Clinical trial Recruiting at 12 sites Phase 3 Interventional Ages 18 to 130

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.

More Hypercholesterolaemia trials

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years to 130 Years
SexAll
Enrollment600 (estimated)
SponsorAstraZeneca
Industry-sponsored
Locations152 sites (Dothan, Alabama and 151 other locations)
StatusRecruiting
StartedAugust 12, 2026
Main results expectedJuly 30, 2027
Study endsJuly 30, 2027
Registry record updatedSeptember 10, 2026
Trial IDNCT07619131 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.