A Study of LY4060874 in Healthy Participants

Phase 1

Not yet recruiting

• Conditions: Healthy Participants
• Interventions: Drug: LY4060874; Drug: Placebo

• Registration Number: NCT06709820
• Lead Sponsor: Eli Lilly and Company

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 16 study visits.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-26
• Study First Submitted QC: 2024-11-26
• Last Update Submitted: 2024-11-26
• Study First Posted: 2024-11-29
• Last Update Posted: 2024-11-29
• Study Start: 2024-12
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 132

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.

Read More

Exclusion Criteria

• Have a history of or have been diagnosed with Type 1 or Type 2 diabetes mellitus or prediabetes.
• Have hemoglobin A1c (HbA1c) ≥ 5.7% or 39 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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY4060874 (Part A Subcutaneous)	LY4060874	Single ascending dose of LY4060874 administered subcutaneously (SC).
LY4060874 (Part A Intravenous)	LY4060874	Single ascending dose of LY4060874 administered intravenously (IV).
LY4060874 (Part B)	LY4060874	Multiple ascending doses of LY4060874 administered SC.
LY4060874 (Part B Chinese)	LY4060874	Multiple ascending doses of LY4060874 administered SC in Chinese participants.
LY4060874 (Part C Japanese)	LY4060874	Multiple ascending doses of LY4060874 administered SC in Japanese participants.
Placebo (SC)	Placebo	Placebo administered SC in Part A, B, and C.
Placebo (IV)	Placebo	Placebo administered IV in Part A.

Primary Outcome Measures

Name	Time	Method
Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	Baseline up to 22 Weeks	Number of participants with one or more TEAEs and SAEs.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Fortrea, Inc.; 🇺🇸 Dallas, Texas, United States

Lilly Centre for Clinical Pharmacology; 🇸🇬 Singapore, Singapore