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A Study of LY3875383 in Healthy Participants and Participants With Hypertriglyceridemia

Primary Purpose

Hypertriglyceridemia

Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
LY3875383
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 Hypertriglyceridemia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: All participants: Have a body mass index (BMI) between 18.5 and 40 kilograms per square meter (kg/m²), inclusive. Males who agree to follow contraceptive requirements, or women not of childbearing potential (WNOCBP). Healthy participants (Part A): • Participants must be overtly healthy, as determined by medical evaluation. For Part B: • Participants must be first-generation Japanese, defined as the participant's biological parents, and all of the participant's biological grandparents must be of exclusive Japanese descent and born in Japan. Hypertriglyceridemia participants (Parts C and D): For Part C: Have history of very high triglyceride (lipid) level 500 mg/dL ≤ TG <2000 mg/dL, which needs to be further confirmed at screening. Participants must be on a lipid-modifying diet and can be on stable lipid-lowering drugs (LLDs) for at least 8 weeks before screening and plan to continue the same throughout the study duration. For Part D: Have history of high triglyceride (lipid) level between 150 mg/dL and 500 mg/dL inclusive at pre-screening or based on medical history and confirmed at screening and Low-density lipoprotein cholesterol (LDL-C) level of ≥40 mg/dL. Participants must be on a stable moderate or high-intensity dose of a statin for at least 8 weeks before screening and plan to continue the same medication and dose throughout the study duration. Exclusion Criteria: All participants: Participants must not be currently participating in or completed a clinical trial within the last 30 days Have donated blood of more than 500 mL within the previous 3 months Have one of the following viral infections: hepatitis B virus, hepatitis C virus or human immunodeficiency virus (HIV). Participants must not be heavy alcohol drinkers or cigarette smokers. For Part C: Have active pancreatitis within the last 6 months

Sites / Locations

  • ProSciento, Inc
  • Altasciences Clinical Los Angeles, Inc
  • Qps-Mra, Llc
  • Endeavor Clinical Trials
  • Lilly Centre for Clinical Pharmacology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Placebo Comparator

Placebo Comparator

Arm Label

LY3875383 (Part A)

LY3875383 (Part B)

LY3875383 (Part C)

LY3875383 (Part D)

Placebo (Part A)

Placebo (Part B)

Placebo (Part C)

Placebo (Part D)

Arm Description

Single-ascending doses of LY3875383 administered subcutaneously (SC).

Single doses of LY3875383 administered SC.

Single doses of LY3875383 administered SC.

Single doses of LY3875383 administered SC.

Placebo administered SC.

Placebo administered SC.

Placebo administered SC.

Placebo administered SC.

Outcomes

Primary Outcome Measures

Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
A summary of TEAEs and SAEs, 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 LY3875383
PK: AUC of LY3875383
PK: Maximum Observed Concentration (Cmax) of LY3875383
PK: Cmax of LY3875383
Part C and D only: Pharmacodynamics (PD): Percentage Change from Baseline in Fasting Triglyceride (TG)
Part C and D only: PD: Percentage Change from Baseline in Fasting TG
Part D only: PD: Percentage Change from Baseline in Fasting Non-High-Density Lipoprotein Cholesterol (HDL-C)
Part D only: PD: Percentage Change from Baseline in Fasting non-HDL-C

Full Information

First Posted
November 4, 2022
Last Updated
October 10, 2023
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT05609825
Brief Title
A Study of LY3875383 in Healthy Participants and Participants With Hypertriglyceridemia
Official Title
A Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3875383 in Healthy Participants and Participants With Hypertriglyceridemia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 14, 2022 (Actual)
Primary Completion Date
January 25, 2024 (Anticipated)
Study Completion Date
January 25, 2024 (Anticipated)

