Recruiting

Phase 3

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

Sponsor:

AstraZeneca

Code:

NCT07619118

Conditions

Hypercholesterolaemia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

laroprovstat/rosuvastatin 1

laroprovstat/rosuvastatin 2

laroprovstat/rosuvastatin 3

laroprovstat/rosuvastatin 4

Placebo to match laroprovstat/rosuvastatin 1,2,3

Study Details

Brief 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.

Conditions

Hypercholesterolaemia

Study ID

NCT07619118

Start date

Sep 10, 2026

Status verified date

Oct, 2026

Completion date

May 28, 2027

Anticipated

Primary completion date

May 28, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: laroprovstat/rosuvastatin dose 1

Patient will receive a daily dose of laroprovstat/rosuvastatin 1 and a placebo to match rosuvastatin 1

active comparator: rosuvastatin dose 1

Patient will receive a daily dose of rosuvastatin 1 and placebo to match laroprovstat/rosuvastatin 1

experimental: laroprovstat/rosuvastatin dose 2

Patient will receive a daily dose of laroprovstat/rosuvastatin 2 and a placebo to match rosuvastatin 2

active comparator: rosuvastatin dose 2

Patient will receive a daily dose of rosuvastatin 2 and placebo to match laroprovstat/rosuvastatin 2

experimental: laroprovstat/rosuvastatin dose 3

Patient will receive a daily dose of laroprovstat/rosuvastatin 3 and a placebo to match rosuvastatin 3

active comparator: rosuvastatin dose 3

Patient will receive a daily dose of rosuvastatin 3 and placebo to match laroprovstat/rosuvastatin 3

experimental: laroprovstat/rosuvastatin dose 4

Patient will receive a daily dose of laroprovstat/rosuvastatin 4 and a placebo to match rosuvastatin 4

active comparator: rosuvastatin dose 4

Patient will receive a daily dose of rosuvastatin 4 and placebo to match laroprovstat/rosuvastatin 4

Interventions

laroprovstat/rosuvastatin 1

daily oral dose of the laroprovstat/rosuvastatin 1

laroprovstat/rosuvastatin 2

daily oral dose of the laroprovstat/rosuvastatin 2

laroprovstat/rosuvastatin 3

daily oral dose of the laroprovstat/rosuvastatin 3

laroprovstat/rosuvastatin 4

daily oral dose of the laroprovstat/rosuvastatin 4

Placebo to match laroprovstat/rosuvastatin 1,2,3

Daily oral dose of placebo to match FDC laroprovstat/rosuvastatin 1,2,3

Placebo to match laroprovstat/rosuvastatin 4

Daily oral dose of placebo to match FDC laroprovstat/rosuvastatin 4

Rosuvastatin 1

daily oral dose of rosuvastatin 1

Rosuvastatin 2

daily oral dose of rosuvastatin 2

Rosuvastatin 3

daily oral dose of rosuvastatin 3

Rosuvastatin 4

daily oral dose of rosuvastatin 4

Placebo to match Rosuvastatin

daily oral dose of placebo to match rosuvastatin

Primary outcome measure

Relative change in LDL-C at 8 weeks [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479 information.center@astrazeneca.com

Locations

Research Site

Recruiting

Sun City West, Arizona, United States, 85375

Research Site

Recruiting

Pomona, California, United States, 91768

Research Site

Recruiting

Miami Lakes, Florida, United States, 33016

Research Site

Recruiting

Conyers, Georgia, United States, 30094

Research Site

Recruiting

Decatur, Georgia, United States, 30030

Research Site

Recruiting

Beltsville, Maryland, United States, 20705

Research Site

Recruiting

Houston, Texas, United States, 77040

Research Site

Recruiting

Mesquite, Texas, United States, 75149

Research Site

Recruiting

Sugar Land, Texas, United States, 77478

Research Site

Recruiting

Guelph, Ontario, Canada, N1H 1B1

Research Site

Recruiting

Mississauga, Ontario, Canada, L5K2L3

Research Site

Recruiting

North York, Ontario, Canada, M9N 1W4

Research Site

Recruiting

Stoney Creek, Ontario, Canada, L8J 3W2

Research Site

Recruiting

Toronto, Ontario, Canada, M6G 1M2

More Information

Sponsor

AstraZeneca

Last update posted

Oct 5, 2026

Last verified

Oct, 2026

Keywords

Hypercholesterolaemia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-06. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-10-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.