A Study of LY3561774 in Participants With Dyslipidemia

Study Overview
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Brief Summary
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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.

Official Title
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A Single-Ascending and Repeat-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3561774

Conditions
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Dyslipidemias

Intervention / Treatment
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* Drug: LY3561774
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3561774 (Part A)<br>Single ascending doses of LY3561774 administered subcutaneously (SC). | Drug: LY3561774<br>* Administered SC.<br>|
| Experimental: LY3561774 (Part B)<br>Repeat doses of LY3561774 administered SC. | Drug: LY3561774<br>* Administered SC.<br>|
| Experimental: LY3561774 (Part C)<br>Single doses of LY3561774 administered SC in Japanese Participants. | Drug: LY3561774<br>* Administered SC.<br>|
| Placebo Comparator: Placebo (Part A, B & C)<br>Placebo administered SC. | Drug: Placebo<br>* Administered SC.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline up to Week 53 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Predose through Day 8 | 
| PK: Maximum Observed Drug Concentration (Cmax) of LY3561774 | PK: Cmax of LY3561774 | Predose through Day 8 | 
| PK: Time of Maximum Observed Concentration (Tmax) of LY3561774 | PK: Tmax of LY3561774 | 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 | Predose through Week 53 |