A Study of LY4060874 in Healthy Participants

Lilly

Status and phase: Enrolling; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Placebo; Drug: LY4060874

Study type: Interventional

Funder types: Industry

Identifiers

NCT06709820

J5X-MC-YJAA (Other Identifier)

27300

Details and patient eligibility

About

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.

Enrollment: 132 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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132 participants in 7 patient groups, including a placebo group

LY4060874 (Part A Subcutaneous)

Experimental group

Description:

Single ascending dose of LY4060874 administered subcutaneously (SC).

Treatment:

Drug: LY4060874

Drug: LY4060874

LY4060874 (Part A Intravenous)

Experimental group

Description:

Single ascending dose of LY4060874 administered intravenously (IV).

Treatment:

Drug: LY4060874

Drug: LY4060874

LY4060874 (Part B)

Experimental group

Description:

Multiple ascending doses of LY4060874 administered SC.

Treatment:

Drug: LY4060874

Drug: LY4060874

LY4060874 (Part B Chinese)

Experimental group

Description:

Multiple ascending doses of LY4060874 administered SC in Chinese participants.

Treatment:

Drug: LY4060874

Drug: LY4060874

LY4060874 (Part C Japanese)

Experimental group

Description:

Multiple ascending doses of LY4060874 administered SC in Japanese participants.

Treatment:

Drug: LY4060874

Drug: LY4060874

Placebo (SC)

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Drug: Placebo

Placebo (IV)

Placebo Comparator group

Description:

Placebo administered IV in Part A.

Treatment:

Drug: Placebo

Drug: Placebo