A Study of LY3475766 in Healthy Participants

Dyslipidemias Clinical Trial

Official title:

A Randomized, Double-Blind, Single Dose, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3475766

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04052594
• Other study ID #: 17394
• Secondary ID: J1T-MC-GZEA
• Status: Completed
• Phase: Phase 1
• Start date: September 3, 2019
• Est. completion date: March 31, 2021

Study information

• Verified date: April 15, 2021
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the safety and tolerability of LY3475766 when given to participants with high levels of blood fat called triglycerides. It will also investigate how the body processes the study drug and the effect of the study drug on the body. Information about any side effects will be documented. This study will last up to 16 weeks for each participant.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Are overtly healthy males or females, apart from dyslipidemia

• Male participants must agree to adhere to contraception restrictions

• Female participants must be of nonchildbearing potential and include those who are infertile due to surgical sterilization or those who are postmenopausal

• Have a body mass index (BMI) >18.5 and <40 kilograms per meter squared (kg/m²)

• Have clinical laboratory test results within normal reference range, or acceptable deviations per investigator discretion

• Have a fasting triglyceride (TG) level that is 135 to 499 milligrams per deciliter (mg/dL), inclusive, at both screening and Day -1

• Have a fasting low density lipoprotein cholesterol (LDL-C) level greater than or equal to (=) 70 mg/dL, inclusive, at screening and Day -1

• Have had a stable body weight for the 3 months prior to randomization (<5% body weight change)

• Have not modified diet or adopted any nutritional lifestyle modification within 3 months prior to randomization

Exclusion Criteria:

• Are taking or have started taking Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors within 3 months prior to randomization; or statins, fibrates, or niacin =1000 mg/day within 8 weeks prior to randomization; or niacin >1000 milligrams per day (mg/day) within 16 weeks prior to randomization; or any other lipid-lowering agents within 1 month prior to randomization

• Are taking or have started taking a beta-blocker, antiarrhythmic, non-dihydropyridine calcium channel blocker, ivabradine, or any other heart rate lowering agent within 1 month or 5 half-lives prior to randomization, whichever is longer

• Have a diagnosis of diabetes mellitus (type 1 diabetes mellitus or type 2 diabetes mellitus) or have 1 of the following at screening: fasting plasma glucose concentration =126 mg/dL (7.0 millimoles per liter [mmol/L]) OR a glycated hemoglobin level =6.5% (48 millimoles per mole [mmol/mol])

• Have previously completed or withdrawn from this study or any other study investigating LY3475766, and have previously received the investigational product

• Have known allergies to LY3475766, related compounds, or any components of the formulation, or history of significant atopy

• Have a seated heart rate =50 beats per minute

• Have clinically significant abnormal electrocardiogram (ECG) results constituting a risk while taking the investigational product, as determined by the investigator

• Have an abnormal blood pressure (BP) as determined by the investigator

Related Conditions & MeSH terms

• Dyslipidemias

Intervention

Drug:
• LY3475766 - IV
Administered IV
• LY3475766 - SC
Administered SC
• Placebo - IV
Administered IV
• Placebo - SC
Administered SC

Locations

Country	Name	City	State
United States	WCCT Global	Cypress	California
United States	Covance Dallas	Dallas	Texas
United States	Covance Clinical Research Inc	Daytona Beach	Florida
United States	Covance Clinical Research Inc	Madison	Wisconsin

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 Day 85
Secondary	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3475766	PK: AUC of LY3475766	Predose up to Day 85
Secondary	PK: Maximum Observed Drug Concentration (Cmax) of LY3475766	PK: Cmax of LY3475766	Predose up to Day 85
Secondary	PK: Time to Maximum Observed Drug Concentration (Tmax) of LY3475766	PK: Tmax of LY3475766	Predose up to Day 85
Secondary	Pharmacodynamics (PD): Percent Change from Baseline in Triglycerides (TG)	PD: Percent Change from Baseline in TG	Baseline, Day 85
Secondary	PD: Percent Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)	PD: Percent Change from Baseline in LDL-C	Baseline, Day 85
Secondary	PD: Percent Change from Baseline in Apolipoprotein B (ApoB)	PD: Percent Change from Baseline in ApoB	Baseline, Day 85