A Phase III Study to Assess the Effect of FDC Laroprovstat/Rosuvastatin Compared With Rosuvastatin on LDL-C in Patients With Hypercholesterolaemia

October 1, 2026 updated by: AstraZeneca

A Phase III Randomised, Double-Blind, Parallel-Group Study to Assess the Effect of Fixed Dose Combination Laroprovstat/Rosuvastatin Compared With Rosuvastatin on Low-Density Lipoprotein Cholesterol in Patients With Hypercholesterolaemia

The purpose of this study is to evaluate the effect on low-density lipoprotein-cholesterol (LDL-C) and the safety and tolerability of a fixed dose combination (FDC) of laroprovstat/rosuvastatin versus rosuvastatin alone in patients with hypercholesterolaemia with either a history of a clinical atherosclerotic cardiovascular disease (ASCVD) event or at increased risk for a first clinical ASCVD event.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
      • Burwood, Australia, 2134
        • Not yet recruiting
        • Research Site
      • Hope Island, Australia, 4212
        • Recruiting
        • Research Site
      • Hoppers Crossing, Australia, 3029
        • Not yet recruiting
        • Research Site
      • Woolloongabba, Australia, 4102
        • Recruiting
        • Research Site
  • Canada
    • Ontario
      • Cambridge, Ontario, Canada, N1R 6V6
        • Suspended
        • Research Site
      • Guelph, Ontario, Canada, N1H 1B1
        • Recruiting
        • Research Site
      • Mississauga, Ontario, Canada, L5K2L3
        • Recruiting
        • Research Site
      • North York, Ontario, Canada, M9N 1W4
        • Recruiting
        • Research Site
      • Stoney Creek, Ontario, Canada, L8J 3W2
        • Recruiting
        • Research Site
      • Toronto, Ontario, Canada, M6G 1M2
        • Recruiting
        • Research Site
  • Germany
      • Berlin, Germany, 10117
        • Not yet recruiting
        • Research Site
      • Essen, Germany, 45355
        • Not yet recruiting
        • Research Site
      • Frankfurt, Germany, 60596
        • Not yet recruiting
        • Research Site
      • Freiburg im Breisgau, Germany, 79106
        • Not yet recruiting
        • Research Site
      • Hanover, Germany, 30159
        • Not yet recruiting
        • Research Site
      • Kaiserslautern, Germany, 67655
        • Not yet recruiting
        • Research Site
      • Leipzig, Germany, 04103
        • Not yet recruiting
        • Research Site
      • Munich, Germany, 80809
        • Not yet recruiting
        • Research Site
      • Nuremberg, Germany, 90402
        • Not yet recruiting
        • Research Site
  • United States
    • Arizona
      • Sun City West, Arizona, United States, 85375
        • Recruiting
        • Research Site
    • California
      • Gardena, California, United States, 90247
        • Not yet recruiting
        • Research Site
      • Lomita, California, United States, 90717
        • Not yet recruiting
        • Research Site
      • Pomona, California, United States, 91768
        • Recruiting
        • Research Site
      • Sacramento, California, United States, 95821
        • Not yet recruiting
        • Research Site
    • Florida
      • Jacksonville, Florida, United States, 32216
        • Not yet recruiting
        • Research Site
      • Miami Lakes, Florida, United States, 33016
        • Recruiting
        • Research Site
      • Orlando, Florida, United States, 32807
        • Not yet recruiting
        • Research Site
      • Pembroke Pines, Florida, United States, 33029
        • Not yet recruiting
        • Research Site
    • Georgia
      • Conyers, Georgia, United States, 30094
        • Recruiting
        • Research Site
      • Decatur, Georgia, United States, 30030
        • Recruiting
        • Research Site
      • Peachtree Corners, Georgia, United States, 30092
        • Not yet recruiting
        • Research Site
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Not yet recruiting
        • Research Site
      • Indianapolis, Indiana, United States, 46260
        • Withdrawn
        • Research Site
    • Louisiana
      • Zachary, Louisiana, United States, 70791
        • Not yet recruiting
        • Research Site
    • Maryland
      • Beltsville, Maryland, United States, 20705
        • Recruiting
        • Research Site
    • North Carolina
      • Rocky Mount, North Carolina, United States, 27804
        • Not yet recruiting
        • Research Site
      • Statesville, North Carolina, United States, 28625
        • Not yet recruiting
        • Research Site
      • Wilmington, North Carolina, United States, 28401
        • Not yet recruiting
        • Research Site
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Not yet recruiting
        • Research Site
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Not yet recruiting
        • Research Site
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Not yet recruiting
        • Research Site
    • Texas
      • Houston, Texas, United States, 77002
        • Not yet recruiting
        • Research Site
      • Houston, Texas, United States, 77040
        • Recruiting
        • Research Site
      • Mesquite, Texas, United States, 75149
        • Recruiting
        • Research Site
      • Sugar Land, Texas, United States, 77478
        • Recruiting
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 130 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participant must be ≥ 18 years of age
  • Participants must be on a stable dose of all background LLTs
  • The stable statin dose should be judged as their maximally tolerated dose
  • Participants should have either history of a clinical ASCVD event or be at increased risk for a first clinical ASCVD event

