A Study of LY3875383 in Healthy Participants and Participants With Hypertriglyceridemia

J4D-MC-EZFA -

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[SR1] .

Trial Summary

Age Range
18 - 70 years
Conditions the trial is for
Dyslipidemia
What the trial is testing?
LY3875383
Could I receive a Placebo?
Yes
Enrollment Goal
41
Trial Dates
Nov 14, 2022 - Jan 10, 2024
How long will I be in the trial?
The study will last about 28 and 56 weeks and may require up to 18 visits (1 inpatient and up to 17 outpatient visits) for parts A, C, D, and 12 visits for part B.
Trial Phase
I

Key Requirements

Clinical trials have inclusion and exclusion requirements to determine which individuals qualify for participation. Listed below are key requirements for this clinical trial, but there may be additional requirements to qualify.

Participants Must:

All participants:

  • Have a body mass index (BMI) ranging from 18.0 to 40.0 kilograms per meter squared (kg/m2)

  • Male participants must agree to use birth control and female participants not of childbearing potential

Healthy participants (Part A):

  • Participants must be overtly healthy, as determined by medical evaluation

Hypertriglyceridemia participants (Parts B, C and D):

  • 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

  • For Part C : Have history of very high triglyceride (lipid) level 500 mg/dL ≤ TG <2000 mg/dL

  • For Part D : Have a history of high triglyceride (lipid) level between 150mg/dL and 500 mg/dL inclusive

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 been tested positive for human immunodeficiency virus (HIV) or hepatitis B or C

  • Be heavy alcohol drinkers or cigarette smokers.

  • For Part C: Participants must not have inflammation of the pancreas

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A clinical trial helps us learn if a new potential medicine or treatment works and how it works. Clinical trials are also called clinical research studies. To learn more about what to expect when taking part in a clinical trial, visit our Clinical Trial Information page.