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Safety and Pharmacokinetics of LY3981314 in Healthy Participants

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What is being tested

LY3981314

+ Placebo
Drug
Who is being recruted

Healthy

From 18 to 65 Years
+19 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Basic Science Study

Placebo-Controlled
Phase 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) or
Last updated: September 25, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: June 9, 2025Actual 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 
Principal SponsorEli Lilly and Company
Study ContactTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Last updated: September 25, 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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 65 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Healthy
Criteria
7 inclusion criteria required to participate
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)

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12 exclusion criteria prevent from participating
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

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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

A summary of TEAEs and SAEs regardless of causality, will be reported in the Reported Adverse Events module
Secondary Objectives

PK: AUC of LY3981314

PK: Cmax of LY3981314

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 ACTAnaheim, United StatesSee the location
Recruiting
One Study Center