This a multicenter, Phase 2b, double-blind, placebo-controlled, parallel group study to provide data on efficacy and safety of LY3561774 administered subcutaneously at various doses in participants with mixed dyslipidemia and on a stable dose of a statin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
205
Percent Change From Baseline for Apolipoprotein B (ApoB) at Day 180
Change in apoB levels from baseline to Day 180 expressed as a percentage of the baseline levels. Least Square Mean (LS mean) using Mixed Model for Repeated Measures (MMRM) model adjusted for baseline.
Time frame: Baseline, Day 180
Percent Change From Baseline for Angiopoietin-like Protein 3 (ANGPTL3) at Day 180
Change in ANGPTL3 levels from baseline to Day 180 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.
Time frame: Baseline, Day 180
Percent Change From Baseline for Low Density Lipoprotein-Cholesterol (LDL-C) at Day 180
Change in LDL-C levels from baseline to the day 180 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.
Time frame: Baseline, Day 180
Percent Change From Baseline for High Density Lipoprotein-Cholesterol (HDL-C) at Day 180
Change in HDL-C levels from baseline to the Day 180 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.
Time frame: Baseline, Day 180
Percent Change From Baseline for Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) at Day 180
Change in non-HDL-C levels from baseline to the Day 180 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.
Time frame: Baseline, Day 180
Percent Change From Baseline for Triglycerides at Day 180
Change in triglycerides levels from baseline to the Day 180 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.
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Chase Medical Research, LLC
Waterbury, Connecticut, United States
MD Medical Research
Oxon Hill, Maryland, United States
NECCR PrimaCare Research
Fall River, Massachusetts, United States
Premier Research
Trenton, New Jersey, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Preferred Primary Care Physicians
Uniontown, Pennsylvania, United States
Centro de Investigaciones Metabólicas (CINME)
Ciudad Autónoma de Buenos Aire, Buenos Air, Argentina
Glenny Corp
Buenos Aires, Ciudad Aut, Argentina
CIPREC
CABA, Ciudad Aut, Argentina
Investigaciones Medicas Imoba Srl
Buenos Aires, Ciudad Autónoma de Buenos Aire, Argentina
...and 31 more locations
Time frame: Baseline, Day 180
Percent Change From Baseline for Angiopoietin-like Protein 3 (ANGPTL3)
Change in ANGPTL3 levels from baseline to Day 270 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.
Time frame: Baseline, Day 270
Percent Change From Baseline for Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)
Change in non-HDL-C levels from baseline to the Day 270 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.
Time frame: Baseline, Day 270
Percent Change From Baseline for High Density Lipoprotein-Cholesterol (HDL-C)
Change in HDL-C levels from baseline to the Day 270 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.
Time frame: Baseline, Day 270
Percent Change From Baseline for Low Density Lipoprotein-Cholesterol (LDL-C)
Change in LDL-C levels from baseline to the day 270 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.
Time frame: Baseline, Day 270
Percent Change From Baseline for Apolipoprotein B (ApoB)
Change in apoB levels from baseline to Day 270 expressed as a percentage of the baseline levels. LS mean using MMRM model adjusted for baseline.
Time frame: Baseline, Day 270
Percent Change From Baseline for Triglycerides
Change in triglycerides levels from baseline to the Day 270 expressed as a percentage of the baseline levels. LS Mean from MMRM model adjusted for baseline and treatment.
Time frame: Baseline, Day 270
Pharmacokinetics (PK): Seady State Area Under the Concentration Curve From Hour 0 Extrapolated to Infinity (AUC 0-∞) of LY3561774
PK: Seady State AUC (0-∞) of LY3561774
Time frame: On Day 0: 0.5 hour (hr) and at the latest time after 2 hr post-dose, Day 90: 24 to 48 hr postdose