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

NCT07623915 | Not Yet Recruiting Phase 3

• 1 other identifier: SYH9117-002
• Study Type: interventional
• Target: 222
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Primary Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

• Percentage change from baseline in LDL-C levels at Week 12

  Baseline, Week 12

Secondary Outcomes (3)

• 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

• Adverse events (AEs) and serious adverse events (SAEs) during the study

  Baseline, Week 13

Study Arms (2)

Bempedoic Acid Tablet

EXPERIMENTAL

Bempedoic Acid Tablet Once daily, oral

Drug: Bempedoic Acid Tablet

Placebo

PLACEBO COMPARATOR

Placebo Once daily, oral

Drug: Placebo

Interventions

Bempedoic Acid Tablet DRUG

bempedoic acid 180 mg tablet taken orally, once daily. Participants in the experiment remain on ongoing lipid-modifying therapy

Bempedoic Acid Tablet

Placebo DRUG

Matching placebo tablet taken orally, once daily. Participants in the experiment remain on ongoing lipid-modifying therapy

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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
• For participants with high risk of ASCVD: LDL-C ≥ 2.6 mmol/L (or 100 mg/dL);
• 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).
• Fully understand the purpose and requirements of the study, voluntarily participate in the clinical trial, and sign a written informed consent form.

You may not qualify if:

• 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.
• Diagnosis with HoFH.
• History of tendon diseases or tendon ruptures before the screening.
• Severe, uncontrolled concomitant conditions that may affect drug absorption or have a significant impact on lipid level.
• Hyperthyroidism or uncontrolled hypothyroidism
• Uncontrolled hypertension
• Severe cardiovascular or cerebrovascular events in the past 3 months
• History of nephrotic syndrome or glomerulonephritis or severe renal dysfunction.
• Liver disease or dysfunction

Sponsors & Collaborators

• CSPC Ouyi Pharmaceutical Co., Ltd.: lead

MeSH Terms

Interventions

8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

86-0311-69085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: June 3, 2026
• Study Start: June 12, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): August 28, 2027
• Last Updated: June 3, 2026

Record last verified: 2026-05