Clinical trial Recruiting at 16 sites Phase 3 Interventional Ages 18 to 130

Fixed-dose combination of laroprovstat/rosuvastatin vs rosuvastatin alone for high cholesterol

Official title: A Phase III Randomised, Double-Blind, Parallel-Group Study to Assess the Effect of Fixed Dose Combination Laroprovstat/Rosuvastatin Compared With Rosuvastatin on Low-Density Lipoprotein Cholesterol in Patients With Hypercholesterolaemia

Run by AstraZeneca · NCT07619118 · Data updated 2026-11-12

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.

More Hypercholesterolaemia trials

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years to 130 Years
SexAll
Enrollment200 (estimated)
SponsorAstraZeneca
Industry-sponsored
Locations45 sites (Sun City West, Arizona and 44 other locations)
StatusRecruiting
StartedSeptember 10, 2026
Main results expectedMay 28, 2027
Study endsMay 28, 2027
Registry record updatedOctober 5, 2026
Trial IDNCT07619118 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults 18 years and older with hypercholesterolaemia who are on maximally tolerated background lipid-lowering therapy and have prior ASCVD or high risk for ASCVD.

Probably not a fit

Patients who do not meet criteria or experience adverse effects or lack of LDL-C response may not benefit.

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 multiple fixed-dose combinations of laroprovstat/rosuvastatin to rosuvastatin and placebo in adults with hypercholesterolaemia. Participants must be on a stable statin dose at their maximum tolerated level and have either a prior ASCVD event or high risk for a first event. The study will measure changes in LDL-C and assess safety and tolerability. Sites are located in Arizona and California under the lead sponsorship of AstraZeneca. The intervention arms include several dose combinations of laroprovstat/rosuvastatin and matching placebos.

Why it matters

Potential benefit: If successful, the treatment could provide greater LDL-C reduction with acceptable safety for patients needing intensified lipid lowering.

How similar studies have gone: Previous trials with fixed-dose statin combinations have shown LDL-C lowering benefits in high-risk patients, supporting exploring this specific combination.

Who can join: the full rules

Show full inclusion / exclusion criteria
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 it's running

  • Research Site
    Sun City West, Arizona, United States
    Recruiting
  • Research Site
    Pomona, California, United States
    Recruiting
  • Research Site
    Miami Lakes, Florida, United States
    Recruiting
  • Research Site
    Conyers, Georgia, United States
    Recruiting
  • Research Site
    Decatur, Georgia, United States
    Recruiting
  • Research Site
    Beltsville, Maryland, United States
    Recruiting
Show 39 more locations
  • Research Site
    Houston, Texas, United States
    Recruiting
  • Research Site
    Mesquite, Texas, United States
    Recruiting
  • Research Site
    Sugar Land, Texas, United States
    Recruiting
  • Research Site
    Hope Island, Australia
    Recruiting
  • Research Site
    Woolloongabba, Australia
    Recruiting
  • Research Site
    Guelph, Ontario, Canada
    Recruiting
  • Research Site
    Mississauga, Ontario, Canada
    Recruiting
  • Research Site
    North York, Ontario, Canada
    Recruiting
  • Research Site
    Stoney Creek, Ontario, Canada
    Recruiting
  • Research Site
    Toronto, Ontario, Canada
    Recruiting
  • Research Site
    Gardena, California, United States
    Not yet recruiting
  • Research Site
    Lomita, California, United States
    Not yet recruiting
  • Research Site
    Sacramento, California, United States
    Not yet recruiting
  • Research Site
    Jacksonville, Florida, United States
    Not yet recruiting
  • Research Site
    Orlando, Florida, United States
    Not yet recruiting
  • Research Site
    Pembroke Pines, Florida, United States
    Not yet recruiting
  • Research Site
    Peachtree Corners, Georgia, United States
    Not yet recruiting
  • Research Site
    Evansville, Indiana, United States
    Not yet recruiting
  • Research Site
    Indianapolis, Indiana, United States
    Withdrawn
  • Research Site
    Zachary, Louisiana, United States
    Not yet recruiting
  • Research Site
    Rocky Mount, North Carolina, United States
    Not yet recruiting
  • Research Site
    Statesville, North Carolina, United States
    Not yet recruiting
  • Research Site
    Wilmington, North Carolina, United States
    Not yet recruiting
  • Research Site
    Fargo, North Dakota, United States
    Not yet recruiting
  • Research Site
    Anderson, South Carolina, United States
    Not yet recruiting
  • Research Site
    Bristol, Tennessee, United States
    Not yet recruiting
  • Research Site
    Houston, Texas, United States
    Not yet recruiting
  • Research Site
    Burwood, Australia
    Not yet recruiting
  • Research Site
    Hoppers Crossing, Australia
    Not yet recruiting
  • Research Site
    Cambridge, Ontario, Canada
    Suspended
  • Research Site
    Berlin, Germany
    Not yet recruiting
  • Research Site
    Essen, Germany
    Not yet recruiting
  • Research Site
    Frankfurt, Germany
    Not yet recruiting
  • Research Site
    Freiburg im Breisgau, Germany
    Not yet recruiting
  • Research Site
    Hanover, Germany
    Not yet recruiting
  • Research Site
    Kaiserslautern, Germany
    Not yet recruiting
  • Research Site
    Leipzig, Germany
    Not yet recruiting
  • Research Site
    Munich, Germany
    Not yet recruiting
  • Research Site
    Nuremberg, Germany
    Not yet recruiting

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.