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NCT07619118PHASE3Recruiting

A Phase III Study to Assess the Effect of FDC Laroprovstat/Rosuvastatin Compared With Rosuvastatin on LDL-C in Patients With Hypercholesterolaemia

AstraZeneca

Start Date

9/10/2026

Completion Date

5/28/2027

Summary

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.

Eligibility Criteria

Age Range: 18 years to 130 years

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

Interventions

COMBINATION_PRODUCT

laroprovstat/rosuvastatin 1

COMBINATION_PRODUCT

laroprovstat/rosuvastatin 2

COMBINATION_PRODUCT

laroprovstat/rosuvastatin 3

COMBINATION_PRODUCT

laroprovstat/rosuvastatin 4

DRUG

Placebo to match laroprovstat/rosuvastatin 1,2,3

DRUG

Placebo to match laroprovstat/rosuvastatin 4

DRUG

Rosuvastatin 1

DRUG

Rosuvastatin 2

DRUG

Rosuvastatin 3

DRUG

Rosuvastatin 4

DRUG

Placebo to match Rosuvastatin

Interested in This Trial?

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Conditions

Hypercholesterolaemia

Locations

Research Site

Sun City West, Arizona 85375

United States

Research Site

Gardena, California 90247

United States

Research Site

Lomita, California 90717

United States

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Pomona, California 91768

United States

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Sacramento, California 95821

United States

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Jacksonville, Florida 32216

United States

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Miami Lakes, Florida 33016

United States

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Orlando, Florida 32807

United States

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Pembroke Pines, Florida 33029

United States

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Conyers, Georgia 30094

United States

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Decatur, Georgia 30030

United States

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Peachtree Corners, Georgia 30092

United States

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Evansville, Indiana 47714

United States

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Indianapolis, Indiana 46260

United States

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Zachary, Louisiana 70791

United States

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Beltsville, Maryland 20705

United States

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Rocky Mount, North Carolina 27804

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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Fargo, North Dakota 58104

United States

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Anderson, South Carolina 29621

United States

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Bristol, Tennessee 37620

United States

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Houston, Texas 77002

United States

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Houston, Texas 77040

United States

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Mesquite, Texas 75149

United States

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Sugar Land, Texas 77478

United States

Research Site

Burwood, 2134

Australia

Research Site

Hope Island, 4212

Australia

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Hoppers Crossing, 3029

Australia

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Woolloongabba, 4102

Australia

Research Site

Cambridge, Ontario N1R 6V6

Canada

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Guelph, Ontario N1H 1B1

Canada

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Mississauga, Ontario L5K2L3

Canada

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North York, Ontario M9N 1W4

Canada

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Stoney Creek, Ontario L8J 3W2

Canada

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Toronto, Ontario M6G 1M2

Canada

Research Site

Berlin, 10117

Germany

Research Site

Essen, 45355

Germany

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Frankfurt, 60596

Germany

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Freiburg im Breisgau, 79106

Germany

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Hanover, 30159

Germany

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Kaiserslautern, 67655

Germany

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Leipzig, 04103

Germany

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Munich, 80809

Germany

Research Site

Nuremberg, 90402

Germany