A Study of LY3561774 in Participants With Dyslipidemia

Lilly

Status and phase: Completed; Phase 1

Conditions: Dyslipidemias

Treatments: Drug: LY3561774; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04644809

17825

J3F-MC-EZCA (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 74 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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74 participants in 4 patient groups, including a placebo group

LY3561774 (Part A)

Experimental group

Description:

Single ascending doses of LY3561774 administered subcutaneously (SC).

Treatment:

Drug: LY3561774

LY3561774 (Part B)

Experimental group

Description:

Repeat doses of LY3561774 administered SC.

Treatment:

Drug: LY3561774

LY3561774 (Part C)

Experimental group

Description:

Single doses of LY3561774 administered SC in Japanese Participants.

Treatment:

Drug: LY3561774

Placebo (Part A, B & C)

Placebo Comparator group

Description:

Placebo administered SC.

Treatment:

Drug: Placebo