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
The main purpose of this study is to determine the tolerability and side effects related to LY3875383 given as a single injection under the skin to healthy participants and participants with elevated triglyceride (TG) levels.The study will also assess how fast LY3875383 gets into the blood stream and how long the body takes to get rid of it. Each enrolled participant will receive a single dose of either LY3875383 or placebo.The study will be conducted in four parts (A, B, C and D) and may last up to approximately 28 to 56 weeks including screening.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LY3875383 (Part A)
Arm Type
Experimental
Arm Description
Single-ascending doses of LY3875383 administered subcutaneously (SC).
Arm Title
LY3875383 (Part B)
Arm Type
Experimental
Arm Description
Single doses of LY3875383 administered SC.
Arm Title
LY3875383 (Part C)
Arm Type
Experimental
Arm Description
Single doses of LY3875383 administered SC.
Arm Title
LY3875383 (Part D)
Arm Type
Experimental
Arm Description
Single doses of LY3875383 administered SC.
Arm Title
Placebo (Part A)
Arm Type
Placebo Comparator
Arm Description
Placebo administered SC.
Arm Title
Placebo (Part B)
Arm Type
Placebo Comparator
Arm Description
Placebo administered SC.
Arm Title
Placebo (Part C)
Arm Type
Placebo Comparator
Arm Description
Placebo administered SC.
Arm Title
Placebo (Part D)
Arm Type
Placebo Comparator
Arm Description
Placebo administered SC.
Intervention Type
Drug
Intervention Name(s)
LY3875383
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 Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Description
A summary of TEAEs and SAEs, regardless of causality, will be reported in the Reported Adverse Events module
Time Frame
Baseline through Week 53
Secondary Outcome Measure Information:
Title
Pharmacokinetics (PK):Area Under the Concentration Versus Time Curve (AUC) of LY3875383
Description
PK: AUC of LY3875383
Time Frame
Predose up to 72 hours post dose
Title
PK: Maximum Observed Concentration (Cmax) of LY3875383
Description
PK: Cmax of LY3875383
Time Frame
Predose up to 72 hours post dose
Title
Part C and D only: Pharmacodynamics (PD): Percentage Change from Baseline in Fasting Triglyceride (TG)
Description
Part C and D only: PD: Percentage Change from Baseline in Fasting TG
Time Frame
Baseline through up to Week 53
Title
Part D only: PD: Percentage Change from Baseline in Fasting Non-High-Density Lipoprotein Cholesterol (HDL-C)
Description
Part D only: PD: Percentage Change from Baseline in Fasting non-HDL-C
Time Frame
Baseline through Week 53

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All participants: Have a body mass index (BMI) between 18.5 and 40 kilograms per square meter (kg/m²), inclusive. Males who agree to follow contraceptive requirements, or women not of childbearing potential (WNOCBP). Healthy participants (Part A): • Participants must be overtly healthy, as determined by medical evaluation. For Part B: • Participants must be first-generation Japanese, defined as the participant's biological parents, and all of the participant's biological grandparents must be of exclusive Japanese descent and born in Japan. Hypertriglyceridemia participants (Parts C and D): For Part C: Have history of very high triglyceride (lipid) level 500 mg/dL ≤ TG <2000 mg/dL, which needs to be further confirmed at screening. Participants must be on a lipid-modifying diet and can be on stable lipid-lowering drugs (LLDs) for at least 8 weeks before screening and plan to continue the same throughout the study duration. For Part D: Have history of high triglyceride (lipid) level between 150 mg/dL and 500 mg/dL inclusive at pre-screening or based on medical history and confirmed at screening and Low-density lipoprotein cholesterol (LDL-C) level of ≥40 mg/dL. Participants must be on a stable moderate or high-intensity dose of a statin for at least 8 weeks before screening and plan to continue the same medication and dose throughout the study duration. Exclusion Criteria: All participants: Participants must not be currently participating in or completed a clinical trial within the last 30 days Have donated blood of more than 500 mL within the previous 3 months Have one of the following viral infections: hepatitis B virus, hepatitis C virus or human immunodeficiency virus (HIV). Participants must not be heavy alcohol drinkers or cigarette smokers. For Part C: Have active pancreatitis within the last 6 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
ProSciento, Inc
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
Altasciences Clinical Los Angeles, Inc
City
Cypress
State/Province
California
ZIP/Postal Code
90630
Country
United States
Facility Name
Qps-Mra, Llc
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Endeavor Clinical Trials
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Lilly Centre for Clinical Pharmacology
City
Singapore
ZIP/Postal Code
138623
Country
Singapore

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://trials.lilly.com/en-US/trial/366875
Description
A Study of LY3875383 in Healthy Participants and Participants With Hypertriglyceridemia

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