Testing Laroprovstat against a placebo for hypercholesterolaemia
Official title: A Phase III Study to Assess the Effect of FDC Laroprovstat/Rosuvastatin Compared With Laroprovstat, Rosuvastatin and Placebo on LDL-C in LLT-naïve Patients.
A Phase III Randomised, Double-Blind, Factorial Design Study to Assess the Effect of Fixed Dose Combination Laroprovstat/Rosuvastatin Compared With Laroprovstat, Rosuvastatin, and Placebo on Low-Density Lipoprotein Cholesterol in Lipid-Lowering Treatment-Naïve Patients
Interventions
Laroprovstat
daily oral dose of the Laroprovstat
Rosuvastatin 1
daily oral dose of the Rosuvastatin 1
Rosuvastatin 2
daily oral dose of the Rosuvastatin 2
Laroprovstat/Rosuvastatin 1
daily oral dose of the Laroprovstat/Rosuvastatin 1
Placebo to match rosuvastatin
daily oral dose of the Placebo to match Rosuvastatin
Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1
daily oral dose of the Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1
Laroprovstat/Rosuvastatin 2
daily oral dose of the Laroprovstat/Rosuvastatin 2
Placebo to match Laroprovstat/Rosuvastatin 2
daily oral dose of the Placebo to match Laroprovstat/Rosuvastatin 2
Canadian Sites (6)
Research Site
Hamilton, Ontario, Canada
Research Site
Scarborough Village, Ontario, Canada
Research Site
Stouffville, Ontario, Canada
Research Site
Chicoutimi, Quebec, Canada
Research Site
Sherbrooke, Quebec, Canada
Research Site
Victoriaville, Quebec, Canada
Eligibility Criteria
See who this study is looking for8 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Participant must be ≥ 18 years of age
- +Participants with no clinical history of atherosclerotic cardiovascular disease (ASCVD) and a 10-year ASCVD risk estimated as low
- +Participants who have not received any LLT in the 3 months prior to screeningScreeningThe checks done before joining, to see whether a study fits.Read more →
Exclusion
- −Asian origin.
- −Statin intolerance
- −Uncontrolled severe hypertension
- −Uncontrolled type 2 diabetes mellitus
- −Inadequately treated hypothyroidism
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
What is being given or done in this study: Laroprovstat, Rosuvastatin 1, Rosuvastatin 2, Laroprovstat/Rosuvastatin 1, and 4 more.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
One group receives an existing treatment, so the two can be compared.
There are 6 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists an age range of 18 years to 130 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 600 people.
The study is currently expected to finish around July 2027.
The main measurement is taken over: 8 weeks.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Relative change in LDL-C at 8 weeks — measured over 8 weeks.
Relative change in LDL-C at 8 weeks — measured over 8 weeks.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07619131 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About LaroprovstatDrug
daily oral dose of the Laroprovstat
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Rosuvastatin 1Drug
daily oral dose of the Rosuvastatin 1
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Rosuvastatin 2Drug
daily oral dose of the Rosuvastatin 2
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Laroprovstat/Rosuvastatin 1Drug
daily oral dose of the Laroprovstat/Rosuvastatin 1
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Placebo to match rosuvastatinDrug
daily oral dose of the Placebo to match Rosuvastatin
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1Drug
daily oral dose of the Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Laroprovstat/Rosuvastatin 2Drug
daily oral dose of the Laroprovstat/Rosuvastatin 2
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Placebo to match Laroprovstat/Rosuvastatin 2Drug
daily oral dose of the Placebo to match Laroprovstat/Rosuvastatin 2
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 130 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 130 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 8 weeks.
The study as a whole is currently expected to finish around 2027-07-30.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 600 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 12 locations, including: Hamilton, Ontario, Canada; Scarborough Village, Ontario, Canada; Stouffville, Ontario, Canada; Chicoutimi, Quebec, Canada; Sherbrooke, Quebec, Canada; Victoriaville, Quebec, Canada, and 6 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
This is a study to evaluate the effect on LDL-C and the safety and tolerability of FDC laroprovstat/rosuvastatin in LLT-naïve patients. Laroprovstat is a small molecule that reduces the amount of LDL-C in the blood. Laroprovstat and FDC laroprovstat/rosuvastatin are being developed for the treatment of hypercholesterolaemia.
Other Sites (7)
Research Site
Flint, Michigan, United States
Research Site
Troy, Michigan, United States
Research Site
Astoria, New York, United States
Research Site
Brooklyn, New York, United States
Research Site
Brooklyn, New York, United States
Research Site
The Bronx, New York, United States
Research Site
Redmond, Washington, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.