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NCT07619131PHASE3Recruiting

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.

AstraZeneca

Start Date

8/12/2026

Completion Date

7/30/2027

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 Criteria

Age Range: 18 years to 130 years

Inclusion Criteria: * 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 Exclusion Criteria: * Asian origin. * Statin intolerance * Uncontrolled severe hypertension * Uncontrolled type 2 diabetes mellitus * Inadequately treated hypothyroidism

Interventions

DRUG

Laroprovstat

DRUG

Rosuvastatin 1

DRUG

Rosuvastatin 2

DRUG

Laroprovstat/Rosuvastatin 1

DRUG

Placebo to match rosuvastatin

DRUG

Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1

DRUG

Laroprovstat/Rosuvastatin 2

DRUG

Placebo to match Laroprovstat/Rosuvastatin 2

Interested in This Trial?

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Conditions

Hypercholesterolaemia

Locations

Research Site

Dothan, Alabama 36305

United States

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Chandler, Arizona 85225

United States

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Phoenix, Arizona 85053

United States

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Huntington Beach, California 92647

United States

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Loma Linda, California 92354

United States

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Lomita, California 90717

United States

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Long Beach, California 90815

United States

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San Dimas, California 91773

United States

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Arvada, Colorado 80002

United States

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Colorado Springs, Colorado 80909

United States

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Waterbury, Connecticut 06708

United States

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Clearwater, Florida 33765

United States

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DeLand, Florida 32720

United States

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Hollywood, Florida 33021

United States

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Jacksonville, Florida 32209

United States

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Lakeland, Florida 33813

United States

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Miami Lakes, Florida 33016

United States

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Ocoee, Florida 34761

United States

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Plantation, Florida 33324

United States

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Port Orange, Florida 32127

United States

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Tampa, Florida 33606

United States

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Atlanta, Georgia 30303

United States

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Conyers, Georgia 30094

United States

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Decatur, Georgia 30030

United States

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Hinesville, Georgia 31313

United States

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Peachtree Corners, Georgia 30092

United States

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Champaign, Illinois 61822

United States

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Chicago, Illinois 60607

United States

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Chicago, Illinois 60640

United States

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Island Lake, Illinois 60042

United States

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Melrose Park, Illinois 60160

United States

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Palos Hills, Illinois 60465

United States

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Evansville, Indiana 47714

United States

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Waterloo, Iowa 50701

United States

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Derby, Kansas 67037

United States

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Lexington, Kentucky 40503

United States

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Louisville, Kentucky 40205

United States

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Zachary, Louisiana 70791

United States

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Annapolis, Maryland 21401

United States

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Beltsville, Maryland 20705

United States

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Bowie, Maryland 20715

United States

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Lutherville-Timonium, Maryland 21093

United States

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Oxon Hill, Maryland 20745

United States

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Flint, Michigan 48503

United States

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Troy, Michigan 48098

United States

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Kansas City, Missouri 64108

United States

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St Louis, Missouri 63110

United States

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St Louis, Missouri 63136

United States

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Millville, New Jersey 08332

United States

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Astoria, New York 11106

United States

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Brooklyn, New York 11201

United States

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Brooklyn, New York 11220

United States

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The Bronx, New York 10455

United States

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Durham, North Carolina 27705

United States

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Morehead City, North Carolina 28557

United States

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Statesville, North Carolina 28625

United States

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Wilmington, North Carolina 28401

United States

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Winston-Salem, North Carolina 27157

United States

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Columbus, Ohio 43213

United States

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Dayton, Ohio 45424

United States

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Tulsa, Oklahoma 74137

United States

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Portland, Oregon 97223

United States

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Newport, Pennsylvania 17074

United States

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Smithfield, Pennsylvania 15478

United States

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Anderson, South Carolina 29621

United States

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Knoxville, Tennessee 37938

United States

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Houston, Texas 77002

United States

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Houston, Texas 77087

United States

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Houston, Texas 77099

United States

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San Antonio, Texas 78231

United States

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Tomball, Texas 77375

United States

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Victoria, Texas 77901

United States

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Layton, Utah 84041

United States

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Salt Lake City, Utah 84109

United States

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South Jordan, Utah 84095

United States

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Richmond, Virginia 23219

United States

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Redmond, Washington 98052

United States

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Burgas, 8000

Bulgaria

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Plovdiv, 4002

Bulgaria

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Razgrad, 7200

Bulgaria

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Sevlievo, 5400

Bulgaria

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Sofia, 1202

Bulgaria

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Sofia, 1431

Bulgaria

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Sofia, 1527

Bulgaria

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Varna, 9010

Bulgaria

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Veliko Tarnovo, 5006

Bulgaria

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Hamilton, Ontario L8L 5G4

Canada

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Scarborough Village, Ontario M1R 0B1

Canada

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Stouffville, Ontario L4A1H2

Canada

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Chicoutimi, Quebec G7H 7K9

Canada

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Sherbrooke, Quebec J1J 2G2

Canada

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Victoriaville, Quebec G6P 3Z8

Canada

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Aarhus, 8200

Denmark

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Copenhagen, 2400

Denmark

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Gandrup, 9362

Denmark

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Herlev, 2730

Denmark

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Herning, 7400

Denmark

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Svendborg, 5700

Denmark

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Vejle, 7100

Denmark

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Viborg, 8800

Denmark

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Ahrensburg, 22926

Germany

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Berlin, 10787

Germany

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Bochum, 44789

Germany

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Gladbeck, 45968

Germany

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Hamburg, 20095

Germany

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Hanover, 30449

Germany

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Karlsruhe, 76137

Germany

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Leipzig, 04177

Germany

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Löhne, 32584

Germany

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Magdeburg, 39110

Germany

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Obertshausen, 63179

Germany

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Wiesbaden, 65189

Germany

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Budapest, 1027

Hungary

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Budapest, 1036

Hungary

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Budapest, 1138

Hungary

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Kaposvár, 7400

Hungary

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Zalaegerszeg, 8900

Hungary

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Haifa, 3109601

Israel

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Jerusalem, 9103102

Israel

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Jerusalem, 91120

Israel

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Kfar Saba, 4428164

Israel

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Petah Tikva, 49100

Israel

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Częstochowa, 42-217

Poland

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Gdynia, 81-384

Poland

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Katowice, 40-772

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Lodz, 91-363

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Lodz, 93-338

Poland

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Lublin, 20-011

Poland

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Lublin, 20-718

Poland

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Warsaw, 00-719

Poland

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Warsaw, 02-758

Poland

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Barcelona, 08025

Spain

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Barcelona, 08540

Spain

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Barcelona, 08902

Spain

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Figueres, 17600

Spain

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La Roca del Vallès, 08430

Spain

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Mataró, 08303

Spain

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Viladecans, 08840

Spain

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Ivano-Frankivsk, 76018

Ukraine

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Kyiv, 02002

Ukraine

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Kyiv, 03037

Ukraine

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Kyiv, 03049

Ukraine

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Kyiv, 04114

Ukraine

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Kyiv, 04210

Ukraine

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Lviv, 79016

Ukraine

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Uzhhorod, 88014

Ukraine

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Coventry, CV3 4FJ

United Kingdom

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Knutsford, WA16 9DX

United Kingdom

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London, W6 7HY

United Kingdom

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Orpington, BR5 3QG

United Kingdom

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Poole, BH14 8EE

United Kingdom

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Shipley, BD18 3SA

United Kingdom