NCT07619118 · AstraZeneca
A Phase III Study to Assess the Effect of FDC Laroprovstat/Rosuvastatin Compared With Rosuvastatin on LDL-C in Patients With Hypercholesterolaemia
What this study is about
The purpose of this study is to evaluate the effect on low-density lipoprotein-cholesterol (LDL-C) and the safety and how well patients handle the treatment 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.
View original scientific description
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.
Interventions
COMBINATION_PRODUCT
laroprovstat/rosuvastatin 1
daily oral dose of the laroprovstat/rosuvastatin 1
COMBINATION_PRODUCT
laroprovstat/rosuvastatin 2
daily oral dose of the laroprovstat/rosuvastatin 2
COMBINATION_PRODUCT
laroprovstat/rosuvastatin 3
daily oral dose of the laroprovstat/rosuvastatin 3
COMBINATION_PRODUCT
laroprovstat/rosuvastatin 4
daily oral dose of the laroprovstat/rosuvastatin 4
DRUG
Placebo to match laroprovstat/rosuvastatin 1,2,3
Daily oral dose of placebo to match FDC laroprovstat/rosuvastatin 1,2,3
DRUG
Placebo to match laroprovstat/rosuvastatin 4
Daily oral dose of placebo to match FDC laroprovstat/rosuvastatin 4
DRUG
Rosuvastatin 1
daily oral dose of rosuvastatin 1
DRUG
Rosuvastatin 2
daily oral dose of rosuvastatin 2
DRUG
Rosuvastatin 3
daily oral dose of rosuvastatin 3
DRUG
Rosuvastatin 4
daily oral dose of rosuvastatin 4
DRUG
Placebo to match Rosuvastatin
daily oral dose of placebo to match rosuvastatin
Primary outcome measures
Relative change in LDL-C at 8 weeks
Time frame: 8 weeks
To compare the effect of treatment with laroprovstat/rosuvastatin versus rosuvastatin on LDL-C at 8 weeks
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Sun City West, Arizona
- Gardena, California
- Lomita, California
- Pomona, California
- Sacramento, California
- Jacksonville, Florida
- Miami Lakes, Florida
- Orlando, Florida
- Pembroke Pines, Florida
- Conyers, Georgia
- Decatur, Georgia
- Peachtree Corners, Georgia
And 13 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 5, 2026 · Source of record for eligibility and locations