LY3867070 safety and how the body processes it in healthy adults

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

This will test whether LY3867070 is safe and how your body handles it in healthy adults.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 196 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Eli Lilly and Company (industry)
• Locations: 2 sites (Anaheim, California and 1 other locations)
• Trial ID: NCT07021547 on ClinicalTrials.gov

What this trial studies

This Phase 1, placebo-controlled study gives oral doses of LY3867070 to healthy volunteers to characterize tolerability and how the drug is processed. Participants receive LY3867070 or placebo and have regular blood tests to measure drug levels and biological effects. Safety monitoring includes tracking side effects and medical exams, and Part B may include skin biopsies while Part C enrolls Japanese and Chinese participants. The study is conducted at U.S. clinical research sites under sponsorship from Eli Lilly to inform dosing and safety for later patient trials.

Who should consider this trial

Good fit: Overtly healthy adults who pass medical screening, weigh at least 45 kg, have a BMI of 18–32 kg/m², and (for Part C) are Japanese or Chinese are the intended participants.

Not a fit: People with significant medical, psychiatric, endocrine (including thyroid) or allergic conditions, recent smokers, or those unwilling to undergo required procedures (such as skin biopsies in Part B) are excluded and unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the study could identify safe dosing and how LY3867070 behaves in the body, enabling future trials in patients who might benefit.

How similar studies have performed: Placebo-controlled Phase 1 safety and pharmacokinetic studies in healthy volunteers are a standard first step and have successfully guided dosing for many drugs, though LY3867070 itself is a novel compound.

Eligibility criteria

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

Where this trial is running

Anaheim, California and 1 other locations

• Anaheim Clinical Trials, LLC — Anaheim, California, United States (NOT_YET_RECRUITING)
• Fortrea Clinical Research Unit — Dallas, Texas, United States (RECRUITING)

Study contacts

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

Conditions: Healthy