A Study of LY3875383 in Healthy Participants and Participants With Hypertriglyceridemia

NCT05609825 | Terminated Phase 1 FDA Drug

• 2 other identifiers: 18537J4D-MC-EZFA
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertriglyceridemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Pharmacokinetics (PK):Area Under the Concentration Versus Time Curve (AUC) of LY3875383

  Predose up to Day 8 post dose

• PK: Maximum Observed Concentration (Cmax) of LY3875383

  Predose up to Day 8 post dose

• Part C and D only: Pharmacodynamics (PD): Percentage Change from Baseline in Fasting Triglyceride (TG)

  Baseline through up to Week 53

• Part D only: PD: Percentage Change from Baseline in Fasting Non-High-Density Lipoprotein Cholesterol (HDL-C)

  Baseline through Week 53

Study Arms (8)

LY3875383 (Part A)

EXPERIMENTAL

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

Drug: LY3875383

LY3875383 (Part B)

EXPERIMENTAL

Single doses of LY3875383 administered SC.

Drug: LY3875383

LY3875383 (Part C)

EXPERIMENTAL

Single doses of LY3875383 administered SC.

Drug: LY3875383

LY3875383 (Part D)

EXPERIMENTAL

Single doses of LY3875383 administered SC.

Drug: LY3875383

Placebo (Part A)

PLACEBO COMPARATOR

Placebo administered SC.

Drug: Placebo

Placebo (Part B)

PLACEBO COMPARATOR

Placebo administered SC.

Drug: Placebo

Placebo (Part C)

PLACEBO COMPARATOR

Placebo administered SC.

Drug: Placebo

Placebo (Part D)

PLACEBO COMPARATOR

Placebo administered SC.

Drug: Placebo

Interventions

LY3875383 DRUG

Administered SC.

LY3875383 (Part A); LY3875383 (Part B); LY3875383 (Part C); LY3875383 (Part D)

Placebo DRUG

Administered SC.

Placebo (Part A); Placebo (Part B); Placebo (Part C); Placebo (Part D)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Lilly Centre for Clinical Pharmacology

Singapore, 138623, Singapore

Location

Related Links

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

MeSH Terms

Conditions

Hypertriglyceridemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: November 8, 2022
• Study Start: November 14, 2022
• Primary Completion: January 10, 2024
• Study Completion: January 10, 2024
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)