NCT06709820

Brief Summary

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.

Trial Health

58
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
132

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Dec 2024

Geographic Reach
2 countries

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 29, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

December 2, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

March 3, 2026

Status Verified

March 1, 2026

Enrollment Period

1.2 years

First QC Date

November 26, 2024

Last Update Submit

March 2, 2026

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Pharmacokinetics (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: Part A: Baseline up to 13 weeks; Part B and C: Baseline up to 18 weeks

Study Arms (7)

LY4060874 (Part A Subcutaneous)

EXPERIMENTAL

Single ascending dose of LY4060874 administered subcutaneously (SC).

Drug: LY4060874

LY4060874 (Part A Intravenous)

EXPERIMENTAL

Single ascending dose of LY4060874 administered intravenously (IV).

Drug: LY4060874

LY4060874 (Part B)

EXPERIMENTAL

Multiple ascending doses of LY4060874 administered SC.

Drug: LY4060874

LY4060874 (Part B Chinese)

EXPERIMENTAL

Multiple ascending doses of LY4060874 administered SC in Chinese participants.

Drug: LY4060874

LY4060874 (Part C Japanese)

EXPERIMENTAL

Multiple ascending doses of LY4060874 administered SC in Japanese participants.

Drug: LY4060874

Placebo (SC)

PLACEBO COMPARATOR

Placebo administered SC in Part A, B, and C.

Drug: Placebo

Placebo (IV)

PLACEBO COMPARATOR

Placebo administered IV in Part A.

Drug: Placebo

Interventions

LY4060874DRUG

Administered SC

LY4060874 (Part A Subcutaneous)LY4060874 (Part B Chinese)LY4060874 (Part B)LY4060874 (Part C Japanese)
PlaceboDRUG

Administered SC

Placebo (SC)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fortrea, Inc.

Dallas, Texas, 75247, United States

Location

Lilly Centre for Clinical Pharmacology

Singapore, 138623, Singapore

Location

Study Officials

  • 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 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 26, 2024

First Posted

November 29, 2024

Study Start

December 2, 2024

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

March 3, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)US(1)