A Study of LY3475766 in Healthy Participants

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

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.

Study Overview

• Status: Completed
• Conditions: Dyslipidemias
• Intervention / Treatment: Drug: Placebo - SC; Drug: Placebo - IV; Drug: LY3475766 - IV; Drug: LY3475766 - SC

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Cypress, California, United States, 90630
      • WCCT Global
  • Florida
    • Daytona Beach, Florida, United States, 32117
      • Covance Clinical Research Inc
  • Texas
    • Dallas, Texas, United States, 75247
      • Covance Dallas
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Covance Clinical Research Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LY3475766 - IV; LY3475766 administered intravenously (IV) to participants with dyslipidemia	Drug: LY3475766 - IV; Administered IV
Placebo Comparator: Placebo - IV; Placebo administered IV to participants with dyslipidemia	Drug: Placebo - IV; Administered IV
Experimental: LY3475766 - SC; LY3475766 administered subcutaneously (SC) to participants with dyslipidemia	Drug: LY3475766 - SC; Administered SC
Placebo Comparator: Placebo - SC; Placebo administered SC to participants with dyslipidemia	Drug: Placebo - SC; Administered SC

What is the study measuring?

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 Day 85

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2019
• Primary Completion (Actual): March 31, 2021
• Study Completion (Actual): March 31, 2021

Study Registration Dates

• First Submitted: August 8, 2019
• First Submitted That Met QC Criteria: August 8, 2019
• First Posted (Actual): August 12, 2019

Study Record Updates

• Last Update Posted (Actual): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 27, 2021
• Last Verified: April 15, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias
• Other Study ID Numbers: 17394; J1T-MC-GZEA (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No