 half-lives of the drugs (whichever is longer). * 6\. Pregnant or breastfeeding females, or those with a positive human chorionic gonadotropin (HCG) pregnancy test. * 7\. Any other factors that the investigator believes makes the participant unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change from baseline in LDL-C levels at Week 12 | Baseline, Week 12 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage change from baseline in total cholesterol (TC) levels at Week 12 | Baseline, Week 12 |
| Adverse events (AEs) and serious adverse events (SAEs) during the study | Baseline, Week 13 |
Countries
China
Contacts
Primary ContactWei Zhao
Outcome results
None listed