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

Phase 3

Recruiting

• Conditions: Primary Hyperlipidemia
• Interventions: Drug: Bempedoic Acid Tablet; Drug: Placebo

• Registration Number: NCT06780410
• Lead Sponsor: Gan & Lee Pharmaceuticals.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-12-20
• Status Verified: 2025-01
• Study First Submitted: 2025-01-13
• Study First Submitted QC: 2025-01-13
• Last Update Submitted: 2025-01-13
• Study First Posted: 2025-01-17
• Last Update Posted: 2025-01-17
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bempedoic acid	Bempedoic Acid Tablet	Once daily
Placebo	Placebo	Once daily

Primary Outcome Measures

Name	Time	Method
Percentage change from baseline in LDL-C levels at Week 12	Baseline, Week 12

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Site 01; 🇨🇳 Beijing, China