A Study of LY3867070 in Healthy Participants

A Single- and Multiple-Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of LY3867070 in Healthy Participants

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: LY3867070

• Study Type: Interventional
• Enrollment (Estimated): 196
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or; Phone Number: 1-317-615-4559; Email: LillyTrials@Lilly.com
• Study Contact Backup: Name: Physicians interested in becoming principal investigators please contact; Email: clinical_inquiry_hub@lilly.com

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • Recruiting
      • Anaheim Clinical Trials, LLC
      • Principal Investigator: Amina Haggag
      • Contact: Phone Number: 714-774-7777, ext. 1012
  • Texas
    • Dallas, Texas, United States, 75247
      • Recruiting
      • Fortrea Clinical Research Unit
      • Principal Investigator: Gene Voskuhl
      • Contact: Phone Number: 866-429-3700

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LY3867070 (Part A); Single-Ascending Dose of LY3867070 administered orally	Drug: LY3867070; Administered orally
Experimental: LY3867070 (Part B); Multiple-Ascending Doses of LY3867070 administered orally	Drug: LY3867070; Administered orally
Experimental: LY3867070 (Part C); Multiple Doses of LY3867070 administered orally	Drug: LY3867070; Administered orally
Placebo Comparator: Placebo (Parts A-C); Placebo administered orally	Drug: Placebo; Administered orally
Experimental: LY3867070 (Part D); Drug-Drug Interaction (DDI) administered orally	Drug: LY3867070; Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: 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 record dates

Study Major Dates

• Study Start (Actual): May 27, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: May 21, 2025
• First Submitted That Met QC Criteria: June 13, 2025
• First Posted (Actual): June 15, 2025

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: 18873; J5H-MC-KVAA (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No