A Phase III Study to Assess the Effect of FDC Laroprovstat/Rosuvastatin Compared With Rosuvastatin on LDL-C in Patients With Hypercholesterolaemia
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
2 other identifiers
interventional
200
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Sep 2026
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 26, 2026
CompletedFirst Posted
Study publicly available on registry
June 1, 2026
CompletedStudy Start
First participant enrolled
September 15, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
May 28, 2027
Study Completion
Last participant's last visit for all outcomes
May 28, 2027
June 1, 2026
May 1, 2026
9 months
May 26, 2026
May 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Relative change in LDL-C at 8 weeks
To compare the effect of treatment with laroprovstat/rosuvastatin versus rosuvastatin on LDL-C at 8 weeks
8 weeks
Secondary Outcomes (3)
Relative change in Apo B at 8 weeks
8 weeks
Relative change in non-HDL-C at 8 weeks
8 weeks
Relative change in total cholesterol at 8 weeks
8 weeks
Study Arms (8)
laroprovstat/rosuvastatin dose 1
EXPERIMENTALPatient will receive a daily dose of laroprovstat/rosuvastatin 1 and a placebo to match rosuvastatin 1
rosuvastatin dose 1
ACTIVE COMPARATORPatient will receive a daily dose of rosuvastatin 1 and placebo to match laroprovstat/rosuvastatin 1
laroprovstat/rosuvastatin dose 2
EXPERIMENTALPatient will receive a daily dose of laroprovstat/rosuvastatin 2 and a placebo to match rosuvastatin 2
rosuvastatin dose 2
ACTIVE COMPARATORPatient will receive a daily dose of rosuvastatin 2 and placebo to match laroprovstat/rosuvastatin 2
laroprovstat/rosuvastatin dose 3
EXPERIMENTALPatient will receive a daily dose of laroprovstat/rosuvastatin 3 and a placebo to match rosuvastatin 3
rosuvastatin dose 3
ACTIVE COMPARATORPatient will receive a daily dose of rosuvastatin 3 and placebo to match laroprovstat/rosuvastatin 3
laroprovstat/rosuvastatin dose 4
EXPERIMENTALPatient will receive a daily dose of laroprovstat/rosuvastatin 4 and a placebo to match rosuvastatin 4
rosuvastatin dose 4
ACTIVE COMPARATORPatient will receive a daily dose of rosuvastatin 4 and placebo to match laroprovstat/rosuvastatin 4
Interventions
daily oral dose of the laroprovstat/rosuvastatin 1
daily oral dose of the laroprovstat/rosuvastatin 2
daily oral dose of the laroprovstat/rosuvastatin 3
daily oral dose of the laroprovstat/rosuvastatin 4
Daily oral dose of placebo to match FDC laroprovstat/rosuvastatin 1,2,3
Daily oral dose of placebo to match FDC laroprovstat/rosuvastatin 4
daily oral dose of placebo to match rosuvastatin
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Asian origin
- Uncontrolled severe hypertension
- Uncontrolled T2DM
- Inadequately treated hypothyroidism
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 26, 2026
First Posted
June 1, 2026
Study Start (Estimated)
September 15, 2026
Primary Completion (Estimated)
May 28, 2027
Study Completion (Estimated)
May 28, 2027
Last Updated
June 1, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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.
- 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
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.