RecruitingPhase 3NCT07619131

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


Sponsor

AstraZeneca

Enrollment

600 participants

Start Date

Aug 12, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 130 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Laroprovstat, a drug called Laroprovstat/Rosuvastatin 1, and others for people with hypercholesterolaemia. The study is currently recruiting participants at 152 locations. People eligible for this study include aged 18 Years to 130 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLaroprovstat

daily oral dose of the Laroprovstat

DRUGRosuvastatin 1

daily oral dose of the Rosuvastatin 1

DRUGRosuvastatin 2

daily oral dose of the Rosuvastatin 2

DRUGLaroprovstat/Rosuvastatin 1

daily oral dose of the Laroprovstat/Rosuvastatin 1

DRUGPlacebo to match rosuvastatin

daily oral dose of the Placebo to match Rosuvastatin

DRUGPlacebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1

daily oral dose of the Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1

DRUGLaroprovstat/Rosuvastatin 2

daily oral dose of the Laroprovstat/Rosuvastatin 2

DRUGPlacebo to match Laroprovstat/Rosuvastatin 2

daily oral dose of the Placebo to match Laroprovstat/Rosuvastatin 2


Locations(152)

Research Site

Dothan, Alabama, United States

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Chandler, Arizona, United States

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Phoenix, Arizona, United States

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Huntington Beach, California, United States

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Loma Linda, California, United States

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Lomita, California, United States

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Long Beach, California, United States

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San Dimas, California, United States

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Arvada, Colorado, United States

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Colorado Springs, Colorado, United States

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Waterbury, Connecticut, United States

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Clearwater, Florida, United States

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DeLand, Florida, United States

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Hollywood, Florida, United States

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Jacksonville, Florida, United States

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Lakeland, Florida, United States

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Miami Lakes, Florida, United States

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Ocoee, Florida, United States

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Plantation, Florida, United States

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Port Orange, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Conyers, Georgia, United States

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Decatur, Georgia, United States

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Hinesville, Georgia, United States

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Peachtree Corners, Georgia, United States

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Champaign, Illinois, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Island Lake, Illinois, United States

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Melrose Park, Illinois, United States

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Palos Hills, Illinois, United States

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Evansville, Indiana, United States

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Waterloo, Iowa, United States

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Derby, Kansas, United States

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Lexington, Kentucky, United States

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Louisville, Kentucky, United States

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Zachary, Louisiana, United States

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Annapolis, Maryland, United States

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Beltsville, Maryland, United States

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Bowie, Maryland, United States

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Lutherville-Timonium, Maryland, United States

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Oxon Hill, Maryland, United States

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Flint, Michigan, United States

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Troy, Michigan, United States

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Kansas City, Missouri, United States

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St Louis, Missouri, United States

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St Louis, Missouri, United States

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Millville, New Jersey, United States

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Astoria, New York, United States

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Brooklyn, New York, United States

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Brooklyn, New York, United States

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The Bronx, New York, United States

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Durham, North Carolina, United States

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Morehead City, North Carolina, United States

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Statesville, North Carolina, United States

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Wilmington, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Columbus, Ohio, United States

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Dayton, Ohio, United States

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Tulsa, Oklahoma, United States

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Portland, Oregon, United States

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Newport, Pennsylvania, United States

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Smithfield, Pennsylvania, United States

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Anderson, South Carolina, United States

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Knoxville, Tennessee, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Tomball, Texas, United States

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Victoria, Texas, United States

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Layton, Utah, United States

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Salt Lake City, Utah, United States

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South Jordan, Utah, United States

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Richmond, Virginia, United States

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Redmond, Washington, United States

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Burgas, Bulgaria

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Plovdiv, Bulgaria

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Razgrad, Bulgaria

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Sevlievo, Bulgaria

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Sofia, Bulgaria

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Sofia, Bulgaria

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Sofia, Bulgaria

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Varna, Bulgaria

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Veliko Tarnovo, Bulgaria

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Hamilton, Ontario, Canada

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Scarborough Village, Ontario, Canada

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Stouffville, Ontario, Canada

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Chicoutimi, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Victoriaville, Quebec, Canada

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Aarhus, Denmark

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Copenhagen, Denmark

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Gandrup, Denmark

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Herlev, Denmark

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Herning, Denmark

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Svendborg, Denmark

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Vejle, Denmark

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Viborg, Denmark

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Ahrensburg, Germany

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Berlin, Germany

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Bochum, Germany

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Gladbeck, Germany

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Hamburg, Germany

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Hanover, Germany

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Karlsruhe, Germany

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Leipzig, Germany

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Löhne, Germany

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Magdeburg, Germany

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Obertshausen, Germany

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Wiesbaden, Germany

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Budapest, Hungary

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Budapest, Hungary

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Budapest, Hungary

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Kaposvár, Hungary

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Zalaegerszeg, Hungary

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Haifa, Israel

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Jerusalem, Israel

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Jerusalem, Israel

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Kfar Saba, Israel

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Petah Tikva, Israel

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Częstochowa, Poland

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Gdynia, Poland

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Katowice, Poland

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Lodz, Poland

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Lodz, Poland

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Lublin, Poland

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Lublin, Poland

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Warsaw, Poland

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Warsaw, Poland

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Barcelona, Spain

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Barcelona, Spain

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Barcelona, Spain

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Figueres, Spain

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La Roca del Vallès, Spain

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Mataró, Spain

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Viladecans, Spain

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Ivano-Frankivsk, Ukraine

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Kyiv, Ukraine

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Kyiv, Ukraine

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Kyiv, Ukraine

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Kyiv, Ukraine

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Kyiv, Ukraine

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Lviv, Ukraine

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Uzhhorod, Ukraine

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Coventry, United Kingdom

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Knutsford, United Kingdom

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London, United Kingdom

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Orpington, United Kingdom

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Poole, United Kingdom

Research Site

Shipley, United Kingdom

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NCT07619131


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