A Study of LY3875383 in Healthy Participants and Participants With Hypertriglyceridemia

Phase 1

Completed

• Conditions: Hypertriglyceridemia
• Interventions: Drug: LY3875383; Drug: Placebo

• Registration Number: NCT05609825
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-04
• Study First Submitted QC: 2022-11-04
• Study First Posted: 2022-11-08
• Study Start: 2022-11-14
• Primary Completion: 2024-01-10
• Study Completion: 2024-01-10
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-19
• Last Update Posted: 2025-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3875383 (Part A)	LY3875383	Single-ascending doses of LY3875383 administered subcutaneously (SC).
LY3875383 (Part B)	LY3875383	Single doses of LY3875383 administered SC.
Placebo (Part A)	Placebo	Placebo administered SC.
Placebo (Part B)	Placebo	Placebo administered SC.
Placebo (Part C)	Placebo	Placebo administered SC.
Placebo (Part D)	Placebo	Placebo administered SC.
LY3875383 (Part C)	LY3875383	Single doses of LY3875383 administered SC.
LY3875383 (Part D)	LY3875383	Single doses of LY3875383 administered SC.

Primary Outcome Measures

Name	Time	Method
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	Baseline through Week 53	A summary of TEAEs and SAEs, regardless of causality, will be reported in the Reported Adverse Events module

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK):Area Under the Concentration Versus Time Curve (AUC) of LY3875383	Predose up to Day 8 post dose	PK: AUC of LY3875383
PK: Maximum Observed Concentration (Cmax) of LY3875383	Predose up to Day 8 post dose	PK: Cmax of LY3875383
Part C and D only: Pharmacodynamics (PD): Percentage Change from Baseline in Fasting Triglyceride (TG)	Baseline through up to Week 53	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)	Baseline through Week 53	Part D only: PD: Percentage Change from Baseline in Fasting non-HDL-C

Trial Locations

Locations (1)

Lilly Centre for Clinical Pharmacology; 🇸🇬 Singapore, Singapore