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A Study of LY3561774 in Participants With Dyslipidemia

Primary Purpose

Dyslipidemias

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
LY3561774
Placebo
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

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:

  • 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

Sites / Locations

  • Altasciences Clinical Los Angeles, Inc
  • Collaborative Neuroscience Research, LLC
  • Qps-Mra, Llc
  • Hassman Research Institute
  • Alliance for Multispecialty Research, LLC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

LY3561774 (Part A)

LY3561774 (Part B)

LY3561774 (Part C)

Placebo (Part A, B & C)

Arm Description

Single ascending doses of LY3561774 administered subcutaneously (SC).

Repeat doses of LY3561774 administered SC.

Single doses of LY3561774 administered SC in Japanese Participants.

Placebo administered SC.

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 from Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of LY3561774
PK: AUC[0-tlast] of LY3561774
PK: Maximum Observed Drug Concentration (Cmax) of LY3561774
PK: Cmax of LY3561774
PK: Time of Maximum Observed Concentration (Tmax) of LY3561774
PK: Tmax of LY3561774
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

Full Information

First Posted
November 24, 2020
Last Updated
August 9, 2022
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT04644809
Brief Title
A Study of LY3561774 in Participants With Dyslipidemia
Official Title
A Single-Ascending and Repeat-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3561774
Study Type
Interventional

2. Study Status

Record Verification Date
August 1, 2022
Overall Recruitment Status
Completed
Study Start Date
November 30, 2020 (Actual)
Primary Completion Date
May 17, 2022 (Actual)
Study Completion Date
May 17, 2022 (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
No
Data Monitoring Committee
No

5. Study Description

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.

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
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LY3561774 (Part A)
Arm Type
Experimental
Arm Description
Single ascending doses of LY3561774 administered subcutaneously (SC).
Arm Title
LY3561774 (Part B)
Arm Type
Experimental
Arm Description
Repeat doses of LY3561774 administered SC.
Arm Title
LY3561774 (Part C)
Arm Type
Experimental
Arm Description
Single doses of LY3561774 administered SC in Japanese Participants.
Arm Title
Placebo (Part A, B & C)
Arm Type
Placebo Comparator
Arm Description
Placebo administered SC.
Intervention Type
Drug
Intervention Name(s)
LY3561774
Intervention Description
Administered SC.
Intervention Type
Drug
Intervention Name(s)
Placebo
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 Week 53
Secondary Outcome Measure Information:
Title
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of LY3561774
Description
PK: AUC[0-tlast] of LY3561774
Time Frame
Predose through Day 8
Title
PK: Maximum Observed Drug Concentration (Cmax) of LY3561774
Description
PK: Cmax of LY3561774
Time Frame
Predose through Day 8
Title
PK: Time of Maximum Observed Concentration (Tmax) of LY3561774
Description
PK: Tmax of LY3561774
Time Frame
Predose through Day 8
Title
PD: Change From Baseline in Fasting Triglyceride (TG) and low-density lipoprotein cholesterol (LDL-C)
Description
PD: Change From Baseline in Fasting TG and LDL-C
Time Frame
Predose through Week 53

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
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
Altasciences Clinical Los Angeles, Inc
City
Cypress
State/Province
California
ZIP/Postal Code
90630
Country
United States
Facility Name
Collaborative Neuroscience Research, LLC
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Qps-Mra, Llc
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Hassman Research Institute
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Facility Name
Alliance for Multispecialty Research, LLC
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/6o9PZPIhCp7DEVhxSrEnhY
Description
A Study of LY3561774 in Participants With Dyslipidemia

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