A Study of LY3875383 in Healthy Participants and Participants With Hypertriglyceridemia
Hypertriglyceridemia
About this trial
This is an interventional basic science trial for Hypertriglyceridemia
Eligibility Criteria
Inclusion Criteria: All participants: Have a body mass index (BMI) between 18.5 and 40 kilograms per square meter (kg/m²), inclusive. Males who agree to follow contraceptive requirements, or women not of childbearing potential (WNOCBP). Healthy participants (Part A): • Participants must be overtly healthy, as determined by medical evaluation. For Part B: • Participants must be first-generation Japanese, defined as the participant's biological parents, and all of the participant's biological grandparents must be of exclusive Japanese descent and born in Japan. Hypertriglyceridemia participants (Parts C and D): For Part C: Have history of very high triglyceride (lipid) level 500 mg/dL ≤ TG <2000 mg/dL, which needs to be further confirmed at screening. Participants must be on a lipid-modifying diet and can be on stable lipid-lowering drugs (LLDs) for at least 8 weeks before screening and plan to continue the same throughout the study duration. For Part D: Have history of high triglyceride (lipid) level between 150 mg/dL and 500 mg/dL inclusive at pre-screening or based on medical history and confirmed at screening and Low-density lipoprotein cholesterol (LDL-C) level of ≥40 mg/dL. Participants must be on a stable moderate or high-intensity dose of a statin for at least 8 weeks before screening and plan to continue the same medication and dose throughout the study duration. Exclusion Criteria: All participants: Participants must not be currently participating in or completed a clinical trial within the last 30 days Have donated blood of more than 500 mL within the previous 3 months Have one of the following viral infections: hepatitis B virus, hepatitis C virus or human immunodeficiency virus (HIV). Participants must not be heavy alcohol drinkers or cigarette smokers. For Part C: Have active pancreatitis within the last 6 months
Sites / Locations
- ProSciento, Inc
- Altasciences Clinical Los Angeles, Inc
- Qps-Mra, Llc
- Endeavor Clinical Trials
- Lilly Centre for Clinical Pharmacology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Placebo Comparator
Placebo Comparator
LY3875383 (Part A)
LY3875383 (Part B)
LY3875383 (Part C)
LY3875383 (Part D)
Placebo (Part A)
Placebo (Part B)
Placebo (Part C)
Placebo (Part D)
Single-ascending doses of LY3875383 administered subcutaneously (SC).
Single doses of LY3875383 administered SC.
Single doses of LY3875383 administered SC.
Single doses of LY3875383 administered SC.
Placebo administered SC.
Placebo administered SC.
Placebo administered SC.
Placebo administered SC.