LY3981314 for Healthy Subjects

Overseen By Physicians interested in becoming principal investigators please contact

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Eli Lilly and Company

Must not be taking: Prescription, Nonprescription

Disqualifiers: Rheumatologic, Cardiovascular, Respiratory, others

Compensation: Varies

Number of Visits: Unknown

Duration: 25 weeks

76 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the safety of LY3981314 (an experimental treatment) when administered under the skin and how the body processes it. It includes several groups, with some receiving the actual treatment and others a placebo (an inactive substance). Participants should be generally healthy and free of major health issues. Those with a history of allergies to the drug or recent surgeries should not participate. The study seeks to recruit healthy Japanese and Chinese individuals for certain parts. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any prescription or nonprescription medications at least 14 days before the study starts, or longer if the medication stays in your body for a longer time.

Is there any evidence suggesting that LY3981314 is likely to be safe for humans?

In a previous study, researchers examined the safety of LY3981314 when administered to healthy participants via subcutaneous injection. The study aimed to understand how the body processes the treatment and to assess its safety. As this trial is in an early phase, the primary focus is on ensuring safety and identifying any side effects.

Specific reports on the tolerance of LY3981314 or any serious adverse effects have not yet emerged. This phase primarily aims to identify potential safety issues. While detailed information is not yet available, the treatment continues to undergo safety testing. Although there is limited information on its effects in humans, any common serious problems would likely have been detected by now. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

LY3981314 is unique because it offers a new approach by being administered subcutaneously, potentially providing a more consistent delivery of medication directly into the bloodstream. Unlike current treatments that might involve oral administration, this subcutaneous method can lead to more predictable absorption and steady drug levels. Researchers are excited about LY3981314's potential to provide a more effective and possibly faster response due to this innovative delivery method.

What evidence suggests that LY3981314 could be effective for healthy subjects?

Research on LY3981314 remains in the early stages. This trial primarily tests LY3981314 to understand its safety and how the body processes it, rather than to demonstrate its effectiveness for any specific condition. Participants will receive LY3981314 as a subcutaneous injection, with some receiving single-ascending doses and others a single dose. Due to limited evidence on its efficacy, researchers focus on its behavior in the body. Future studies will likely explore its effectiveness for specific health issues. ^{1 2 3 5 6}

Who Is on the Research Team?

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)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This study is for healthy individuals who want to participate in medical research. Participants will be involved in the trial for about 25 weeks, with a possible extension up to 49 weeks if they qualify.

Inclusion Criteria

My weight is between 45 and 145 kg, and my BMI is between 18.5 and 35.

I agree to use contraception or am not able to become pregnant.

I can have blood drawn without difficulty.

Exclusion Criteria

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

I have been diagnosed with or have a history of cancer.

Have known allergies to LY3981314, related compounds, or any components of the formulation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive single-ascending doses of LY3981314 or placebo administered subcutaneously

25 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

24 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LY3981314

Trial Overview

The trial is testing LY3981314, which is given as a subcutaneous injection (under the skin). The focus is on assessing its safety and how it's processed by the body compared to a placebo.

How Is the Trial Designed?

Group I: LY3981314 Part B Experimental Treatment 1 Intervention

Single dose of LY3981314 administered SC

Group II: LY3981314 Part A Experimental Treatment 1 Intervention

Single-ascending doses of LY3981314 administered subcutaneously (SC)

Group III: Placebo Part B Placebo Group 1 Intervention

Placebo administered SC

Group IV: Placebo Part A Placebo Group 1 Intervention

Placebo administered SC

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Citations

1.

patlynk.com

patlynk.com/trial/NCT07005284

Safety and Pharmacokinetics of LY3981314 in Healthy ...

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

2.

trial.medpath.com

trial.medpath.com/clinical-trial/d51b12bc9bc89d28/nct07005284-ly3981314-safety-pharmacokinetics-healthy-participants

A Study of LY3981314 in Healthy Participants | MedPath

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 ...

3.

withpower.com

withpower.com/trial/phase-1-healthy-subjects-hs-5-2025-da3b7

LY3981314 for Healthy Subjects

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 ...

4.

ichgcp.net

ichgcp.net/clinical-trials-registry/NCT07005284

A Study of LY3981314 in Healthy Participants - ICH GCP

The main purpose of this study is to investigate the safety of LY3981314 when administered subcutaneously (SC) (under the skin), ...

5.

sigma.larvol.com

sigma.larvol.com/facility.php?FacilityId=23777464

Fortrea Clinical Research Unit Trials

NCT07005284: A Study of LY3981314 in Healthy Participants. Recruiting. 1 ; Doisy, Kathleen ; NCT05644353: A Bioequivalence Study of Mirikizumab (LY3074828) ...

6.

ctv.veeva.com

ctv.veeva.com/study/a-study-of-ly3981314-in-healthy-participants

A Study of LY3981314 in Healthy Participants

The main purpose of this study is to investigate the safety of LY3981314 when administered subcutaneously (SC) (under the skin), ...