Primary HyperlipidemiaPhase 3NCT07623915
A Clinical Study to Evaluate the Efficacy and Safety of Bempedoic Acid
A Phase 3 study testing Bempedoic Acid Tablet in people with Primary Hyperlipidemia, run by CSPC Ouyi Pharmaceutical Co., Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Hyperlipidemia
- What is being tested?
- Bempedoic Acid Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 222 participants
- Where
- No sites listed yet
- Study dates
- 12 Jun 2026to 28 Aug 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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).
- 6.Fully understand the purpose and requirements of the study, voluntarily participate in the clinical trial, and sign a written informed consent form.
Who cannot join
- 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
Show all 9Show fewer
- Severe cardiovascular or cerebrovascular events in the past 3 months
- History of nephrotic syndrome or glomerulonephritis or severe renal dysfunction.
- Liver disease or dysfunction
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Primary Hyperlipidemia
- Being tested
- Bempedoic Acid Tablet, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bempedoic Acid TabletDrug
bempedoic acid 180 mg tablet taken orally, once daily. Participants in the experiment remain on ongoing lipid-modifying therapy
PlaceboDrug
Matching placebo tablet taken orally, once daily. Participants in the experiment remain on ongoing lipid-modifying therapy
| Study group | Role | What they receive |
|---|---|---|
| Bempedoic Acid Tablet | Experimental | Bempedoic Acid Tablet Once daily, oral Receives: Drug: Bempedoic Acid Tablet |
| Placebo | Placebo comparator | Placebo Once daily, oral Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change from baseline in LDL-C levels at Week 12
Measured: Baseline, Week 12
Secondary outcomes (3)
Proportion of participants achieving LDL-C target
Measured: Baseline, Week 12
Percentage change from baseline in non-HDL-C、ApoB、TC、hs-CRP levels at Week 12
Measured: Baseline, Week 12
Adverse events (AEs) and serious adverse events (SAEs) during the study
Measured: Baseline, Week 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start12 Jun 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion28 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary HyperlipidemiaStudies of the same condition, open and under way.
- More trials run by CSPC Ouyi Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 222 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07623915
- Sponsor's protocol ID
- SYH9117-002
- Status last verified
- May 2026
- First submitted
- 29 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07623915
- Acronym / sponsor ID
- SYH9117-002
- Conditions
- Primary Hyperlipidemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 222 participants (estimated)
- Lead sponsor
- CSPC Ouyi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Jun 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 28 Aug 2027 (estimated)
- First posted
- 3 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bempedoic Acid Tablet | Experimental | Drug: Bempedoic Acid TabletBempedoic Acid Tablet Once daily, oral |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo Once daily, oral |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
- 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).
- 6.Fully understand the purpose and requirements of the study, voluntarily participate in the clinical trial, and sign a written informed consent form.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bempedoic Acid Tabletbempedoic acid 180 mg tablet taken orally, once daily. Participants in the experiment remain on ongoing lipid-modifying therapy | Drug | Bempedoic Acid Tablet |
| PlaceboMatching placebo tablet taken orally, once daily. Participants in the experiment remain on ongoing lipid-modifying therapy | Drug | Placebo |
Primary outcome
Percentage change from baseline in LDL-C levels at Week 12
Time frame: Baseline, Week 12
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bempedoic Acid Tablet in people with Primary Hyperlipidemia, run by CSPC Ouyi Pharmaceutical Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Information Group officer (86-0311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change from baseline in LDL-C levels at Week 12 (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.