LY3848575 for Healthy Subjects

Overseen By There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Eli Lilly and Company

Disqualifiers: Other clinical study participation

Compensation: Varies

Number of Visits: Unknown

Duration: Approximately 20 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests LY3848575, an experimental drug, to assess its safety and tolerability in healthy individuals. Researchers aim to understand how the body processes this treatment, examining how quickly it enters the bloodstream and its duration there. Participants receive either the treatment or a placebo (a substance with no active treatment) through injections under the skin or directly into the veins. The trial targets healthy individuals who haven't recently participated in another trial and meet specific weight and ancestry criteria. As a Phase 1 trial, it focuses on understanding how the treatment works in people, offering participants the unique opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, since the study is for healthy participants, it's possible that taking medications might affect eligibility.

Is there any evidence suggesting that LY3848575 is likely to be safe for humans?

Research has shown that LY3848575 has undergone testing in other studies to assess its safety and tolerability. In one study, participants received the treatment through an IV in single doses, and it was generally well-tolerated. Another study examined its use for nerve pain and found LY3848575 to be safe compared to a placebo.

The current trial is in the early stages (Phase 1), focusing on determining the treatment's safety for humans. This phase helps researchers understand how the treatment affects the body. Early-stage trials like this are crucial for assessing safety before progressing to larger studies.

Overall, early findings from these studies suggest LY3848575 has a good safety profile so far. However, as testing continues, more data is needed to confirm these results. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

LY3848575 stands out because it offers a fresh approach to treatment by coming in both subcutaneous (SC) and intravenous (IV) forms, giving more flexibility in how it's administered. Unlike many existing treatments, LY3848575 is designed to be delivered directly into the bloodstream or under the skin, potentially offering quicker and more targeted effects. Researchers are particularly excited about its unique mechanism of action, which could provide more efficient results compared to standard therapies that often rely on different, less direct methods. This versatility and novel action could mean better outcomes and new possibilities for patients.

What evidence suggests that LY3848575 could be effective?

Research shows that LY3848575 is a new drug being tested for safety and tolerability. Although detailed efficacy data is limited, similar drugs have shown promise in treating nerve pain. In this trial, participants will receive LY3848575 either subcutaneously or intravenously in separate treatment arms. The trial aims to understand how the body absorbs and processes the drug. While solid evidence for specific conditions is not yet available, this study will provide insights into how LY3848575 functions in the body. Early findings on similar drugs suggest potential benefits, but further research is needed. ^{1 2 3 4 5}

Who Is on the Research Team?

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This trial is for healthy adults who weigh at least 50 kg (110 lbs) for males, 40 kg (88 lbs) for females, and have a BMI of 18-30. Japanese participants must be first-generation with all parents and grandparents born in Japan. Participants can't join if they're in another study or were in one within the last 3 months.

Inclusion Criteria

I weigh at least 50kg if male, 40kg if female, and my BMI is between 18-30.

Participants who are overtly healthy as determined by medical evaluation

I am of first-generation Japanese descent, with all my parents and grandparents born in Japan.

Exclusion Criteria

Have participated, within the last 3 months, in a clinical study involving an IP.

Are currently enrolled in any other clinical study involving an investigational product (IP) or any other type of medical research judged not to be scientifically or medically compatible with this study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive single ascending or multiple doses of LY3848575 administered either intravenously or subcutaneously

Approximately 20 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LY3848575

Trial Overview The study tests LY3848575 given by IV or under the skin to see how safe it is and how the body handles it. It compares this new drug to a placebo over roughly five months, including screening time before starting.

How Is the Trial Designed?

Group I: LY3848575 SC Experimental Treatment 1 Intervention

Multiple doses of LY3848575 administered subcutaneously (SC).

Group II: LY3848575 IV Experimental Treatment 1 Intervention

Single ascending doses of LY3848575 administered intravenously (IV).

Group III: Placebo SC Placebo Group 1 Intervention

Placebo administered SC.

Group IV: Placebo IV Placebo Group 1 Intervention

Placebo administered IV.

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. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-1-2023-ff7dc

LY3848575 for Healthy Subjects · Info for Participants This trial is testing a new drug called LY3848575 to see if it is safe and well-tolerated. The study includes healthy non-Japanese and first-generation ...

2. synapse.patsnap.com synapse.patsnap.com/drug/b77f9142ea554bf8bb41a3a8c33572c9

LY-3848575 - Drug Targets, Indications, Patents A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Investigate Safety, Tolerability, and Pharmacokinetics With Single Intravenous Ascending Doses.

3. withpower.com withpower.com/trial/phase-2-neuralgia-9-2024-d64ae

LY3848575 for Neuropathic Pain The purpose of this study is to evaluate how safe and how well a treatment works compared to placebo for people with nerve pain that begins in their feet ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05727072

A Study of LY3848575 in Healthy Participants A phase of research to describe clinical trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the goal is to ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12064609/

Population Pharmacokinetics and Pharmacodynamics of ... Early phase clinical studies demonstrated fepixnebart has nonlinear pharmacokinetics in healthy subjects and patients with diabetic nephropathy.