A Study of LY3561774 in Participants With Dyslipidemia

Phase 1

Completed

• Conditions: Dyslipidemias
• Interventions: Drug: LY3561774; Drug: Placebo

• Registration Number: NCT04644809
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-24
• Study First Submitted QC: 2020-11-24
• Study First Posted: 2020-11-25
• Study Start: 2020-11-30
• Primary Completion: 2022-05-17
• Study Completion: 2022-05-17
• Status Verified: 2022-08-01
• Last Update Submitted: 2022-08-09
• Last Update Posted: 2022-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
LY3561774 (Part A)	LY3561774	Single ascending doses of LY3561774 administered subcutaneously (SC).
LY3561774 (Part B)	LY3561774	Repeat doses of LY3561774 administered SC.
LY3561774 (Part C)	LY3561774	Single doses of LY3561774 administered SC in Japanese Participants.
Placebo (Part A, B & C)	Placebo	Placebo administered SC.

Primary Outcome Measures

Name	Time	Method
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	Baseline up to Week 53	A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Secondary Outcome Measures

Name	Time	Method
PK: Time of Maximum Observed Concentration (Tmax) of LY3561774	Predose through Day 8	PK: Tmax of LY3561774
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of LY3561774	Predose through Day 8	PK: AUC\[0-tlast\] of LY3561774
PK: Maximum Observed Drug Concentration (Cmax) of LY3561774	Predose through Day 8	PK: Cmax of LY3561774
PD: Change From Baseline in Fasting Triglyceride (TG) and low-density lipoprotein cholesterol (LDL-C)	Predose through Week 53	PD: Change From Baseline in Fasting TG and LDL-C

Trial Locations

Locations (5)

Alliance for Multispecialty Research, LLC; 🇺🇸 Knoxville, Tennessee, United States

Collaborative Neuroscience Research, LLC; 🇺🇸 Long Beach, California, United States

Altasciences Clinical Los Angeles, Inc; 🇺🇸 Cypress, California, United States

Hassman Research Institute; 🇺🇸 Marlton, New Jersey, United States

Qps-Mra, Llc; 🇺🇸 South Miami, Florida, United States