Exclusion Criteria:

  • Asian origin
  • Uncontrolled severe hypertension
  • Uncontrolled T2DM
  • Inadequately treated hypothyroidism

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: laroprovstat/rosuvastatin dose 1

Patient will receive a daily dose of laroprovstat/rosuvastatin 1 and a placebo to match rosuvastatin 1
Combination product: laroprovstat/rosuvastatin 1

daily oral dose of the laroprovstat/rosuvastatin 1

Drug: Placebo to match Rosuvastatin

daily oral dose of placebo to match rosuvastatin
Active Comparator: rosuvastatin dose 1

Patient will receive a daily dose of rosuvastatin 1 and placebo to match laroprovstat/rosuvastatin 1
Drug: Placebo to match laroprovstat/rosuvastatin 1,2,3

Daily oral dose of placebo to match FDC laroprovstat/rosuvastatin 1,2,3

Drug: Rosuvastatin 1

daily oral dose of rosuvastatin 1
Experimental: laroprovstat/rosuvastatin dose 2

Patient will receive a daily dose of laroprovstat/rosuvastatin 2 and a placebo to match rosuvastatin 2
Drug: Placebo to match Rosuvastatin

daily oral dose of placebo to match rosuvastatin

Combination product: laroprovstat/rosuvastatin 2

daily oral dose of the laroprovstat/rosuvastatin 2
Active Comparator: rosuvastatin dose 2

Patient will receive a daily dose of rosuvastatin 2 and placebo to match laroprovstat/rosuvastatin 2
Drug: Placebo to match laroprovstat/rosuvastatin 1,2,3

Daily oral dose of placebo to match FDC laroprovstat/rosuvastatin 1,2,3

Drug: Rosuvastatin 2

daily oral dose of rosuvastatin 2
Experimental: laroprovstat/rosuvastatin dose 3

Patient will receive a daily dose of laroprovstat/rosuvastatin 3 and a placebo to match rosuvastatin 3
Drug: Placebo to match Rosuvastatin

daily oral dose of placebo to match rosuvastatin

Combination product: laroprovstat/rosuvastatin 3

daily oral dose of the laroprovstat/rosuvastatin 3
Active Comparator: rosuvastatin dose 3

Patient will receive a daily dose of rosuvastatin 3 and placebo to match laroprovstat/rosuvastatin 3
Drug: Placebo to match laroprovstat/rosuvastatin 1,2,3

Daily oral dose of placebo to match FDC laroprovstat/rosuvastatin 1,2,3

Drug: Rosuvastatin 3

daily oral dose of rosuvastatin 3
Experimental: laroprovstat/rosuvastatin dose 4

Patient will receive a daily dose of laroprovstat/rosuvastatin 4 and a placebo to match rosuvastatin 4
Drug: Placebo to match Rosuvastatin

daily oral dose of placebo to match rosuvastatin

Combination product: laroprovstat/rosuvastatin 4

daily oral dose of the laroprovstat/rosuvastatin 4
Active Comparator: rosuvastatin dose 4

Patient will receive a daily dose of rosuvastatin 4 and placebo to match laroprovstat/rosuvastatin 4
Drug: Placebo to match laroprovstat/rosuvastatin 4

Daily oral dose of placebo to match FDC laroprovstat/rosuvastatin 4

Drug: Rosuvastatin 4

daily oral dose of rosuvastatin 4

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Relative change in LDL-C at 8 weeks
Time Frame: 8 weeks

To compare the effect of treatment with laroprovstat/rosuvastatin versus rosuvastatin on LDL-C at 8 weeks
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Relative change in Apo B at 8 weeks
Time Frame: 8 weeks

To compare the effect of treatment with laroprovstat/rosuvastatin versus rosuvastatin on Apo B at 8 weeks
8 weeks
Relative change in non-HDL-C at 8 weeks
Time Frame: 8 weeks

To compare the effect of treatment with laroprovstat/rosuvastatin versus rosuvastatin on non-HDL-C at 8 weeks
8 weeks
Relative change in total cholesterol at 8 weeks
Time Frame: 8 weeks

To compare the effect of treatment with laroprovstat/rosuvastatin versus rosuvastatin on total cholesterol at 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 10, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 28, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 28, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 26, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 1, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D7961C00001
  • 2026-526258-15-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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