NCT07619131ClinicalTrials.gov

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

RecruitingTaking participants now, according to the registry record.

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In brief

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…

Phase 3600 participants sought152 sites11 countries

Registered in 1 registry

ClinicalTrials.govNCT07619131Open this record at ClinicalTrials.govSynced 2 weeks ago

One study can be registered in several registries. We show it once and link every record we hold.

Trial information is shown as published by the registry, in its original language.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Present: Registered before enrolment beganFirst posted 2026-06-01; recorded start 2026-08-12
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Present: Participants are randomly assignedAllocation is recorded as randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Present: Uses blinding (masking)A masking level is recorded in the record
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 1019 other studies in this databaseCounted from the lead sponsor named in the record (AstraZeneca)
Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database

The record lists 1 condition.
Lead sponsor type recorded as: industry.
Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourSTRONG

A strong methodological design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation20/20
Participants are randomly allocated between arms
Blinding20/20
Quadruple-blind
Control arm15/15
Active-comparator control arm
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type3/10
Surrogate or intermediate endpoint (conservative default)
Multi-centre0/8
Single site, or site count not stated
Data monitoring committee0/7
No data monitoring committee stated
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleMEDIUM

A medium-sized study, international in scope: 600 participants (target), run at 152 sites, across 11 countries.

How this score is built

Enrolment27/40
600 participants (target)
Site count0/25
Site count not stated in the record
Country count0/15
Country count not stated in the record
Planned duration5/10
Planned over about 12 months
Sponsor scale10/10
AstraZeneca has led 1,005 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Summary

Conditions

Hypercholesterolaemia

Eligibility

Eligibility
Sex	All
Ages	18 Years – 130 Years
Healthy volunteers	No

Eligibility as written in the registry

Inclusion Criteria: * 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 screening Exclusion Criteria: * Asian origin. * Statin intolerance * Uncontrolled severe hypertension * Uncontrolled type 2 diabetes mellitus * Inadequately treated hypothyroidism

Eligibility in plain statements

This record's criteria have not been broken into separate statements yet. The registry text above is complete and is the authoritative version.

Study design

Study design
Study type	Interventional
Phase	Phase 3
Allocation	Randomised
Intervention model	FACTORIAL
Primary purpose	TREATMENT
Masking	QUADRUPLE (4)
Enrolment	600 participants sought

Sponsor and collaborators

AstraZeneca Sponsor

Arms and interventions

LaroprovstatACTIVE_COMPARATOR
The patient will receive a daily dose of Laroprovstat
PlaceboPLACEBO_COMPARATOR
The patient will receive a daily dose of Placebo
Laroprovstat/Rosuvastatin dose combination 1EXPERIMENTAL
The patient will receive a daily dose of Laroprovstat/Rosuvastatin 1
Laroprovstat/Rosuvastatin dose combination 2EXPERIMENTAL
The patient will receive a daily dose of Laroprovstat/Rosuvastatin 2
Rosuvastatin dose 1ACTIVE_COMPARATOR
The patient will receive a daily dose of Rosuvastatin 1
Rosuvastatin dose 2ACTIVE_COMPARATOR
The patient will receive a daily dose of Rosuvastatin 2

Interventions

Drug Laroprovstat
daily oral dose of the Laroprovstat
Drug Laroprovstat/Rosuvastatin 1
daily oral dose of the Laroprovstat/Rosuvastatin 1
Drug Laroprovstat/Rosuvastatin 2
daily oral dose of the Laroprovstat/Rosuvastatin 2
Drug Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1
daily oral dose of the Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1
Drug Placebo to match Laroprovstat/Rosuvastatin 2
daily oral dose of the Placebo to match Laroprovstat/Rosuvastatin 2
Drug Placebo to match rosuvastatin
daily oral dose of the Placebo to match Rosuvastatin
Drug Rosuvastatin 1
daily oral dose of the Rosuvastatin 1
Drug Rosuvastatin 2
daily oral dose of the Rosuvastatin 2

Outcome measures

Primary outcome
Relative change in LDL-C at 8 weeks
To compare the effect of treatment with FDC laroprovstat/rosuvastatin 2 versus the following on LDL-C at 8 weeks: * Placebo * Rosuvastatin 2 * Laroprovstat
Time frame 8 weeks
Primary outcome
Relative change in LDL-C at 8 weeks
To compare the effect of treatment with FDC laroprovstat/rosuvastatin 1 versus the following on LDL-C at 8 weeks: * Placebo * Rosuvastatin 1 * Laroprovstat
Time frame 8 weeks
Secondary outcome
Relative change in LDL-C
To compare the effect of treatment with FDC laroprovstat/rosuvastatin 1 versus rosuvastatin 2 alone on LDL-C at 8 weeks
Time frame 8 weeks
Secondary outcome
Relative change in Apo B
To compare the effect of treatment with FDC laroprovstat/rosuvastatin versus the individual components and placebo on apolipoprotein B (Apo B) at 8 weeks
Time frame 8 weeks
Secondary outcome
Relative change in non-HDL-C
To compare the effect of treatment with FDC laroprovstat/rosuvastatin versus the individual components and placebo on non-high-density lipoprotein cholesterol (non-HDL-C) at 8 weeks
Time frame 8 weeks
Secondary outcome
Relative change in total cholesterol
To compare the effect of treatment with FDC laroprovstat/rosuvastatin versus the individual components and placebo on total cholesterol at 8 weeks
Time frame 8 weeks

