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
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.
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 →CSPC Ouyi Pharmaceutical Co., Ltd. is the lead sponsor of 30 studies on the registry; 15 are open to participants now.
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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
6.Fully understand the purpose and requirements of the study, voluntarily participate in the clinical trial, and sign a written form.
Exclusion Criteria:
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.
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.
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.
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.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bempedoic Acid Tablet Once daily, oral
Drug: Bempedoic Acid Tablet
Placebo Once daily, oral
Drug: Placebo
bempedoic acid 180 mg tablet taken orally, once daily. Participants in the experiment remain on ongoing lipid-modifying therapy
Matching placebo tablet taken orally, once daily. Participants in the experiment remain on ongoing lipid-modifying therapy
Percentage change from baseline in LDL-C levels at Week 12
Time frame: Baseline, Week 12
Proportion of participants achieving LDL-C target
Time frame: Baseline, Week 12
Percentage change from baseline in non-HDL-C、ApoB、TC、hs-CRP levels at Week 12
Time frame: Baseline, Week 12
Adverse events (AEs) and serious adverse events (SAEs) during the study
Time frame: Baseline, Week 13
No study locations are listed for this record.
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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Studies of the drug tested here: Bempedoic acid
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