A Phase 3 interventional study of laroprovstat/rosuvastatin 1 and laroprovstat/rosuvastatin 2 in Hypercholesterolaemia, sponsored by AstraZeneca. Recruiting at 45 sites in 4 countries. Open to participants aged 18 Years to 130 Years. Per ClinicalTrials.gov, last updated 2026-10-05.
Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment
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.
1,175 studies on the registry are indexed under Hypercholesterolemia; 93 are open to participants now.
This study's planned enrollment of 200 is above the median of 110 across 975 interventional studies indexed under Hypercholesterolemia.
Browse Hypercholesterolemia studies →AstraZeneca is the lead sponsor of 3,499 studies on the registry; 270 are open to participants now.
Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patient will receive a daily dose of laroprovstat/rosuvastatin 1 and a placebo to match rosuvastatin 1
Combination Product: laroprovstat/rosuvastatin 1 · Drug: Placebo to match Rosuvastatin
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 · Drug: Rosuvastatin 1
Patient will receive a daily dose of laroprovstat/rosuvastatin 2 and a placebo to match rosuvastatin 2
Combination Product: laroprovstat/rosuvastatin 2 · Drug: Placebo to match Rosuvastatin
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 · Drug: Rosuvastatin 2
Patient will receive a daily dose of laroprovstat/rosuvastatin 3 and a placebo to match rosuvastatin 3
Combination Product: laroprovstat/rosuvastatin 3 · Drug: Placebo to match Rosuvastatin
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 · Drug: Rosuvastatin 3
Patient will receive a daily dose of laroprovstat/rosuvastatin 4 and a placebo to match rosuvastatin 4
Combination Product: laroprovstat/rosuvastatin 4 · Drug: Placebo to match Rosuvastatin
Patient will receive a daily dose of rosuvastatin 4 and placebo to match laroprovstat/rosuvastatin 4
Drug: Placebo to match laroprovstat/rosuvastatin 4 · Drug: Rosuvastatin 4
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 rosuvastatin 1
daily oral dose of rosuvastatin 2
daily oral dose of rosuvastatin 3
daily oral dose of rosuvastatin 4
daily oral dose of placebo to match rosuvastatin
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
Time frame: 8 weeks
Relative change in Apo B at 8 weeks
To compare the effect of treatment with laroprovstat/rosuvastatin versus rosuvastatin on Apo B at 8 weeks
Time frame: 8 weeks
Relative change in non-HDL-C at 8 weeks
To compare the effect of treatment with laroprovstat/rosuvastatin versus rosuvastatin on non-HDL-C at 8 weeks
Time frame: 8 weeks
Relative change in total cholesterol at 8 weeks
To compare the effect of treatment with laroprovstat/rosuvastatin versus rosuvastatin on total cholesterol at 8 weeks
Time frame: 8 weeks
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan
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
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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