A Clinical Study to Evaluate the Efficacy, Tolerability, and Safety of Bempedoic Acid

Gan & Lee Pharmaceuticals.

Status and phase: Enrolling; Phase 3

Conditions: Primary Hyperlipidemia

Treatments: Drug: Placebo; Drug: Bempedoic Acid Tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT06780410

BDP-HLD-301

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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240 participants in 2 patient groups, including a placebo group

Bempedoic acid

Experimental group

Description:

Once daily

Treatment:

Drug: Bempedoic Acid Tablet

Placebo

Placebo Comparator group

Description:

Once daily

Treatment:

Drug: Placebo