A Phase III Study to Assess the Effect of FDC Laroprovstat/Rosuvastatin Compared With Laroprovstat, Rosuvastatin and Placebo on LDL-C in LLT-naïve Patients.
Recruiting · NCT07619131 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
LaroprovstatLaroprovstat/Rosuvastatin 1Laroprovstat/Rosuvastatin 2Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1Placebo to match Laroprovstat/Rosuvastatin 2Placebo to match rosuvastatinRosuvastatin 1Rosuvastatin 2
What this trial is about
This is a study to evaluate the effect on LDL-C and the safety and tolerability of FDC laroprovstat/rosuvastatin in LLT-naïve patients. Laroprovstat is a small molecule that reduces the amount of LDL-C in the blood. Laroprovstat and FDC laroprovstat/rosuvastatin are being developed for the treatment of hypercholesterolaemia.
Who can take part
Age range
18 Years to 130 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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 is running
60 locations listed across 29 US states.
- Research Site - Dothan, Alabama, United States
- Research Site - Chandler, Arizona, United States
- Research Site - Phoenix, Arizona, United States
- Research Site - Huntington Beach, California, United States
- Research Site - Loma Linda, California, United States
- Research Site - Lomita, California, United States
- Research Site - Long Beach, California, United States
- Research Site - San Dimas, California, United States
- Research Site - Arvada, Colorado, United States
- Research Site - Colorado Springs, Colorado, United States
- Research Site - Waterbury, Connecticut, United States
- Research Site - Clearwater, Florida, United States
- Research Site - DeLand, Florida, United States
- Research Site - Hollywood, Florida, United States
- Research Site - Jacksonville, Florida, United States
- Research Site - Lakeland, Florida, United States
- Research Site - Miami Lakes, Florida, United States
- Research Site - Ocoee, Florida, United States
- Research Site - Plantation, Florida, United States
- Research Site - Port Orange, Florida, United States
- Research Site - Tampa, Florida, United States
- Research Site - Atlanta, Georgia, United States
- Research Site - Conyers, Georgia, United States
- Research Site - Decatur, Georgia, United States
- Research Site - Hinesville, Georgia, United States
- Research Site - Peachtree Corners, Georgia, United States
- Research Site - Champaign, Illinois, United States
- Research Site - Chicago, Illinois, United States
- Research Site - Chicago, Illinois, United States
- Research Site - Island Lake, Illinois, United States
- Research Site - Melrose Park, Illinois, United States
- Research Site - Palos Hills, Illinois, United States
- Research Site - Evansville, Indiana, United States
- Research Site - Waterloo, Iowa, United States
- Research Site - Derby, Kansas, United States
- Research Site - Lexington, Kentucky, United States
- Research Site - Louisville, Kentucky, United States
- Research Site - Zachary, Louisiana, United States
- Research Site - Annapolis, Maryland, United States
- Research Site - Beltsville, Maryland, United States
- Research Site - Bowie, Maryland, United States
- Research Site - Lutherville-Timonium, Maryland, United States
- Research Site - Oxon Hill, Maryland, United States
- Research Site - Flint, Michigan, United States
- Research Site - Troy, Michigan, United States
- Research Site - Kansas City, Missouri, United States
- Research Site - St Louis, Missouri, United States
- Research Site - St Louis, Missouri, United States
- Research Site - Millville, New Jersey, United States
- Research Site - Astoria, New York, United States
- Research Site - Brooklyn, New York, United States
- Research Site - Brooklyn, New York, United States
- Research Site - The Bronx, New York, United States
- Research Site - Durham, North Carolina, United States
- Research Site - Morehead City, North Carolina, United States
- Research Site - Statesville, North Carolina, United States
- Research Site - Wilmington, North Carolina, United States
- Research Site - Winston-Salem, North Carolina, United States
- Research Site - Columbus, Ohio, United States
- Research Site - Dayton, Ohio, United States
Showing 60 of 152 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →