A Study of LY3875383 in Healthy Participants and Participants With Hypertriglyceridemia

Hypertriglyceridemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05609825
• Other study ID #: 18537
• Secondary ID: J4D-MC-EZFA
• Status: Completed
• Phase: Phase 1
• Start date: November 14, 2022
• Est. completion date: January 10, 2024

Study information

• Verified date: March 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: January 10, 2024
• Est. primary completion date: January 10, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertriglyceridemia

Intervention

Drug:
• LY3875383
Administered SC.
• Placebo
Administered SC.

Locations

Country	Name	City	State
Singapore	Lilly Centre for Clinical Pharmacology	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pharmacokinetics (PK):Area Under the Concentration Versus Time Curve (AUC) of LY3875383	PK: AUC of LY3875383	Predose up to 72 hours post dose
Secondary	PK: Maximum Observed Concentration (Cmax) of LY3875383	PK: Cmax of LY3875383	Predose up to 72 hours post dose
Secondary	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
Secondary	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

External Links

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