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New pill could help millions with stubborn high cholesterol

NCT ID NCT07623915

Disease control Sponsor: CSPC Ouyi Pharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tests bempedoic acid, a daily pill, in 222 adults with high cholesterol that statins alone can't control. Participants take the drug or a placebo for 12 weeks while staying on their usual cholesterol meds. The main goal is to see how much LDL ('bad') cholesterol drops. If successful, it could provide a new option for people at risk of heart disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
bempedoic acid
What this could lead to
If it works, this could offer a new daily pill option for people with high cholesterol that statins alone can't manage.
What could go wrong
This is still a phase 3 trial, so results are not yet known. The drug may not lower cholesterol enough or could have side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 222 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

hyperlipidemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Primary hyperlipidemia

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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