A Clinical Study to Evaluate the Efficacy, Tolerability, and Safety of Bempedoic Acid
ConditionPrimary Hyperlipidemia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorGan & Lee Pharmaceuticals.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Bempedoic Acid Tablet
- Placebo
Treatment groups
240 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov