LY4088044 for Healthy Participants

Recruiting at 5 trial locations

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: Drugs of abuse

Disqualifiers: Pregnancy, Hemoglobinopathy, Low GFR, others

Compensation: Varies

Number of Visits: Unknown

104 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess the tolerance of a new drug, LY4088044, in healthy individuals and to identify any side effects. The study will administer the drug either under the skin or directly into a vein and will measure its movement and duration in the body. Participants will receive either the drug or a placebo (a substance with no active drug) in different study phases. This trial suits individuals in good health who do not smoke heavily and have a moderate alcohol intake. As a Phase 1 trial, this research focuses on understanding the treatment's effects in people, offering participants the opportunity to be among the first to receive this new drug.

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

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should not regularly use drugs of abuse or have positive drug screenings that don't match their medication history.

Is there any evidence suggesting that LY4088044 is likely to be safe for humans?

Research shows that LY4088044 is under study to assess its safety and tolerability. This drug can be administered either under the skin or directly into a vein. The studies aim to understand how the body processes the drug and identify potential side effects.

Since LY4088044 is in the early testing stages, specific data from past studies is not yet available. Researchers are closely monitoring for any side effects or issues as they test different doses.

Such studies are crucial to ensure LY4088044's safety before advancing to more comprehensive research. Participants in these studies help researchers learn about the drug's safety and tolerability. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about LY4088044 because it introduces a new approach to treatment by offering both single-ascending and multiple-ascending doses, delivered either intravenously or subcutaneously. This flexibility in administration could lead to more personalized treatment options. Unlike many standard treatments that often rely on a single mode of action, LY4088044's varied dosing strategies might enhance its effectiveness and adaptability in clinical settings. Additionally, the innovative dosing method could potentially shorten the time it takes to see results, making it a promising option for patients and healthcare providers alike.

What evidence suggests that LY4088044 could be effective?

Research is investigating the safety of LY4088044 and how the body processes it. In this trial, LY4088044 is administered either as an injection under the skin or directly into a vein, with some participants receiving a placebo for comparison. Early studies with healthy individuals focus on assessing its safety and potential side effects. Specific information about its effectiveness for any particular condition is not yet available, which is typical for new drugs at this stage. The current goal is to ensure its safety before exploring its potential benefits for specific health issues. ^{1 2 3 6 7}

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 trial is for healthy individuals who want to participate in a study testing LY4088044. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and have no conflicting medical conditions.

Inclusion Criteria

I am generally healthy based on recent medical exams and tests.

Have a body mass index (BMI) within the range 18.5 to 30 kilogram per square meter (kg/m²)

Exclusion Criteria

Smoke more than 10 cigarettes per day or the equivalent including electronic cigarettes AND are unable to abide by investigative site smoking restrictions

Have a 12-lead electrocardiogram (ECG) abnormality

My hemoglobin levels are low or I have an iron deficiency or a blood disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Single-ascending dose (SAD) of LY4088044 or placebo administered intravenously (IV)

Up to 92 weeks

Treatment Part B

Single-ascending dose (SAD) of LY4088044 or placebo administered subcutaneously (SC)

Up to 92 weeks

Treatment Part C

Multiple-ascending doses (MAD) of LY4088044 or placebo administered intravenously (IV)

Up to 92 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Approximately 27 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LY4088044

Trial Overview The trial is assessing the tolerability of LY4088044 when given subcutaneously or intravenously to healthy subjects. It will also measure how much of the drug enters the bloodstream and its elimination rate over approximately 92 weeks.

How Is the Trial Designed?

Group I: LY4088044 (Part C) Experimental Treatment 1 Intervention

Multiple-ascending doses (MAD) of LY4088044 administered IV

Group II: LY4088044 (Part B) Experimental Treatment 1 Intervention

SAD of LY4088044 administered subcutaneously (SC)

Group III: LY4088044 (Part A) Experimental Treatment 1 Intervention

Single-ascending dose (SAD) of LY4088044 administered intravenously (IV)

Group IV: Placebo (Part A) Placebo Group 1 Intervention

Administered IV

Group V: Placebo (Part B) Placebo Group 1 Intervention

Administered SC

Group VI: Placebo (Part C) Placebo Group 1 Intervention

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. clinicaltrials.gov clinicaltrials.gov/study/NCT07090785

A Study of LY4088044 in Healthy Participants A type of intervention model describing a clinical trial in which groups of participants receive two or more interventions in a specific order. For example, two ...

2. theglobeandmail.com theglobeandmail.com/investing/markets/stocks/LLY-N/pressreleases/33819359/eli-lillys-new-study-on-ly4088044-a-potential-game-changer-in-drug-safety-evaluation/

Eli Lilly's New Study on LY4088044: A Potential Game ... The study aims to assess the safety and tolerability of LY4088044, a drug administered either subcutaneously or intravenously, in healthy ...

3. tipranks.com tipranks.com/news/company-announcements/eli-lillys-new-study-on-ly4088044-what-investors-need-to-know

Eli Lilly's New Study on LY4088044: What Investors Need ... The study aims to evaluate the safety and side effects of LY4088044 in healthy individuals, providing insights into its pharmacokinetics and ...

4. policylab.us policylab.us/clinical-trials/l/utah/condition/healthy

Healthy Paid Clinical Trials in Utah - Policy Lab The purpose of this study is to evaluate how well LY4088044 is tolerated and what side effects may occur in healthy participants. The study drug will be ...

5. sigma.larvol.com sigma.larvol.com/facility.php?e1=926907&e2=&FacilityId=926907&tab=FacilityOTT&sr=now&er=1+month&ipwnd=on&rlink=,FacilityId=926907,tab=trials,itype=0,1&rflag=1&page=1

ICON Early Phase Services Trials NCT07090785: A Study of LY4088044 in Healthy Participants. Recruiting. 1 ; YHAA, NCT07152002: A Study of LY4064912 in Healthy Participants and With Overweight or ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06847698

Study Details | NCT06847698 | Single Ascending Dose ... All SAD cohorts will be dosed according to a sentinel dosing design to ensure safety. Initially, 2 subjects will be dosed; 1 subject will be dosed with AVR-48 ...

7. unitytrials.org unitytrials.org/trials/detail/NCT07090785-a-study-of-ly4088044-in-healthy-participants

A Study of LY4088044 in Healthy Participants - Unity Trials The purpose of this study is to evaluate how well LY4088044 is tolerated and what side effects may occur in healthy participants.