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A Study of LY3475766 in Healthy Participants

Primary Purpose

Dyslipidemias

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

LY3475766 - IV

LY3475766 - SC

Placebo - IV

Placebo - SC

About this trial

This is an interventional basic science trial for Dyslipidemias

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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Have previously completed or withdrawn from this study or any other study investigating LY3475766, and have previously received the investigational product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

Sites / Locations

WCCT Global
Covance Clinical Research Inc
Covance Dallas
Covance Clinical Research Inc

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

LY3475766 - IV

Placebo - IV

LY3475766 - SC

Placebo - SC

Arm Description

LY3475766 administered intravenously (IV) to participants with dyslipidemia

Placebo administered IV to participants with dyslipidemia

LY3475766 administered subcutaneously (SC) to participants with dyslipidemia

Placebo administered SC to participants with dyslipidemia

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3475766

PK: AUC of LY3475766

PK: Maximum Observed Drug Concentration (Cmax) of LY3475766

PK: Cmax of LY3475766

PK: Time to Maximum Observed Drug Concentration (Tmax) of LY3475766

PK: Tmax of LY3475766

Pharmacodynamics (PD): Percent Change from Baseline in Triglycerides (TG)

PD: Percent Change from Baseline in TG

PD: Percent Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)

PD: Percent Change from Baseline in LDL-C

PD: Percent Change from Baseline in Apolipoprotein B (ApoB)

PD: Percent Change from Baseline in ApoB

Full Information

NCT ID

NCT04052594

First Posted

August 8, 2019

Last Updated

April 27, 2021

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT04052594

Brief Title

A Study of LY3475766 in Healthy Participants

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 15, 2021

Overall Recruitment Status

Completed

Study Start Date

September 3, 2019 (Actual)

Primary Completion Date

March 31, 2021 (Actual)

Study Completion Date

March 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dyslipidemias

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LY3475766 - IV

Arm Type

Experimental

Arm Description

LY3475766 administered intravenously (IV) to participants with dyslipidemia

Arm Title

Placebo - IV

Arm Type

Placebo Comparator

Arm Description

Placebo administered IV to participants with dyslipidemia

Arm Title

LY3475766 - SC

Arm Type

Experimental

Arm Description

LY3475766 administered subcutaneously (SC) to participants with dyslipidemia

Arm Title

Placebo - SC

Arm Type

Placebo Comparator

Arm Description

Placebo administered SC to participants with dyslipidemia

Intervention Type

Drug

Intervention Name(s)

LY3475766 - IV

Intervention Description

Administered IV

Intervention Type

Drug

Intervention Name(s)

LY3475766 - SC

Intervention Description

Administered SC

Intervention Type

Drug

Intervention Name(s)

Placebo - IV

Intervention Description

Administered IV

Intervention Type

Drug

Intervention Name(s)

Placebo - SC

Intervention Description

Administered SC

Primary Outcome Measure Information:

Title

Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

Description

A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Time Frame

Baseline up to Day 85

Secondary Outcome Measure Information:

Title

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3475766

Description

PK: AUC of LY3475766

Time Frame

Predose up to Day 85

Title

PK: Maximum Observed Drug Concentration (Cmax) of LY3475766

Description

PK: Cmax of LY3475766

Time Frame

Predose up to Day 85

Title

PK: Time to Maximum Observed Drug Concentration (Tmax) of LY3475766

Description

PK: Tmax of LY3475766

Time Frame

Predose up to Day 85

Title

Pharmacodynamics (PD): Percent Change from Baseline in Triglycerides (TG)

Description

PD: Percent Change from Baseline in TG

Time Frame

Baseline, Day 85

Title

PD: Percent Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)

Description

PD: Percent Change from Baseline in LDL-C

Time Frame

Baseline, Day 85

Title

PD: Percent Change from Baseline in Apolipoprotein B (ApoB)

Description

PD: Percent Change from Baseline in ApoB

Time Frame

Baseline, Day 85

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

WCCT Global

City

Cypress

State/Province

California

ZIP/Postal Code

90630

Country

United States

Facility Name

Covance Clinical Research Inc

City

Daytona Beach

State/Province

Florida

ZIP/Postal Code

32117

Country

United States

Facility Name

Covance Dallas

City

Dallas

State/Province

Texas

ZIP/Postal Code

75247

Country

United States

Facility Name

Covance Clinical Research Inc

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53704

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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A Study of LY3475766 in Healthy Participants

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