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New combo pill aims to crush stubborn high cholesterol

NCT ID NCT04669041

Disease control Sponsor: Sanofi 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026

Summary

This Phase 3 trial tested whether a single pill combining ezetimibe and rosuvastatin works better than rosuvastatin alone for lowering LDL (bad) cholesterol. The study included 305 Chinese adults whose cholesterol was not well controlled on statin therapy. Participants took either the combo pill or rosuvastatin for 8 weeks to compare LDL reduction and safety.

What this could mean

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

Active substance
ezetimibe and rosuvastatin combination pill
What this could lead to
If it works, this could offer a more effective once-daily pill to help people with high cholesterol reach their LDL goals without taking multiple medications.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. The combination may cause more side effects than rosuvastatin alone, and benefits may not apply to all populations.

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

305 people

The number who actually took part.

Started

Dec 2020

Finished

Jun 2022

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 : * Participant must be at least 18 years of age inclusive, at the time of signing the informed consent. * Patients with primary hypercholesterolemia. * Inclusion criteria in the run-in period: Participants who are not adequately controlled (defined by screening LDL-C \>2.6 mmol/L (100 mg/dL) and ≤4.9 mmol/L (190 mg/dL)with a 10 mg stable daily dose of rosuvastatin, or equipotent statin for 4 weeks prior to the screening visit, without any other lipid modifying therapy (LMT). Inclusion criteria in the randomized double-blind period: Participants who are not adequately controlled based on sample taken at qualifying pre randomization visit, despite stabilized dose of rosuvastatin 10 mg (defined by measured LDL-C ≥2.6 mmol/L (100 mg/dL) and ≤4.9 mmol/L (190 mg/dL). * Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. * Capable of giving signed informed consent. Exclusion criteria: * Homozygous familial hypercholesterolemia (FH) (clinically or previous genotyping). * Patient who has received LDL-C plasmapheresis treatment within 2 months prior to the screening visit, or has plans to receive it during the study. * Recently diagnosed (within 3 months prior to the screening visit) myocardial infarction (MI), unstable angina, myocardial revascularization (percutaneous coronary intervention \[PCI\], coronary artery bypass graft surgery \[CABG\]), transient ischemic attack (TIA), or stroke, carotid revascularization, endovascular procedure or surgical intervention for peripheral vascular disease. * Planned to undergo scheduled PCI, CABG, carotid or peripheral revascularization during the study. * Severe hypertension (treated or untreated) with systolic blood pressure (SBP) \>160 mm Hg or diastolic blood pressure (DBP) \>100 mm Hg at study entry. * History of severe congestive heart failure (New York Heart Association Class IIIb or IV) within the past 12 months. * Presence of any clinically significant uncontrolled endocrine disease known to influence serum lipids or lipoproteins, according to Investigator's medical judgement. * Uncontrolled (as determined by fasting glucose \>180 mg/mL or HbA1c \>9%) or newly diagnosed (within 3 months of study entry) diabetes mellitus at the screening visit. * History of cancer within the past 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer. * Conditions/situations such as: * Patient with a short life expectancy. * Patient with conditions/concomitant diseases making them non-evaluable for the primary efficacy endpoint, according to Investigator's medical judgement. * Requirement for concomitant treatment that could bias primary evaluation, according to Investigator's medical judgement. * Impossibility to meet specific protocol requirements (eg, ability to make study visits). * Patient is the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other study staff or relative thereof directly involved in the conduct of the study. * Patient not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or patients potentially at risk of noncompliance to study procedures. * Known history of hypersensitivity reaction to statins and/or ezetimibe. * Current myopathy. * A history of statin-induced myopathy or rhabdomyolysis. * Current active liver disease including unexplained, persistent elevations of serum transaminases and any serum transaminase elevation exceeding 3 x upper limit of normal (ULN) range at the screening visit. * All contraindications to the active comparator (rosuvastatin) and background therapies or warning/precaution of use (when appropriate) as displayed in the respective National Product Labeling. * Patients not previously instructed on a cholesterol-lowering diet prior to the screening visit. * Use of systemic corticosteroids, unless used as replacement therapy for pituitary/adrenal disease with a stable regimen for at least 6 weeks prior to screening visit. * Use of hormone replacement therapy or oral contraceptives unless regimen has been stable in the past 6 weeks prior to the screening visit and no plans to change the regimen during the study. * Concomitant administration of cyclosporine (at screening and randomization visits). * Human immunodeficiency virus (HIV) patients receiving protease inhibitors (at screening and randomization visits). * Patient who has taken any active investigational drugs (E10/R10) within 1 month or 5 half-lives prior to screening, whichever is longer. * Laboratory findings obtained during the screening visit (V1): * Fasting serum TGs \>400 mg/dL. * Positive serum pregnancy test. * Serum creatine kinase \>3 times ULN. * Thyroid-stimulating hormone (TSH) \< lower limit of normal (LLN) or \> ULN. * Glycated hemoglobin A1c (HbA1c) \>9%. * Estimated glomerular filtration rate \<30 mL/min/1.73 m2. * Alanine aminotransferase or AST \>3 x ULN. * Individuals accommodated in an institution because of regulatory or legal order; prisoners or subjects who are legally institutionalized. * Any technical/administrative reason (eg, patient homeless) that makes it impossible to enroll/randomize the patient in the study. * Alcohol abuse according to Investigator's medical judgement. * Participants are dependent on the Sponsor or Investigator (in conjunction with Section 1.61 of the ICH-GCP Ordinance E6). * Participants are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals. * Any specific situation during study implementation/course that may rise ethics considerations. * Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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Conditions

