The main purpose of this study is to evaluate the safety and tolerability of LY3885125 after administration of single ascending doses in participants with dyslipidemia (part A) and multiple doses in participants with non-alcoholic fatty liver disease (part B). Blood tests will be performed to check how much LY3885125 gets into the bloodstream and how long it takes the body to eliminate it. The study will last up to approximately 49 weeks for part A and 62 weeks for part B, for a total of approximately 111 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
49
Administered SC
Administered SC
Worldwide Clinical Trials, Inc.
San Antonio, Texas, United States
Part A: Number of Participants With One or More Serious Adverse Event(s) Considered by the Investigator to be Related to Study Drug Administration
Part A: A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Time frame: Baseline up to 36 weeks (Part A)
Part B: Number of Participants With One or More SAEs Considered by the Investigator to be Related to Study Drug Administration
Part B: A summary of SAEs and other non-serious AEs, regardless of causality, will be reported in the Reported Adverse Events module
Time frame: Baseline up to 36 weeks (Part B)
Part A: Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve (AUC) of LY3885125
Part A: PK: AUC of LY3885125
Time frame: Baseline up to 36 weeks (Part A)
Part A: PK: Maximum Observed Plasma Concentration (Cmax) of LY3885125
Part A: PK: Cmax of LY3885125
Time frame: Baseline up to 36 weeks (Part A)
Part A: PK: Time of Maximum Observed Concentration (Tmax) of LY3885125
Part A: PK: Tmax of LY3885125
Time frame: Baseline up to 36 weeks (Part A)
Part A: Pharmacodynamics (PD): Change From Baseline in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)
Part A: PD: Change From Baseline in PCSK9
Time frame: Baseline up to Day 169 (Part A)
Part A: PD: Change From Baseline in Apolipoprotein B (ApoB)
Part A: PD: Change From Baseline in ApoB
Time frame: Baseline up to Day 169 (Part A)
Part B Only: PD: Change of Liver Fat Content From Baseline by MRI-PDFF
Part B Only: PD: Change of Liver Fat Content from Baseline by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF)
Time frame: Baseline up to 62 weeks (Part B)
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