LY3981314 given under the skin in healthy adults
A Single-Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of LY3981314 in Healthy Participants
This study will test whether LY3981314, given by subcutaneous injection, is safe and how the body processes it in healthy adults.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 76 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Eli Lilly and Company Industry-sponsored |
| Locations | 1 site (Anaheim, California) |
| Trial ID | NCT07005284 on ClinicalTrials.gov |
What this trial studies
This is a Phase 1, randomized, placebo-controlled safety and pharmacokinetic study of subcutaneous LY3981314 in healthy participants. The study includes screening, a main period of about 25 weeks, and an optional extension to about 49 weeks for qualifying participants. Participants will receive LY3981314 or placebo and undergo regular clinical exams, blood sampling, ECGs, and lab tests to monitor safety and drug levels. Part B includes ancestry-specific enrollment criteria for first-generation Japanese and defined Chinese descent participants.
Who should consider this trial
Good fit: Healthy adults with body weight 45–145 kg and BMI 18.5–35 kg/m², adequate venous access, required contraceptive status, and for Part B those meeting the study's first-generation Japanese or defined Chinese ancestry criteria are ideal candidates.
Not a fit: People with active health conditions, those outside the weight/BMI or contraceptive requirements, or those seeking direct therapeutic benefit should not expect clinical benefit from this Phase 1 study.
Why it matters
Potential benefit: If successful, the trial could show that LY3981314 is safe and well tolerated in humans and support further clinical testing for therapeutic use.
How similar studies have performed: Phase 1, placebo-controlled subcutaneous safety and pharmacokinetic studies are routine and often inform development decisions, but LY3981314 itself is investigational with no established therapeutic track record.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and 12-lead electrocardiogram (ECG) * Individuals assigned male at birth who agree to follow contraceptive requirements, or individuals assigned female at birth and not of childbearing potential * Have venous access sufficient to allow for blood sampling * Have a body weight within 45 to 145 kilograms (kg) and body mass index within the range of 18.5 to 35 kilogram per square meter (kg/m²) (inclusive) * For Part B: * Japanese participants must be first-generation Japanese, defined as the participant, the participant's biological parents, and all of the participant's biological grandparents being of exclusive Japanese descent and born in Japan * To qualify as Chinese for this study, all 4 of the participant's biological grandparents must be of exclusive Chinese descent and born in China Exclusion Criteria: * Have known allergies to LY3981314, related compounds, or any components of the formulation * Have a significant history of or current rheumatologic, cardiovascular, respiratory, renal, gastrointestinal, endocrine (such as Cushing syndrome, 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 received at least 1 live vaccine within 28 days of screening, or intend to do so during the study, or within 28 days after the study * Had any surgical procedure (except for minor surgery requiring local or no anesthesia and without any complications or sequelae) within 12 weeks prior to screening, or intend to do so during the study, or within 28 days after the study * Show evidence of active or latent tuberculosis (TB) * Have used, or intend to use, prescription or nonprescription medication within 14 days prior to dosing (or 5 half-lives - whichever is longer) * Have a diagnosis or history of malignant disease * Have a history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection that, in the opinion of the sponsor or investigator, poses an unacceptable risk to the participant * Have had any significant infections within 3 months prior to the screening visit or develop any of these infections before the randomization visit * Have used, or intend to use, prescription or nonprescription medication within 14 days prior to dosing (or 5 half-lives - whichever is longer) * Have participated in a clinical study involving an investigational product within the last 30 days of the final drug administration (or 5 half-lives, whichever is longer) * Have donated 500 milliliters (mL) of blood or more or participated in a clinical study that required a blood volume of at least 500 mL, within the past 3 months
Where this trial is running
Anaheim, California
- CenExel ACT — Anaheim, California, United States (Recruiting)
Study contacts
- Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- Email: LillyTrials@Lilly.com
- Phone: 1-317-615-4559
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.