A Study of LY3561774 in Participants With Dyslipidemia

Eli Lilly and Company74 enrolled

Overview

This is a 3-part study. In Parts A and B, the main purpose is to evaluate the safety and tolerability of the study drug known as LY3561774 in participants with dyslipidemia (high blood fat levels). How the body processes the study drug and the effect of the study drug on blood fat levels will also be investigated. Part C will mainly evaluate the safety and tolerability of LY3561774 as well as how the body processes the study drug in Japanese participants. The study may last up 52, 56 and 28 weeks for each participant in Parts A, B and C, respectively. There are up to 22, 26 and 16 visits in Parts A, B and C, respectively.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Dyslipidemias

Interventions

LY3561774DRUG

Administered SC.

PlaceboDRUG

Administered SC.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * For Parts A and B, have a fasting triglyceride (TG) level greater than or equal to (≥) 150 milligram/deciliter (mg/dL) and less than 500 mg/dL, as well as low density lipoprotein cholesterol (LDL-C) level greater than or equal to (≥) 70 mg/dL * For Part C, participants should be first-generation Japanese origin. * Have a body mass index (BMI) of 18.5 to 40.0 kilograms per square meter (kg/m²) * Male participants must agree to adhere to contraception restrictions and female participants must not be able to get pregnant Exclusion Criteria: * Have taken any prescription medications that are for lowering serum TGs within the past 2 months (use of statins is allowed if the dose has been stable for 8 weeks) * Have Type 1 diabetes * Are currently participating in or completed a clinical trial within the last 30 days * Are heavy alcohol drinkers or heavy cigarette smokers * Have donated blood of more than 500 millilitres (mL) in the last 3 months

Locations (5)

Altasciences Clinical Los Angeles, Inc

Cypress, California, United States

Collaborative Neuroscience Research, LLC

Long Beach, California, United States

Qps-Mra, Llc

South Miami, Florida, United States

Hassman Research Institute

Marlton, New Jersey, United States

Outcomes

Primary Outcomes

Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

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 Week 53

Secondary Outcomes

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of LY3561774

PK: AUC\[0-tlast\] of LY3561774

Time frame: Predose through Day 8

PK: Maximum Observed Drug Concentration (Cmax) of LY3561774

PK: Cmax of LY3561774

Time frame: Predose through Day 8

PK: Time of Maximum Observed Concentration (Tmax) of LY3561774

PK: Tmax of LY3561774

Time frame: Predose through Day 8

PD: Change From Baseline in Fasting Triglyceride (TG) and low-density lipoprotein cholesterol (LDL-C)

PD: Change From Baseline in Fasting TG and LDL-C

Time frame: Predose through Week 53

Data from ClinicalTrials.gov

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