A Study of LY3867070 in Healthy Participants

Phase 1

Recruiting

• Conditions: Healthy
• Interventions: Drug: LY3867070; Drug: Placebo

• Registration Number: NCT07021547
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-21
• Study Start: 2025-05-27
• Study First Submitted QC: 2025-06-13
• Last Update Submitted: 2025-06-13
• Study First Posted: 2025-06-15
• Last Update Posted: 2025-06-15
• Primary Completion: 2026-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 196

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 capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational medicinal product; or of interfering with the interpretation of data
• Have used, or intend to use, prescription or nonprescription medication (including dietary supplements, vitamins, herbal supplements such as St. John's wort, traditional Chinese medicine, or alternative medicines), or any medications known to be strong inhibitors and inducers of the genes CYP1A1, CYP1A2, CYP2B6, CYP3A4 and CYP2C19, within 14 days prior to dosing of any study intervention until end of study assessments are complete
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3867070 (Part A)	LY3867070	Single-Ascending Dose of LY3867070 administered orally
LY3867070 (Part B)	LY3867070	Multiple-Ascending Doses of LY3867070 administered orally
LY3867070 (Part C)	LY3867070	Multiple Doses of LY3867070 administered orally
Placebo (Parts A-C)	Placebo	Placebo administered orally
LY3867070 (Part D)	LY3867070	Drug-Drug Interaction (DDI) administered orally
LY3867070 (Optional Part E)	LY3867070	LY3867070 administered orally

Primary Outcome Measures

Name	Time	Method
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) Considered by the Investigator to be Related to Study Drug Administration	Baseline up to Approximately Week 7	A summary of TEAEs regardless of causality, will be reported in the Reported Adverse Events module
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	Baseline up to Approximately Week 7	A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module
Number of Participants with One or More Adverse Event(s) (AEs) Considered by the Investigator to be Related to Study Drug Administration	Baseline up to Approximately Week 7	A summary of AEs regardless of causality, will be reported in the Reported Adverse Events module

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3867070	Baseline up to Approximately Week 7	PK: AUC of LY3867070
PK: Maximum Concentration (Cmax) of LY3867070	Baseline up to Approximately Week 7	PK: Cmax of LY3867070
Part B Pharmacodynamic (PD): Change from Baseline in CYP1A1 Gene Expression	Baseline up to Approximately Week 6	PD: Change from Baseline in CYP1A1 Gene Expression

Trial Locations

Locations (2)

Anaheim Clinical Trials, LLC; 🇺🇸 Anaheim, California, United States

Fortrea Clinical Research Unit; 🇺🇸 Dallas, Texas, United States