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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
600
daily oral dose of the Laroprovstat
daily oral dose of the Rosuvastatin 1
daily oral dose of the Rosuvastatin 2
Relative change in LDL-C at 8 weeks
To compare the effect of treatment with FDC laroprovstat/rosuvastatin 2 versus the following on LDL-C at 8 weeks: * Placebo * Rosuvastatin 2 * Laroprovstat
Time frame: 8 weeks
Relative change in LDL-C at 8 weeks
To compare the effect of treatment with FDC laroprovstat/rosuvastatin 1 versus the following on LDL-C at 8 weeks: * Placebo * Rosuvastatin 1 * Laroprovstat
Time frame: 8 weeks
Relative change in LDL-C
To compare the effect of treatment with FDC laroprovstat/rosuvastatin 1 versus rosuvastatin 2 alone on LDL-C at 8 weeks
Time frame: 8 weeks
Relative change in Apo B
To compare the effect of treatment with FDC laroprovstat/rosuvastatin versus the individual components and placebo on apolipoprotein B (Apo B) at 8 weeks
Time frame: 8 weeks
Relative change in non-HDL-C
To compare the effect of treatment with FDC laroprovstat/rosuvastatin versus the individual components and placebo on non-high-density lipoprotein cholesterol (non-HDL-C) at 8 weeks
Time frame: 8 weeks
Relative change in total cholesterol
To compare the effect of treatment with FDC laroprovstat/rosuvastatin versus the individual components and placebo on total cholesterol at 8 weeks
Time frame: 8 weeks
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daily oral dose of the Laroprovstat/Rosuvastatin 1
daily oral dose of the Placebo to match Rosuvastatin
daily oral dose of the Placebo to match Laroprovstat and Laroprovstat/Rosuvastatin 1
daily oral dose of the Laroprovstat/Rosuvastatin 2
daily oral dose of the Placebo to match Laroprovstat/Rosuvastatin 2
Research Site
Dothan, Alabama, United States
NOT_YET_RECRUITINGResearch Site
Chandler, Arizona, United States
NOT_YET_RECRUITINGResearch Site
Phoenix, Arizona, United States
NOT_YET_RECRUITINGResearch Site
Huntington Beach, California, United States
NOT_YET_RECRUITINGResearch Site
Loma Linda, California, United States
NOT_YET_RECRUITINGResearch Site
Lomita, California, United States
NOT_YET_RECRUITINGResearch Site
Long Beach, California, United States
NOT_YET_RECRUITINGResearch Site
San Dimas, California, United States
NOT_YET_RECRUITINGResearch Site
Arvada, Colorado, United States
NOT_YET_RECRUITINGResearch Site
Colorado Springs, Colorado, United States
RECRUITING...and 142 more locations