A Study of LY4060874 in Healthy Participants

A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY4060874 in Healthy Participants

The purpose of this study is to evaluate safety and tolerability of LY4060874 in healthy participants.

Study participation may last up to 22 weeks and up to approximately 18 study visits.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: Placebo; Drug: Placebo; Drug: LY4060874; Drug: LY4060874

• Study Type: Interventional
• Enrollment (Actual): 121
• Phase: Phase 1

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 138623
    • Lilly Centre for Clinical Pharmacology
• United States
  • Texas
    • Dallas, Texas, United States, 75247
      • Fortrea, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Are overtly healthy as determined by medical evaluation, including medical history and physical examination.
• Have a body mass index in the range of 20 to 29.9 kilogram per meter squared (kg/m²), inclusive, at screening.
• To qualify as Chinese for this study, all 4 of the participant's biological grandparents must be of exclusive Chinese descent and born in China.
• To qualify as a participant of first-generation Japanese origin, the participant, the participant's biological parents, and all the participants' biological grandparents must be of exclusive Japanese descent and born in Japan.

Exclusion Criteria:

• Have a history of or have been diagnosed with Type 1 or Type 2 diabetes mellitus.
• Have hemoglobin A1c (HbA1c) > 6.4% or 46 millimoles/mole (mmol/mol) at screening.
• Have taken approved, including over the counter (OTC) or prescribed, medication or investigational medication for weight loss, including GLP-1 receptor agonists, within the previous 3 months of study screening.
• Have had surgical treatment for obesity.
• Are actively participating in a weight loss program or intend to initiate an intensive diet and/or exercise program during the study.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LY4060874 (Part A Subcutaneous); Single ascending dose of LY4060874 administered subcutaneously (SC).	Drug: LY4060874; Administered SC; Drug: LY4060874; Administered IV
Experimental: LY4060874 (Part A Intravenous); Single ascending dose of LY4060874 administered intravenously (IV).	Drug: LY4060874; Administered SC; Drug: LY4060874; Administered IV
Experimental: LY4060874 (Part B); Multiple ascending doses of LY4060874 administered SC.	Drug: LY4060874; Administered SC; Drug: LY4060874; Administered IV
Experimental: LY4060874 (Part B Chinese); Multiple ascending doses of LY4060874 administered SC in Chinese participants.	Drug: LY4060874; Administered SC; Drug: LY4060874; Administered IV
Experimental: LY4060874 (Part C Japanese); Multiple ascending doses of LY4060874 administered SC in Japanese participants.	Drug: LY4060874; Administered SC; Drug: LY4060874; Administered IV
Placebo Comparator: Placebo (SC); Placebo administered SC in Part A, B, and C.	Drug: Placebo; Administered SC; Drug: Placebo; Administered IV
Placebo Comparator: Placebo (IV); Placebo administered IV in Part A.	Drug: Placebo; Administered SC; Drug: Placebo; Administered IV

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 Events (SAEs)	Number of participants with one or more TEAEs and SAEs.	Baseline up to 22 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK): Area Under the Concentration Versus Time (AUC) of LY4060874	PK: Area Under the Concentration Versus Time (AUC) of LY4060874	PK: Part A: Baseline up to 13 weeks; Part B and C: Baseline up to 18 weeks
PK: Maximum Observed Concentration of LY4060874	PK: Cmax of LY4060874	PK: Part A: Baseline up to 13 weeks; Part B and C: Baseline up to 18 weeks

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: 1-877-CTLILLY (1-877-285-4559) or 3176154559 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): December 2, 2024
• Primary Completion (Actual): February 20, 2026
• Study Completion (Actual): February 20, 2026

Study Registration Dates

• First Submitted: November 26, 2024
• First Submitted That Met QC Criteria: November 26, 2024
• First Posted (Actual): November 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: 27300; J5X-MC-YJAA (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