NCT07046559 A Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY4066708 in Healthy Participants
| NCT ID | NCT07046559 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Eli Lilly and Company |
| Condition | Healthy |
| Study Type | INTERVENTIONAL |
| Enrollment | 104 participants |
| Start Date | 2025-05-13 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 104 participants in total. It began in 2025-05-13 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The main purpose of this study is to explore the safety and any side effects of LY4066708 in healthy participants. The study will also measure how much LY4066708 gets into the bloodstream and the central nervous system and how long it takes the body to remove it. The study will last up to 24 weeks for each participant.
Eligibility Criteria
Inclusion Criteria: * Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring. * Japanese Participants Only: To qualify as a participant of first-generation Japanese origin, the participant, the participant's biological parents, and all the participant's biological grandparents must be of exclusive Japanese descent and born in Japan. * Chinese Participants Only: To qualify as Chinese for the purpose of this study, all 4 of the participants' biological grandparents must be of exclusive Chinese descent and born in China, Hong Kong, Macau, or Taiwan. * Have a body mass index (BMI) at the time of screening within the range 18.5 to 30 kilogram per meter squared (kg/m²) (inclusive). * Participants assigned female at birth (AFAB) not of childbearing potential and participants assigned male at birth (AMAB) willing to practice effective contraception throughout the study may participate. * Willingness to undergo study procedures which may include repeated lumbar punctures Exclusion Criteria: * Are individuals of childbearing potential (IOCBP). Notwithstanding their IOCBP status, participants AFAB are excluded if they are breastfeeding. * A history of additional risk factors for Torsades de Pointes (for example, heart failure, hypokalemia, family history of Long QT Syndrome). * The use of concomitant medications that prolong the QT/QTc interval. * Have known allergies to LY4066708 or any components of the formulation, or history of allergic reactions to any transferrin receptor (TfR) antibodies. * Have participated, within the 3 months of screening, in a clinical trial involving a study intervention (other than the study intervention used in this study). If the previous investigational product has a long half-life (t½), 3 months or 5 half-lives (whichever is longer) should have passed. * Are persons who have previously completed or withdrawn from this study and have previously received the study intervention. This exclusion criterion does not apply to subjects who are allowed to rescreen prior to randomization. * Have a 12-lead electrocardiogram (ECG) abnormality at screening that, in the opinion of the investigator, increases the risks associated with participating in the study, or may confound ECG data analysis. * Show evidence of hepatitis C and/or positive hepatitis C antibody. * Current infection with hepatitis B virus (HBV) or evidence of past infection with HBV, that is, positive for Hepatitis B surface antigen (HBsAg) or Hepatitis B core total antibody (anti-HBc). * A marked baseline prolongation of time from the start of the Q wave to the end of the T wave/ corrected QT interval (QT/QTc) interval (for example, repeated demonstration of a corrected time from the start of the Q wave to the end of the T wave interval - Fridericia formula (QTcF) interval greater than 450 ms).
Contact & Investigator
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
✉ LillyTrials@Lilly.com📞 1-317-615-4559
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)
STUDY DIRECTOR
Eli Lilly and Company
Frequently Asked Questions
Who can join the NCT07046559 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Healthy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07046559 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07046559 currently recruiting?
Yes, NCT07046559 is actively recruiting participants. Contact the research team at LillyTrials@Lilly.com for enrollment information.
Where is the NCT07046559 trial being conducted?
This trial is being conducted at Holbeck, Leeds, United Kingdom.
Who is sponsoring the NCT07046559 clinical trial?
NCT07046559 is sponsored by Eli Lilly and Company. The principal investigator is 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) at Eli Lilly and Company. The trial plans to enroll 104 participants.