A Study of LY3867070 in Healthy Participants

NCT07021547 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 18873J5H-MC-KVAA
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) Considered by the Investigator to be Related to Study Drug Administration

  A summary of TEAEs regardless of causality, will be reported in the Reported Adverse Events module

  Baseline up to Approximately Week 7

• Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

  A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module

  Baseline up to Approximately Week 7

• Number of Participants with One or More Adverse Event(s) (AEs) Considered by the Investigator to be Related to Study Drug Administration

  A summary of AEs regardless of causality, will be reported in the Reported Adverse Events module

  Baseline up to Approximately Week 7

Secondary Outcomes (3)

• Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3867070

  Baseline up to Approximately Week 7

• PK: Maximum Concentration (Cmax) of LY3867070

  Baseline up to Approximately Week 7

• Part B Pharmacodynamic (PD): Change from Baseline in Gene Expression

  Baseline up to Approximately Week 6

Study Arms (5)

LY3867070 (Part A)

EXPERIMENTAL

Single-Ascending Dose of LY3867070 administered orally

Drug: LY3867070

LY3867070 (Part B)

EXPERIMENTAL

Multiple-Ascending Doses of LY3867070 administered orally

Drug: LY3867070

LY3867070 (Part C)

EXPERIMENTAL

Multiple Doses of LY3867070 administered orally

Drug: LY3867070

Placebo (Parts A-C)

PLACEBO COMPARATOR

Placebo administered orally

Drug: Placebo

LY3867070 (Part D)

EXPERIMENTAL

Drug-Drug Interaction (DDI) administered orally

Drug: LY3867070

Interventions

LY3867070 DRUG

Administered orally

LY3867070 (Part A); LY3867070 (Part B); LY3867070 (Part C); LY3867070 (Part D)

Placebo DRUG

Administered orally

Placebo (Parts A-C)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (2)

Anaheim Clinical Trials, LLC

Anaheim, California, 92801, United States

NOT YET RECRUITING

Fortrea Clinical Research Unit

Dallas, Texas, 75247, United States

RECRUITING

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Central Study Contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

1-317-615-4559; LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Part D will be open-label
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parts A, B, and C are parallel. Part D is open-label fixed-sequence.

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: June 15, 2025
• Study Start: May 27, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)