A Study of LY3981314 in Healthy Participants

Phase 1

Not yet recruiting

• Conditions: Healthy
• Interventions: Drug: LY3981314; Drug: Placebo

• Registration Number: NCT07005284
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The main purpose of this study is to investigate the safety of LY3981314 when administered subcutaneously (SC) (under the skin), and how it's processed in the body.

The study will last approximately 25 weeks, excluding a screening period with an optional extension to approximately 49 weeks for qualifying participants.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study Start: 2025-06
• Study First Submitted: 2025-06-03
• Study First Submitted QC: 2025-06-03
• Last Update Submitted: 2025-06-03
• Study First Posted: 2025-06-05
• Last Update Posted: 2025-06-05
• Primary Completion: 2027-02
• Study Completion: 2027-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 76

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3981314 Part A	LY3981314	Single-ascending doses of LY3981314 administered subcutaneously (SC)
LY3981314 Part B	LY3981314	Single dose of LY3981314 administered SC
Placebo Part A	Placebo	Placebo administered SC
Placebo Part B	Placebo	Placebo administered SC

Primary Outcome Measures

Name	Time	Method
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	Baseline up to Approximately Week 25	A summary of TEAEs and SAEs regardless of causality, will be reported in the Reported Adverse Events module

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3981314	Baseline Up to Approximately Week 25	PK: AUC of LY3981314
PK: Maximum Concentration (Cmax) of LY3981314	Baseline up to Approximately Week 25	PK: Cmax of LY3981314

Trial Locations

Locations (1)

CenExel ACT; 🇺🇸 Anaheim, California, United States