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

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Bempedoic Acid in Patients With Hyperlipidemia Not Adequately Controlled by Statins

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Primary Hyperlipidemia
• Intervention / Treatment: Drug: Bempedoic Acid Tablet; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 222
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Clinical Trials Information Group officer; Phone Number: 86-0311-69085587; Email: ctr-contact@cspc.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bempedoic Acid Tablet; Bempedoic Acid Tablet Once daily, oral	Drug: Bempedoic Acid Tablet; bempedoic acid 180 mg tablet taken orally, once daily. Participants in the experiment remain on ongoing lipid-modifying therapy
Placebo Comparator: Placebo; Placebo Once daily, oral	Drug: Placebo; Matching placebo tablet taken orally, once daily. Participants in the experiment remain on ongoing lipid-modifying therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage change from baseline in LDL-C levels at Week 12	Baseline, Week 12

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse events (AEs) and serious adverse events (SAEs) during the study	Baseline, Week 13
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

Collaborators and Investigators

• Sponsor: CSPC Ouyi Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): June 12, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): August 28, 2027

Study Registration Dates

• First Submitted: May 29, 2026
• First Submitted That Met QC Criteria: May 29, 2026
• First Posted (Actual): June 3, 2026

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid
• Other Study ID Numbers: SYH9117-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No