HypercholesterolemiaPhase 3ROZELNCT04669041
A Study to Evaluate the Efficacy and the Safety of Single Pill Combination (SPC) Ezetimibe/Rosuvastatin in Chinese Adult Patients With Primary Hypercholesterolemia Not Adequately Controlled on Statin Therapy
A Phase 3 study testing Rosuvastatin, SPC ezetimibe/rosuvastatin and Rosuvastatin active capsule in people with Hypercholesterolemia, run by Sanofi at 40 sites in China.
Trial summary
Primary Objective: To demonstrate the superiority of the single pill combination (SPC) ezetimibe 10 mg/rosuvastatin 10 mg (E10/R10) compared to rosuvastatin 10 mg (R10), in the reduction of low density lipoprotein cholesterol (LDL-C) after 8 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Rosuvastatin, SPC ezetimibe/rosuvastatin and Rosuvastatin active capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 305 participants
- Where
- 40 sitesChina
- Study dates
- 8 Dec 2020to 15 Jun 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- 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.
Who cannot join
- 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.
Show all 43Show fewer
- 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.
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
China40 sites
Investigational Site Number :1560033
Baotou, 014010
Investigational Site Number :1560001
Beijing, 100029
Investigational Site Number :1560068
Beijing, 100050
Investigational Site Number :1560021
Beijing, 101200
Investigational Site Number :1560025
Bengbu
Investigational Site Number :1560045
Changchun, 130021
Investigational Site Number :1560067
Changchun, 130033
Investigational Site Number :1560052
Changsha, 410013
Investigational Site Number :1560041
Chengdu, 610041
Investigational Site Number :1560060
Chongqing, 400013
Investigational Site Number :1560015
Dalian, 116033
Investigational Site Number :1560029
Haikou, 570311
Investigational Site Number :1560006
Hohhot, 010017
Investigational Site Number :1560007
Hohhot, 010050
Investigational Site Number :1560014
Jilin City, 132011
Investigational Site Number :1560020
Jinan, 250013
Investigational Site Number :1560061
Lishui, 323000
Investigational Site Number :1560071
Liuzhou, 545006
Investigational Site Number :1560066
Nanjing, 210011
Investigational Site Number :1560055
Nanning, 530031
Investigational Site Number :1560027
Shanghai, 200120
Investigational Site Number :1560034
Shenyang, 110016
Investigational Site Number :1560010
Siping, 136000
Investigational Site Number :1560002
Tianjin, 300121
Investigational Site Number :1560053
Tianjin, 300140
Investigational Site Number :1560047
Wuhan, 430022
Investigational Site Number :1560009
Wuhan, 430033
Investigational Site Number :1560035
Wuhan, 430080
Investigational Site Number :1560022
Xi'an, 710061
Investigational Site Number :1560070
Xi'an, 710068
Investigational Site Number :1560003
Xuzhou, 221002
Investigational Site Number :1560065
Yangzhou, 225001
Investigational Site Number :1560057
Yanji, 133000
Investigational Site Number :1560064
Yinchuan, 750004
Investigational Site Number :1560019
Yueyang, 414000
Investigational Site Number :1560062
Yuncheng, 044000
Investigational Site Number :1560005
Zhanjiang, 524001
Investigational Site Number :1560011
Zhenjiang, 212001
Investigational Site Number :1560063
Zhuzhou, 412007
Investigational Site Number :1560037
Zibo, 255036
About this study
Official title: A Randomized Double-blinded, Double Dummy, Active-controlled, Parallel Design, Phase 3 Clinical Trial to Evaluate the Efficacy and the Safety of Single Pill Combination (SPC) Ezetimibe/Rosuvastatin in Chinese Adult Patients With Primary Hypercholesterolemia, Not Adequately Controlled on Statin Therapy
Primary Objective:
To demonstrate the superiority of the single pill combination (SPC) ezetimibe 10 mg/rosuvastatin 10 mg (E10/R10) compared to rosuvastatin 10 mg (R10), in the reduction of low density lipoprotein cholesterol (LDL-C) after 8 weeks.
Secondary Objectives:
- To evaluate the proportion of patients who attain their LDL-C goal.
- To evaluate the effect of SPC (E10/R10) compared to rosuvastatin 10 mg (R10) in reduction of LDL-C at Week 4.
- To evaluate the effect of SPC (E10/R10) compared to R10 on other lipid parameters at Week 4 and Week 8.
