ClinicalTrials.gg
Not yet recruitingNCT07623915Updated Jun 3, 2026

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

A Phase 3 interventional study of Bempedoic Acid Tablet and Placebo in Primary Hyperlipidemia, sponsored by CSPC Ouyi Pharmaceutical Co., Ltd.. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-03.

Sponsored by CSPC Ouyi Pharmaceutical Co., Ltd. (part of CSPC Pharmaceutical Group Limited) · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
222
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Primary Hyperlipidemia

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03

In context

Hyperlipidemias

861 studies on the registry are indexed under Hyperlipidemias; 110 are open to participants now.

This study's planned enrollment of 222 is above the median of 88 across 735 interventional studies indexed under Hyperlipidemias.

Browse Hyperlipidemias studies →

Lead sponsor

CSPC Ouyi Pharmaceutical Co., Ltd. is the lead sponsor of 30 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

1. 18 years and older. 2. 18.5 kg/m2 ≤ (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 form.

Exclusion criteria

Exclusion Criteria:

  1. Known allergy to any component of the drug or its 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
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
222 participants (estimated)

Study arms

  • Experimental
    Bempedoic Acid Tablet

    Bempedoic Acid Tablet Once daily, oral

    Drug: Bempedoic Acid Tablet

  • Placebo comparator
    Placebo

    Placebo Once daily, oral

    Drug: Placebo

Interventions

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

  • DrugPlacebo

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

06

What researchers measure

Primary outcomes

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

    Time frame: Baseline, Week 12

Secondary outcomes

  1. Proportion of participants achieving LDL-C target

    Time frame: Baseline, Week 12

  2. Percentage change from baseline in non-HDL-C、ApoB、TC、hs-CRP levels at Week 12

    Time frame: Baseline, Week 12

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

    Time frame: Baseline, Week 13

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07623915
Responsible party
Sponsor
First posted
Jun 3, 2026
Start date
Jun 12, 2026 (estimated)
Primary completion
Jun 30, 2027 (estimated)
Completion
Aug 28, 2027 (estimated)
Last update
Jun 3, 2026

Study contacts

Clinical Trials Information Group officer
Contact
ctr-contact@cspc.cn
86-0311-69085587

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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