Dates

Dates
Start date	August 12, 2026 (actual)
Primary completion	July 30, 2027 (estimated)
Completion	July 30, 2027 (estimated)
First posted	June 1, 2026 (actual)
Last updated	September 10, 2026
Results posted	Not stated in the registry record
Status last verified	September 2026

Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.

Locations

12 sites are recruiting

Bulgaria

Bulgaria
Facility	City	Status
Research Site	Burgas	Not yet recruiting
Research Site	Plovdiv	Not yet recruiting
Research Site	Razgrad	Not yet recruiting
Research Site	Sevlievo	Not yet recruiting
Research Site	Sofia	Not yet recruiting
Research Site	Sofia	Not yet recruiting
Research Site	Sofia	Not yet recruiting
Research Site	Varna	Not yet recruiting
Research Site	Veliko Tarnovo	Not yet recruiting

Canada

Canada
Facility	City	State or region	Status
Research Site	Chicoutimi	Quebec	Not yet recruiting
Research Site	Hamilton	Ontario	Recruiting
Research Site	Scarborough Village	Ontario	Recruiting
Research Site	Sherbrooke	Quebec	Recruiting
Research Site	Stouffville	Ontario	Recruiting
Research Site	Victoriaville	Quebec	Not yet recruiting

Denmark

Denmark
Facility	City	Status
Research Site	Aarhus	Not yet recruiting
Research Site	Copenhagen	Not yet recruiting
Research Site	Gandrup	Not yet recruiting
Research Site	Herlev	Not yet recruiting
Research Site	Herning	Not yet recruiting
Research Site	Svendborg	Not yet recruiting
Research Site	Vejle	Not yet recruiting
Research Site	Viborg	Not yet recruiting

Germany

Germany
Facility	City	Status
Research Site	Ahrensburg	Not yet recruiting
Research Site	Berlin	Not yet recruiting
Research Site	Bochum	Not yet recruiting
Research Site	Gladbeck	Not yet recruiting
Research Site	Hamburg	Not yet recruiting
Research Site	Hanover	Not yet recruiting
Research Site	Karlsruhe	Not yet recruiting
Research Site	Leipzig	Not yet recruiting
Research Site	Löhne	Not yet recruiting
Research Site	Magdeburg	Not yet recruiting
Research Site	Obertshausen	Not yet recruiting
Research Site	Wiesbaden	Not yet recruiting

Hungary

Hungary
Facility	City	Status
Research Site	Budapest	Not yet recruiting
Research Site	Budapest	Not yet recruiting
Research Site	Budapest	Not yet recruiting
Research Site	Kaposvár	Not yet recruiting
Research Site	Zalaegerszeg	Not yet recruiting

Israel

Israel
Facility	City	Status
Research Site	Haifa	Not yet recruiting
Research Site	Jerusalem	Not yet recruiting
Research Site	Jerusalem	Not yet recruiting
Research Site	Kfar Saba	Not yet recruiting
Research Site	Petah Tikva	Not yet recruiting

Poland

Poland
Facility	City	Status
Research Site	Częstochowa	Not yet recruiting
Research Site	Gdynia	Suspended
Research Site	Katowice	Not yet recruiting
Research Site	Lodz	Not yet recruiting
Research Site	Lodz	Suspended

102 further sites are listed in the registry record.

Study documents

No documents are linked in this registry record.

Changes over time

September 10, 2026
Status changed
Status changed from Not yet recruiting to Recruiting
NOT_YET_RECRUITINGRECRUITING
September 10, 2026
Recruitment opened
Recruitment opened
NOT_YET_RECRUITINGRECRUITING
September 10, 2026
Site added
152 sites added (152 total)
0152

Registry: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT07619131

Categories

Registered in 1 registry

Interested in this study?

How this study is set up

Summary

Conditions

Eligibility

Eligibility as written in the registry

Eligibility in plain statements

Study design

Sponsor and collaborators

Arms and interventions

Interventions

Outcome measures

Dates

Locations

Bulgaria

Canada

Denmark

Germany

Hungary

Israel

Poland

Study documents

Changes over time