A Study of LY3561774 in Participants With Dyslipidemia

Dyslipidemias Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04644809
• Other study ID #: 17825
• Secondary ID: J3F-MC-EZCA
• Status: Completed
• Phase: Phase 1
• Start date: November 30, 2020
• Est. completion date: May 17, 2022

Study information

• Verified date: August 1, 2022
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: May 17, 2022
• Est. primary completion date: May 17, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemias

Intervention

Drug:
• LY3561774
Administered SC.
• Placebo
Administered SC.

Locations

Country	Name	City	State
United States	Altasciences Clinical Los Angeles, Inc	Cypress	California
United States	Alliance for Multispecialty Research, LLC	Knoxville	Tennessee
United States	Collaborative Neuroscience Research, LLC	Long Beach	California
United States	Hassman Research Institute	Marlton	New Jersey
United States	Qps-Mra, Llc	South Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	PK: Maximum Observed Drug Concentration (Cmax) of LY3561774	PK: Cmax of LY3561774	Predose through Day 8
Secondary	PK: Time of Maximum Observed Concentration (Tmax) of LY3561774	PK: Tmax of LY3561774	Predose through Day 8
Secondary	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

External Links

•   A Study of LY3561774 in Participants With Dyslipidemia