- To evaluate the safety of SPC (E10/R10) and R10.
Read the detailed description
Study duration per participants is approximatively 16 weeks.
- Conditions
- Hypercholesterolemia
- Being tested
- Rosuvastatin, SPC ezetimibe/rosuvastatin, Rosuvastatin active capsule, Placebo
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Also called Crestor®
Pharmaceutical form:Tablet Route of administration: Oral
SPC ezetimibe/rosuvastatinDrug
Pharmaceutical form:Tablet Route of administration: Oral
Rosuvastatin active capsuleDrug
Pharmaceutical form:Capsule Route of administration: Oral
PlaceboDrug
Pharmaceutical form:Tablet Route of administration: Oral
PlaceboDrug
Pharmaceutical form:Capsule Route of administration: Oral
| Study group | Role | What they receive |
|---|---|---|
| Single pill combination (SPC) | Experimental | Once daily rosuvastatin 10 mg for 4 weeks, then once daily SPC ezetimibe 10 mg /rosuvastatin 10 mg (E10/R10) for 8 weeks Receives: Drug: Rosuvastatin; Drug: SPC ezetimibe/rosuvastatin; Drug: Placebo |
| Rosuvastatin | Active comparator | Once daily rosuvastatin 10 mg for 4 weeks, then once daily rosuvastatin 10 mg (R10) for 8 weeks Receives: Drug: Rosuvastatin; Drug: Rosuvastatin active capsule; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in measured LDL-C from baseline (the last available measured LDL-C value obtained up to randomization) to Week 8
The percent change from baseline in measured LDL-C at Week 8 will be analyzed in the modified intent-to-treat (mITT) population using a mixed effect model with repeated measures (MMRM) approach.
Measured: Baseline to Week 8
Secondary outcomes (9)
Proportion of patients who attain lipid goal (measured LDL-C <2.6 mmol/L [100 mg/dL]) at Week 8
Measured: Week 8
Percent change in measured LDL-C plasma level from baseline to Week 4
Measured: Baseline to Week 4
Percent change in total cholesterol (TC) from baseline to Week 8
Measured: Baseline to Week 8
Percent change in TC from baseline to Week 4
Measured: Baseline to Week 4
Percent change in triglyceride (TG) serum levels from baseline to Week 8
Measured: Baseline to Week 8
Percent change in TG serum levels from baseline to Week 4
Measured: Baseline to Week 4
Percent change in high density lipoprotein cholesterol (HDL-C) from baseline to Week 8
Measured: Baseline to Week 8
Percent change in HDL-C from baseline to Week 4
Measured: Baseline to Week 4
Number of patients with adverse events (AEs)
Measured: Up to 16 weeks (±3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start8 Dec 2020
- Primary completion15 Jun 2022
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by SanofiThe 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, Care provider, Investigator
- Enrolment
- 305 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04669041
- Sponsor's protocol ID
- LPS16135
- Other IDs
- U1111-1227-3920
- Acronym
- ROZEL
- Status last verified
- Sep 2025
- First submitted
- 8 Dec 2020
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Publications
Su Q, Liu Y, Zhang G, Xu L, Wang M, Mei S, Garon G, Wu Y, Lv Q, Ma C. Efficacy and Safety of Single-Pill Combination of Rosuvastatin and Ezetimibe in Chinese Patients with Primary Hypercholesterolemia Inadequately Controlled by Statin Treatment (ROZEL): A Randomized, Double-Blind, Double Dummy, Active-Controlled Phase 3 Clinical Trial. Adv Ther. 2023 Dec;40(12):5285-5299. doi: 10.1007/s12325-023-02666-z. Epub 2023 Sep 28.
PubMed 37770770
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-blinded, Double Dummy, Active-controlled, Parallel Design, Phase 3 Clinical Trial to Evaluate the Efficacy and the Safety of Single Pill Combination (SPC) Ezetimibe/Rosuvastatin in Chinese Adult Patients With Primary Hypercholesterolemia, Not Adequately Controlled on Statin Therapy
- ClinicalTrials.gov ID
- NCT04669041
- Acronym / sponsor ID
- ROZEL / LPS16135
- Conditions
- Hypercholesterolemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 305 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 8 Dec 2020 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 16 Dec 2020 (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.
