A new combination pill to lower LDL cholesterol in adults who haven’t taken cholesterol medicine before
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
Run by AstraZeneca · NCT07619131 · Data updated 2026-11-12
This study tests whether a fixed-dose combo pill of laroprovstat and rosuvastatin can lower LDL-C better than laroprovstat alone, rosuvastatin alone, or placebo in adults without prior lipid therapy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 130 Years |
| Sex | All |
| Enrollment | 600 (estimated) |
| Sponsor | AstraZeneca Industry-sponsored |
| Locations | 152 sites (Dothan, Alabama and 151 other locations) |
| Status | Recruiting |
| Started | August 12, 2026 |
| Main results expected | July 30, 2027 |
| Study ends | July 30, 2027 |
| Registry record updated | September 10, 2026 |
| Trial ID | NCT07619131 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 or older with hypercholesterolaemia who have not used lipid-lowering therapy in the past 3 months and have low ASCVD risk.
✕Probably not a fit
Patients who are statin-intolerant, have uncontrolled hypertension or diabetes, or have ASCVD may not benefit from this regimen.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 3 trial compares the effects and safety of a fixed-dose combination of laroprovstat with rosuvastatin against rosuvastatin alone, laroprovstat alone, and placebo in adults with high cholesterol who have not used lipid-lowering therapy recently. Participants are 18 or older and have no history of ASCVD and low 10-year ASCVD risk. The study measures changes in LDL-C and evaluates safety and tolerability. Locations include sites in Dothan, AL; Chandler, AZ; and Phoenix, AZ, sponsored by AstraZeneca. Eligible participants must not have statin intolerance and must have controlled comorbidities to join.
Why it matters
Potential benefit: If successful, participants may achieve greater reductions in LDL-C with a single fixed-dose therapy, potentially simplifying treatment.
How similar studies have gone: Previous studies with combination lipid-lowering therapies have shown LDL-C reductions, supporting exploration of fixed-dose combinations, though this exact formulation is novel for LLT-naïve individuals.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Research Site
Colorado Springs, Colorado, United States Recruiting -
Research Site
Lakeland, Florida, United States Recruiting -
Research Site
Conyers, Georgia, United States Recruiting -
Research Site
Hinesville, Georgia, United States Recruiting -
Research Site
Lexington, Kentucky, United States Recruiting -
Research Site
Millville, New Jersey, United States Recruiting
Show 44 more locations
-
Research Site
Salt Lake City, Utah, United States Recruiting -
Research Site
South Jordan, Utah, United States Recruiting -
Research Site
Hamilton, Ontario, Canada Recruiting -
Research Site
Scarborough Village, Ontario, Canada Recruiting -
Research Site
Stouffville, Ontario, Canada Recruiting -
Research Site
Sherbrooke, Quebec, Canada Recruiting -
Research Site
Dothan, Alabama, United States Not yet recruiting -
Research Site
Chandler, Arizona, United States Not yet recruiting -
Research Site
Phoenix, Arizona, United States Not yet recruiting -
Research Site
Huntington Beach, California, United States Not yet recruiting -
Research Site
Loma Linda, California, United States Not yet recruiting -
Research Site
Lomita, California, United States Not yet recruiting -
Research Site
Long Beach, California, United States Not yet recruiting -
Research Site
San Dimas, California, United States Not yet recruiting -
Research Site
Arvada, Colorado, United States Not yet recruiting -
Research Site
Waterbury, Connecticut, United States Not yet recruiting -
Research Site
Clearwater, Florida, United States Not yet recruiting -
Research Site
DeLand, Florida, United States Not yet recruiting -
Research Site
Hollywood, Florida, United States Not yet recruiting -
Research Site
Jacksonville, Florida, United States Not yet recruiting -
Research Site
Miami Lakes, Florida, United States Not yet recruiting -
Research Site
Ocoee, Florida, United States Not yet recruiting -
Research Site
Plantation, Florida, United States Not yet recruiting -
Research Site
Port Orange, Florida, United States Not yet recruiting -
Research Site
Tampa, Florida, United States Not yet recruiting -
Research Site
Atlanta, Georgia, United States Not yet recruiting -
Research Site
Decatur, Georgia, United States Not yet recruiting -
Research Site
Peachtree Corners, Georgia, United States Not yet recruiting -
Research Site
Champaign, Illinois, United States Not yet recruiting -
Research Site
Chicago, Illinois, United States Not yet recruiting -
Research Site
Chicago, Illinois, United States Not yet recruiting -
Research Site
Island Lake, Illinois, United States Not yet recruiting -
Research Site
Melrose Park, Illinois, United States Not yet recruiting -
Research Site
Palos Hills, Illinois, United States Not yet recruiting -
Research Site
Evansville, Indiana, United States Not yet recruiting -
Research Site
Waterloo, Iowa, United States Not yet recruiting -
Research Site
Derby, Kansas, United States Not yet recruiting -
Research Site
Louisville, Kentucky, United States Not yet recruiting -
Research Site
Zachary, Louisiana, United States Not yet recruiting -
Research Site
Annapolis, Maryland, United States Not yet recruiting -
Research Site
Beltsville, Maryland, United States Not yet recruiting -
Research Site
Bowie, Maryland, United States Not yet recruiting -
Research Site
Lutherville-Timonium, Maryland, United States Not yet recruiting -
Research Site
Oxon Hill, Maryland, United States Not yet recruiting
+102 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: AstraZeneca Clinical Study Information Center
- Email: information.center@astrazeneca.com
- Phone: +18772409479
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Linking social care with healthcare to help manage chronic diseases
This trial tests whether pairing patients with trained community health workers can help them get transportation, healthy food, information, and better access to care to improve health in conditions like hypertension, diabetes, and high cholesterol.
-
Fixed-dose combination of laroprovstat/rosuvastatin vs rosuvastatin alone for high cholesterol
This study tests whether a fixed-dose combo pill of laroprovstat and rosuvastatin lowers LDL cholesterol better than rosuvastatin alone in adults with high cholesterol who have or are at risk for cardiovascular disease.
-
Obicetrapib vs. bempedoic acid for high-risk high cholesterol patients
This phase 3 study tests whether obicetrapib can lower LDL-C more than bempedoic acid in adults with primary non-familial hypercholesterolemia or mixed dyslipidemia who still have high LDL-C despite maximum tolerated therapy.
-
Combination therapy with QCZ484 and Inclisiran for hypertension with high cholesterol
This study tests whether the drug QCZ484, alone or with Inclisiran, lowers cholesterol and helps blood pressure in adults with hypertension and high cholesterol.
-
CTX310 for refractory high triglycerides or LDL cholesterol
This trial will test whether a single IV dose of CTX310 is safe and tolerated in adults whose high triglycerides or LDL cholesterol have not responded to available treatments.
-
Adherence, persistence, and real-life effectiveness of alirocumab 300 mg for people with high cholesterol in Italy
This project will test whether alirocumab 300 mg helps people with high cholesterol in Italy stick with their treatment and lower their cholesterol when used in routine care.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.