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

November 5, 2026 updated by: AstraZeneca

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

The purpose of this study is to evaluate the effect on LDL-C and the safety and tolerability of FDC laroprovstat/rosuvastatin in LLT-naïve patients with hypercholesterolaemia. Laroprovstat and FDC laroprovstat/rosuvastatin are being developed for the treatment of hypercholesterolaemia.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

204

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

Study Locations

  • China
      • Beijing, China, 102218
        • Research Site
      • Chifeng, China, 024000
        • Research Site
      • Guangzhou, China, 510220
        • Research Site
      • Hangzhou, China, 310009
        • Research Site
      • Ha’erbin, China, 150001
        • Research Site
      • Hefei, China, 230601
        • Research Site
      • Liuzhou, China, 545006
        • Research Site
      • Luoyang, China, 471003
        • Research Site
      • Nanchang, China, 330009
        • Research Site
      • Nanjing, China, 210011
        • Research Site
      • Sanya, China, 572000
        • Research Site
      • Shanghai, China, 200032
        • Research Site
      • Shantou, China, 515065
        • Research Site
      • Shiyan, China, 442099
        • Research Site
      • Suining, China, 629000
        • Research Site
      • Tangshan, China, 63000
        • Research Site
      • Tianjin, China, 300000
        • Research Site
      • Yueyang, China, 414000
        • Research Site
      • Zhengzhou, China, 450000
        • Research Site
      • Zigong, China, 643000
        • Research Site
  • Hong Kong
      • Hong Kong, Hong Kong
        • Research Site
      • Hong Kong, Hong Kong, 00000
        • Research Site
      • Hong Kong, Hong Kong, 999077
        • Research Site
  • Malaysia
      • Ampang, Malaysia, 68000
        • Research Site
      • Beseri, Malaysia, 02400
        • Research Site
      • Kuala Kedah, Malaysia, 06600
        • Research Site
      • Puchong, Malaysia, 47100
        • Research Site
      • Sarawak Miri, Malaysia, 98000
        • Research Site
  • South Korea
      • Daegu, South Korea, 42601
        • Research Site
      • Seoul, South Korea, 134-727
        • Research Site
      • Seoul, South Korea, 143-729
        • Research Site
      • Wŏnju, South Korea, 26426
        • Research Site
  • Thailand
      • Bangkok, Thailand, 10700
        • Research Site
      • Banphaeo, Thailand, 74120
        • Research Site
      • Chiang Mai, Thailand, 50200
        • Research Site
      • Phutthamonthon, Thailand, 73170
        • Research Site
      • Ratchathewi, Thailand, 10400
        • Research Site
  • Vietnam
      • Haiphong, Vietnam, 180000
        • Research Site
      • Ho Chi Minh City, Vietnam, 700000
        • Research Site
      • Hochiminh, Vietnam, 700000
        • Research Site
      • Hochiminh City, Vietnam, 700000
        • Research Site
      • Hà Nội, Vietnam, 100000
        • 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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participant must be ≥ 18 years of age
  • Participants with no clinical history of ASCVD and a 10-year ASCVD risk estimated as low
  • Participants who have not received any LLT in the 3 months prior to screening
  • Participants of Asian origin.

Exclusion Criteria:

  • Statin intolerance
  • Uncontrolled severe hypertension
  • Uncontrolled type 2 diabetes mellitus
  • 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: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Laroprovstat

The patient will receive a daily dose of Laroprovstat.
Drug: Laroprovstat

daily oral dose of the Laroprovstat

Drug: Placebo to match rosuvastatin

daily oral dose of the Placebo to match Rosuvastatin
Active Comparator: Rosuvastatin Dose 1

The patient will receive a daily dose of Rosuvastatin 1.
Drug: Rosuvastatin 1

daily oral dose of the Rosuvastatin 1

Other Names:
  • Crestor
Drug: Placebo to match laroprovstat or FDC laroprovstat/rosuvastatin

daily oral dose of the Placebo to match laroprovstat or FDC laroprovstat/rosuvastatin
Active Comparator: Rosuvastatin Dose 2

The patient will receive a daily dose of Rosuvastatin 2.
Drug: Placebo to match laroprovstat or FDC laroprovstat/rosuvastatin

daily oral dose of the Placebo to match laroprovstat or FDC laroprovstat/rosuvastatin

Drug: Rosuvastatin 2

daily oral dose of the Rosuvastatin 2
Experimental: FDC laroprovstat/rosuvastatin Dose combination 1

The patient will receive a daily dose of FDC Laroprovstat/Rosuvastatin 1.
Drug: Placebo to match rosuvastatin

daily oral dose of the Placebo to match Rosuvastatin

Drug: FDC laroprovstat/Rosuvastatin 1

daily oral dose of the FDC Laroprovstat/Rosuvastatin 1
Experimental: FDC laroprovstat/rosuvastatin Dose combination 2

The patient will receive a daily dose of FDC Laroprovstat/Rosuvastatin 2.
Drug: Placebo to match rosuvastatin

daily oral dose of the Placebo to match Rosuvastatin

Drug: FDC laroprovstat/Rosuvastatin 2

daily oral dose of the FDC Laroprovstat/Rosuvastatin 2
Placebo Comparator: Placebo

The patient will receive a daily dose of Placebo.
Drug: Placebo to match rosuvastatin

daily oral dose of the Placebo to match Rosuvastatin

Drug: Placebo to match laroprovstat or FDC laroprovstat/rosuvastatin

daily oral dose of the Placebo to match laroprovstat or FDC laroprovstat/rosuvastatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relative change in LDL-C
Time Frame: Week 8

To compare the effect of treatment with FDC laroprovstat/rosuvastatin Dose 2 versus placebo, rosuvastatin Dose 2, and laroprovstat on LDL-C at Week 8.
Week 8
Relative change in LDL-C
Time Frame: Week 8

To compare the effect of treatment with FDC laroprovstat/rosuvastatin Dose 1 versus placebo, rosuvastatin Dose 1, and laroprovstat on LDL-C at Week 8.
Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relative change in Apo B
Time Frame: Week 8

To compare the effect of treatment with FDC laroprovstat/rosuvastatin versus the individual components and placebo on Apo B at Week 8.
Week 8
Relative change in non-HDL-C
Time Frame: Week 8

To compare the effect of treatment with FDC laroprovstat/rosuvastatin versus the individual components and placebo on non-HDL-C at Week 8.
Week 8
Relative change in total cholesterol
Time Frame: Week 8

To compare the effect of treatment with FDC laroprovstat/rosuvastatin versus the individual components and placebo on total cholesterol at Week 8.
Week 8

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)

December 21, 2026

Primary Completion (Estimated)

October 11, 2027

Study Completion (Estimated)

October 11, 2027

Study Registration Dates

First Submitted

November 5, 2026

First Submitted That Met QC Criteria

November 5, 2026

First Posted (Actual)

November 12, 2026

Study Record Updates

Last Update Posted (Actual)

November 12, 2026

Last Update Submitted That Met QC Criteria

November 5, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D7961C00006

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

product manufactured in and exported from the U.S.

Yes

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.

Subscribe