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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.
Sponsor: AstraZeneca
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 130 Years
Study Type
INTERVENTIONAL
Enrollment
600
Start Date
2026-08-12
Completion Date
2027-07-30
Last Updated
2026-09-10
Healthy Volunteers
No
Conditions
Interventions
Laroprovstat
daily oral dose of the Laroprovstat
Rosuvastatin 1
daily oral dose of the Rosuvastatin 1
Rosuvastatin 2
daily oral dose of the Rosuvastatin 2
Laroprovstat/Rosuvastatin 1
daily oral dose of the Laroprovstat/Rosuvastatin 1
Placebo to match rosuvastatin
daily oral dose of the Placebo to match Rosuvastatin
Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1
daily oral dose of the Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1
Laroprovstat/Rosuvastatin 2
daily oral dose of the Laroprovstat/Rosuvastatin 2
Placebo to match Laroprovstat/Rosuvastatin 2
daily oral dose of the Placebo to match Laroprovstat/Rosuvastatin 2
Locations (152)
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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
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Shipley, United Kingdom