A Study of LY3867070 in Healthy Participants

Lilly

Status and phase: Enrolling; Phase 1

Conditions: Healthy

Treatments: Drug: LY3867070; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07021547

J5H-MC-KVAA (Other Identifier)

18873

Details and patient eligibility

About

The purpose of this study is to evaluate how well LY3867070 is tolerated and what side effects may occur in healthy participants. The study drug will be administered orally. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body.

Enrollment: 196 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Are overtly healthy as determined by medical evaluation
• Part C of the study includes only Japanese and Chinese participants
• Have a body weight greater than or equal to 45 kilogram (kg) and also body mass index 18 to 32 kilogram per square meter (kg/m²) inclusive

Exclusion criteria

• Have a history or presence of multiple or severe allergies, anaphylactic reaction to prescription or nonprescription drugs, or history of significant atopy
• Have a significant history or current thyroid disease
• Have a significant history of or current psychiatric disorders, rheumatologic, cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (such as Cushing syndrome and hyperaldosteronism), hematological, or neurological disorders
• Are smokers (including electronic cigarettes) within 6 months prior to screening and unwilling to refrain from smoking for the duration of the study.
• Unwilling to undergo skin biopsies (for Part B only)
• Are unwilling to have body hair cut or shaved in cases where hair, in the investigator's opinion, could interfere with noninvasive skin patch

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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196 participants in 6 patient groups, including a placebo group

LY3867070 (Part A)

Experimental group

Description:

Single-Ascending Dose of LY3867070 administered orally

Treatment:

Drug: LY3867070

LY3867070 (Part B)

Experimental group

Description:

Multiple-Ascending Doses of LY3867070 administered orally

Treatment:

Drug: LY3867070

LY3867070 (Part C)

Experimental group

Description:

Multiple Doses of LY3867070 administered orally

Treatment:

Drug: LY3867070

Placebo (Parts A-C)

Placebo Comparator group

Description:

Placebo administered orally

Treatment:

Drug: Placebo

LY3867070 (Part D)

Experimental group

Description:

Drug-Drug Interaction (DDI) administered orally

Treatment:

Drug: LY3867070

LY3867070 (Optional Part E)

Experimental group

Description:

LY3867070 administered orally

Treatment:

Drug: LY3867070