Recruiting

Safety and Pharmacokinetics of LY3981314 in Healthy Participants

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What is being tested

LY3981314

+ Placebo

Drug
Who is being recruted

From 18 to 65 Years
See all eligibility criteria
How is the trial designed

Basic Science Study

Placebo-ControlledPhase 1
Interventional
Study Start: June 2025
See protocol details

Summary

Principal SponsorEli Lilly and Company
Study ContactTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) orMore contacts
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: June 9, 2025

Actual date on which the first participant was enrolled.

This study is focused on evaluating the safety of a new drug named LY3981314 when given to healthy individuals. The drug is administered through an injection under the skin. Researchers are interested in understanding how the drug is processed in the body, which includes studying how it is absorbed, distributed, and eventually removed from the body. This research is crucial as it helps determine whether LY3981314 is safe enough to be used in future studies involving patients who may benefit from this medication. Participants in this study will receive single doses of the drug, and their health will be monitored over approximately 25 weeks, with the possibility of an extension to 49 weeks. This involves regular check-ups and tests to observe how the body reacts to the drug and ensure there are no adverse effects. Although there are no specified primary outcomes mentioned, the study's focus is on safety and understanding how the drug behaves in the human body. The information gathered will be valuable for guiding further research and development of LY3981314.

Official TitleA Single-Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of LY3981314 in Healthy Participants 
NCT07005284
Principal SponsorEli Lilly and Company
Study ContactTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) orMore contacts
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

76 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Single-ascending doses of LY3981314 administered subcutaneously (SC)

Group II

Experimental
Single dose of LY3981314 administered SC

Group III

Placebo
Placebo administered SC

Group IV

Placebo
Placebo administered SC

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

CenExel ACT

Anaheim, United StatesSee the location
Recruiting
One Study Center