Primary Objective:
To demonstrate the superiority of the single pill combination (SPC) ezetimibe 10 mg/rosuvastatin 10 mg (E10/R10) compared to rosuvastatin 10 mg (R10), in the reduction of low density lipoprotein cholesterol (LDL-C) after 8 weeks.
Secondary Objectives:
- To evaluate the proportion of patients who attain their LDL-C goal.
- To evaluate the effect of SPC (E10/R10) compared to rosuvastatin 10 mg (R10) in reduction of LDL-C at Week 4.
- To evaluate the effect of SPC (E10/R10) compared to R10 on other lipid parameters at Week 4 and Week 8.
- To evaluate the safety of SPC (E10/R10) and R10.
Detailed description
Study duration per participants is approximatively 16 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single pill combination (SPC) | Experimental | Drug: Rosuvastatin, Drug: SPC ezetimibe/rosuvastatin, Drug: PlaceboOnce daily rosuvastatin 10 mg for 4 weeks, then once daily SPC ezetimibe 10 mg /rosuvastatin 10 mg (E10/R10) for 8 weeks |
| Rosuvastatin | Active comparator | Drug: Rosuvastatin, Drug: Rosuvastatin active capsule, Drug: PlaceboOnce daily rosuvastatin 10 mg for 4 weeks, then once daily rosuvastatin 10 mg (R10) for 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (43 listed)
- 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.
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 |
|---|---|---|
| RosuvastatinAlso: Crestor®Pharmaceutical form:Tablet Route of administration: Oral | Drug | Rosuvastatin, Single pill combination (SPC) |
| SPC ezetimibe/rosuvastatinPharmaceutical form:Tablet Route of administration: Oral | Drug | Single pill combination (SPC) |
| Rosuvastatin active capsulePharmaceutical form:Capsule Route of administration: Oral | Drug | Rosuvastatin |
| PlaceboPharmaceutical form:Tablet Route of administration: Oral | Drug | Rosuvastatin |
| PlaceboPharmaceutical form:Capsule Route of administration: Oral | Drug | Single pill combination (SPC) |
Primary outcome
Percent change in measured LDL-C from baseline (the last available measured LDL-C value obtained up to randomization) to Week 8
Time frame: Baseline to Week 8
The percent change from baseline in measured LDL-C at Week 8 will be analyzed in the modified intent-to-treat (mITT) population using a mixed effect model with repeated measures (MMRM) approach.
9 secondary outcomes
Proportion of patients who attain lipid goal (measured LDL-C <2.6 mmol/L [100 mg/dL]) at Week 8
Time frame: Week 8
Percent change in measured LDL-C plasma level from baseline to Week 4
Time frame: Baseline to Week 4
Percent change in total cholesterol (TC) from baseline to Week 8
Time frame: Baseline to Week 8
Percent change in TC from baseline to Week 4
Time frame: Baseline to Week 4
Percent change in triglyceride (TG) serum levels from baseline to Week 8
Time frame: Baseline to Week 8
Percent change in TG serum levels from baseline to Week 4
Time frame: Baseline to Week 4
Percent change in high density lipoprotein cholesterol (HDL-C) from baseline to Week 8
Time frame: Baseline to Week 8
Percent change in HDL-C from baseline to Week 4
Time frame: Baseline to Week 4
Number of patients with adverse events (AEs)
Time frame: Up to 16 weeks (±3 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Derived from this study: PubMed 37770770Su Q, Liu Y, Zhang G, Xu L, Wang M, Mei S, Garon G, Wu Y, Lv Q, Ma C. Efficacy and Safety of Single-Pill Combination of Rosuvastatin and Ezetimibe in Chinese Patients with Primary Hypercholesterolemia Inadequately Controlled by Statin Treatment (ROZEL): A Randomized, Double-Blind, Double Dummy, Active-Controlled Phase 3 Clinical Trial. Adv Ther. 2023 Dec;40(12):5285-5299. doi: 10.1007/s12325-023-02666-z. Epub 2023 Sep 28.
- LPS16135 Plain Language Results SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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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. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rosuvastatin, SPC ezetimibe/rosuvastatin and Rosuvastatin active capsule in people with Hypercholesterolemia, run by Sanofi at 40 sites in China.
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 5 inclusion and 43 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: finished, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in measured LDL-C from baseline (the last available measured LDL-C value obtained up to randomization) to Week 8 (time frame: Baseline to Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04669041, which also lists 1 linked publication.
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 22 Sep 2025.