A Study of LY3875383 in Healthy Participants and Participants With Hypertriglyceridemia

A Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3875383 in Healthy Participants and Participants With Hypertriglyceridemia

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.

Study Overview

• Status: Completed
• Conditions: Hypertriglyceridemia
• Intervention / Treatment: Drug: Placebo; Drug: LY3875383

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or; Phone Number: 1-317-615-4559; Email: ClinicalTrials.gov@lilly.com

Study Locations

• Singapore
  • Singapore, Singapore, 138623
    • Lilly Centre for Clinical Pharmacology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo (Part A); Placebo administered SC.	Drug: Placebo; Administered SC.
Placebo Comparator: Placebo (Part B); Placebo administered SC.	Drug: Placebo; Administered SC.
Experimental: LY3875383 (Part A); Single-ascending doses of LY3875383 administered subcutaneously (SC).	Drug: LY3875383; Administered SC.
Experimental: LY3875383 (Part B); Single doses of LY3875383 administered SC.	Drug: LY3875383; Administered SC.
Experimental: LY3875383 (Part C); Single doses of LY3875383 administered SC.	Drug: LY3875383; Administered SC.
Experimental: LY3875383 (Part D); Single doses of LY3875383 administered SC.	Drug: LY3875383; Administered SC.
Placebo Comparator: Placebo (Part C); Placebo administered SC.	Drug: Placebo; Administered SC.
Placebo Comparator: Placebo (Part D); Placebo administered SC.	Drug: Placebo; Administered SC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline through Week 53

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK):Area Under the Concentration Versus Time Curve (AUC) of LY3875383	PK: AUC of LY3875383	Predose up to 72 hours post dose
PK: Maximum Observed Concentration (Cmax) of LY3875383	PK: Cmax of LY3875383	Predose up to 72 hours post dose
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	Baseline through up to Week 53
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	Baseline through Week 53

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: 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), Eli Lilly and Company

Publications and helpful links

Helpful Links

• A Study of LY3875383 in Healthy Participants and Participants With Hypertriglyceridemia

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2022
• Primary Completion (Actual): January 10, 2024
• Study Completion (Actual): January 10, 2024

Study Registration Dates

• First Submitted: November 4, 2022
• First Submitted That Met QC Criteria: November 4, 2022
• First Posted (Actual): November 8, 2022

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypertriglyceridemia
• Other Study ID Numbers: 18537; J4D-MC-EZFA (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