Hypertriglyceridemia
Conditions
Brief summary
The main purpose of this study is to determine the tolerability and side effects related to LY3875383 given as a single injection under the skin to healthy participants and participants with elevated triglyceride (TG) levels.The study will also assess how fast LY3875383 gets into the blood stream and how long the body takes to get rid of it. Each enrolled participant will receive a single dose of either LY3875383 or placebo.The study will be conducted in four parts (A, B, C and D) and may last up to approximately 28 to 56 weeks including screening.
Interventions
DRUGLY3875383
Administered SC.
DRUGPlacebo
Administered SC.
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | Baseline through Week 53 | A summary of TEAEs and SAEs, regardless of causality, will be reported in the Reported Adverse Events module |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK):Area Under the Concentration Versus Time Curve (AUC) of LY3875383 | Predose up to Day 8 post dose | PK: AUC of LY3875383 |
| PK: Maximum Observed Concentration (Cmax) of LY3875383 | Predose up to Day 8 post dose | PK: Cmax of LY3875383 |
| Part C and D only: Pharmacodynamics (PD): Percentage Change from Baseline in Fasting Triglyceride (TG) | Baseline through up to Week 53 | Part C and D only: PD: Percentage Change from Baseline in Fasting TG |
| Part D only: PD: Percentage Change from Baseline in Fasting Non-High-Density Lipoprotein Cholesterol (HDL-C) | Baseline through Week 53 | Part D only: PD: Percentage Change from Baseline in Fasting non-HDL-C |
Countries
Singapore
Outcome results
None listed