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
2 other identifiers
interventional
600
0 countries
N/A
Brief Summary
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 being developed for the treatment of hypercholesterolaemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 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
August 17, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2027
Study Completion
Last participant's last visit for all outcomes
July 30, 2027
June 1, 2026
May 1, 2026
12 months
May 26, 2026
May 26, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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
8 weeks
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
8 weeks
Secondary Outcomes (4)
Relative change in LDL-C
8 weeks
Relative change in Apo B
8 weeks
Relative change in non-HDL-C
8 weeks
Relative change in total cholesterol
8 weeks
Study Arms (6)
Laroprovstat
ACTIVE COMPARATORThe patient will receive a daily dose of Laroprovstat
Placebo
PLACEBO COMPARATORThe patient will receive a daily dose of Placebo
Laroprovstat/Rosuvastatin dose combination 1
EXPERIMENTALThe patient will receive a daily dose of Laroprovstat/Rosuvastatin 1
Laroprovstat/Rosuvastatin dose combination 2
EXPERIMENTALThe patient will receive a daily dose of Laroprovstat/Rosuvastatin 2
Rosuvastatin dose 1
ACTIVE COMPARATORThe patient will receive a daily dose of Rosuvastatin 1
Rosuvastatin dose 2
ACTIVE COMPARATORThe patient will receive a daily dose of Rosuvastatin 2
Interventions
daily oral dose of the Laroprovstat/Rosuvastatin 1
daily oral dose of the Placebo to match Rosuvastatin
daily oral dose of the Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1
daily oral dose of the Laroprovstat/Rosuvastatin 2
daily oral dose of the Placebo to match Laroprovstat/Rosuvastatin 2
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Asian origin.
- Statin intolerance
- Uncontrolled severe hypertension
- Uncontrolled type 2 diabetes mellitus
- Inadequately treated hypothyroidism
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 26, 2026
First Posted
June 1, 2026
Study Start (Estimated)
August 17, 2026
Primary Completion (Estimated)
July 30, 2027
Study Completion (Estimated)
July 30, 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.