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

May 26, 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

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • 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

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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
Intervention / Treatment
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

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

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

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 (Estimated)

September 15, 2026

Primary Completion (Estimated)

May 28, 2027

Study Completion (Estimated)

May 28, 2027

Study Registration Dates

First Submitted

May 26, 2026

First Submitted That Met QC Criteria

May 26, 2026

First Posted (Actual)

June 1, 2026

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 26, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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