The condition(s) this trial relates to.

Hypercholesterolemia hyperlipidemia

As listed by the trial registrant

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

Hypercholesterolemia

Contacts and locations

Locations

  • Investigational Site Number :1560001

    Beijing, 100029, China

  • Investigational Site Number :1560002

    Tianjin, 300121, China

  • Investigational Site Number :1560003

    Xuzhou, 221002, China

  • Investigational Site Number :1560005

    Zhanjiang, 524001, China

  • Investigational Site Number :1560006

    Hohhot, 010017, China

  • Investigational Site Number :1560007

    Hohhot, 010050, China

  • Investigational Site Number :1560009

    Wuhan, 430033, China

  • Investigational Site Number :1560010

    Siping, 136000, China

  • Investigational Site Number :1560011

    Zhenjiang, 212001, China

  • Investigational Site Number :1560014

    Jilin City, 132011, China

  • Investigational Site Number :1560015

    Dalian, 116033, China

  • Investigational Site Number :1560019

    Yueyang, 414000, China

  • Investigational Site Number :1560020

    Jinan, 250013, China

  • Investigational Site Number :1560021

    Beijing, 101200, China

  • Investigational Site Number :1560022

    Xi'an, 710061, China

  • Investigational Site Number :1560025

    Bengbu, China

  • Investigational Site Number :1560027

    Shanghai, 200120, China

  • Investigational Site Number :1560029

    Haikou, 570311, China

  • Investigational Site Number :1560033

    Baotou, 014010, China

  • Investigational Site Number :1560034

    Shenyang, 110016, China

  • Investigational Site Number :1560035

    Wuhan, 430080, China

  • Investigational Site Number :1560037

    Zibo, 255036, China

  • Investigational Site Number :1560041

    Chengdu, 610041, China

  • Investigational Site Number :1560045

    Changchun, 130021, China

  • Investigational Site Number :1560047

    Wuhan, 430022, China

  • Investigational Site Number :1560052

    Changsha, 410013, China

  • Investigational Site Number :1560053

    Tianjin, 300140, China

  • Investigational Site Number :1560055

    Nanning, 530031, China

  • Investigational Site Number :1560057

    Yanji, 133000, China

  • Investigational Site Number :1560060

    Chongqing, 400013, China

  • Investigational Site Number :1560061

    Lishui, 323000, China

  • Investigational Site Number :1560062

    Yuncheng, 044000, China

  • Investigational Site Number :1560063

    Zhuzhou, 412007, China

  • Investigational Site Number :1560064

    Yinchuan, 750004, China

  • Investigational Site Number :1560065

    Yangzhou, 225001, China

  • Investigational Site Number :1560066

    Nanjing, 210011, China

  • Investigational Site Number :1560067

    Changchun, 130033, China

  • Investigational Site Number :1560068

    Beijing, 100050, China

  • Investigational Site Number :1560070

    Xi'an, 710068, China

  • Investigational Site Number :1560071

    Liuzhou, 545006, China

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