A Study of LY3873862 in Healthy Participants

A Single Ascending and Multiple Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3873862 in Healthy Participants

The main purpose of this study is to evaluate the safety and tolerability of LY3873862 when administered either in single or multiple doses in healthy participants. The study will also assess how fast LY3873862 gets into the blood stream and how long it takes the body to remove it. The study is open to healthy participants. The study will last up to approximately 58, 72, and 72 days for Part A, B, and C, respectively.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: LY3873862

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, NW10 7EW
    • Hammersmith Medicines Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Participants who are overtly healthy as determined by medical evaluation
• Body mass index (BMI) within the range 18.0 to 32.0 kilograms per meter squared (kg/m²)
• Are male or female participants, including those of childbearing potential

Exclusion Criteria:

• Have a history or presence of medical illness including, but not limited to, any cardiovascular, renal, hepatic, gastrointestinal, respiratory, hematologic, endocrine, psychiatric, or neurological disease, convulsions, or any clinically significant laboratory abnormality that, in the judgment of the investigator, indicate a medical problem that would preclude study participation.
• Are unwilling to comply with the dietary restrictions required for this study, including the avoidance by 5 days prior to study drug administration until the final ambulatory visit the ingestion of fruits, sauces, and juices containing furanocoumarins that irreversibly inhibit cytochrome P450 (CYP)3A4. The following fruits, sauces, and juices are excluded: grapefruit, Seville oranges, pomelos, cranberry, Goji berry, and apple.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo (Part A); Placebo administered orally.	Drug: Placebo; Administered orally.
Experimental: LY3873862 (Part A); LY3873862 administered orally as single dose.	Drug: LY3873862; Administered orally.
Experimental: LY3873862 (Part B); LY3873862 administered orally as multiple doses.	Drug: LY3873862; Administered orally.
Placebo Comparator: Placebo (Part B); Placebo administered orally.	Drug: Placebo; Administered orally.
Experimental: LY3873862 (Part C); LY3873862 administered orally as multiple doses.	Drug: LY3873862; Administered orally.
Placebo Comparator: Placebo (Part C); Placebo administered orally.	Drug: Placebo; Administered orally.

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, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module	Baseline through 72 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3873862	PK: AUC[0-∞] of LY3873862	Predose up to 96 hours postdose
PK: Area Under the Concentration versus Time Curve at Steady State (AUCτ) of LY3873862	PK: (AUCτ) of LY3873862	Predose up to 96 hours postdose
PK: Maximum Observed Concentration (Cmax) of LY3873862	PK: Cmax of LY3873862	Predose up to 96 hours postdose
PK: Time of Maximum observed Concentration (Tmax) of LY3873862	PK: Tmax of LY3873862	Predose up to 96 hours postdose

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

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2022
• Primary Completion (Actual): April 29, 2025
• Study Completion (Actual): April 29, 2025

Study Registration Dates

• First Submitted: August 5, 2022
• First Submitted That Met QC Criteria: August 5, 2022
• First Posted (Actual): August 8, 2022

Study Record Updates

• Last Update Posted (Actual): May 11, 2025
• Last Update Submitted That Met QC Criteria: May 8, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 18445; J3X-MC-LYGA (Other Identifier: Eli Lilly and Company); 2022-000500-36 (EudraCT Number)

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: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No