Fixed-dose combination of laroprovstat/rosuvastatin vs rosuvastatin alone for high cholesterol
Official title: 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
Run by AstraZeneca · NCT07619118 · Data updated 2026-11-12
This study tests whether a fixed-dose combo pill of laroprovstat and rosuvastatin lowers LDL cholesterol better than rosuvastatin alone in adults with high cholesterol who have or are at risk for cardiovascular disease.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 130 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | AstraZeneca Industry-sponsored |
| Locations | 45 sites (Sun City West, Arizona and 44 other locations) |
| Status | Recruiting |
| Started | September 10, 2026 |
| Main results expected | May 28, 2027 |
| Study ends | May 28, 2027 |
| Registry record updated | October 5, 2026 |
| Trial ID | NCT07619118 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years and older with hypercholesterolaemia who are on maximally tolerated background lipid-lowering therapy and have prior ASCVD or high risk for ASCVD.
✕Probably not a fit
Patients who do not meet criteria or experience adverse effects or lack of LDL-C response may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 3 trial compares multiple fixed-dose combinations of laroprovstat/rosuvastatin to rosuvastatin and placebo in adults with hypercholesterolaemia. Participants must be on a stable statin dose at their maximum tolerated level and have either a prior ASCVD event or high risk for a first event. The study will measure changes in LDL-C and assess safety and tolerability. Sites are located in Arizona and California under the lead sponsorship of AstraZeneca. The intervention arms include several dose combinations of laroprovstat/rosuvastatin and matching placebos.
Why it matters
Potential benefit: If successful, the treatment could provide greater LDL-C reduction with acceptable safety for patients needing intensified lipid lowering.
How similar studies have gone: Previous trials with fixed-dose statin combinations have shown LDL-C lowering benefits in high-risk patients, supporting exploring this specific combination.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Sun City West, Arizona, United States Recruiting -
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Pomona, California, United States Recruiting -
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Miami Lakes, Florida, United States Recruiting -
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Conyers, Georgia, United States Recruiting -
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Decatur, Georgia, United States Recruiting -
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Beltsville, Maryland, United States Recruiting
Show 39 more locations
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Houston, Texas, United States Recruiting -
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Mesquite, Texas, United States Recruiting -
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Sugar Land, Texas, United States Recruiting -
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Hope Island, Australia Recruiting -
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Woolloongabba, Australia Recruiting -
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Guelph, Ontario, Canada Recruiting -
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Mississauga, Ontario, Canada Recruiting -
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North York, Ontario, Canada Recruiting -
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Stoney Creek, Ontario, Canada Recruiting -
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Toronto, Ontario, Canada Recruiting -
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Gardena, California, United States Not yet recruiting -
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Lomita, California, United States Not yet recruiting -
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Sacramento, California, United States Not yet recruiting -
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Jacksonville, Florida, United States Not yet recruiting -
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Orlando, Florida, United States Not yet recruiting -
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Pembroke Pines, Florida, United States Not yet recruiting -
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Peachtree Corners, Georgia, United States Not yet recruiting -
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Evansville, Indiana, United States Not yet recruiting -
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Indianapolis, Indiana, United States Withdrawn -
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Zachary, Louisiana, United States Not yet recruiting -
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Rocky Mount, North Carolina, United States Not yet recruiting -
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Statesville, North Carolina, United States Not yet recruiting -
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Wilmington, North Carolina, United States Not yet recruiting -
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Fargo, North Dakota, United States Not yet recruiting -
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Anderson, South Carolina, United States Not yet recruiting -
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Bristol, Tennessee, United States Not yet recruiting -
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Houston, Texas, United States Not yet recruiting -
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Burwood, Australia Not yet recruiting -
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Hoppers Crossing, Australia Not yet recruiting -
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Cambridge, Ontario, Canada Suspended -
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Berlin, Germany Not yet recruiting -
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Essen, Germany Not yet recruiting -
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Frankfurt, Germany Not yet recruiting -
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Freiburg im Breisgau, Germany Not yet recruiting -
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Hanover, Germany Not yet recruiting -
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Kaiserslautern, Germany Not yet recruiting -
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Leipzig, Germany Not yet recruiting -
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Munich, Germany Not yet recruiting -
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Nuremberg, Germany Not yet recruiting
Study contacts
- Study coordinator: AstraZeneca Clinical Study Information Center
- Email: information.center@astrazeneca.com
- Phone: 1-877-240-9479
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.