60 Participants NeededMy employer runs this trial

LY4005130 for Hair Loss

Recruiting at 31 trial locations
Tq
Pi
Overseen ByPhysicians interested in becoming principal investigators please contact
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of a new treatment, LY4005130, for individuals with severe alopecia areata, a condition causing significant hair loss. Researchers aim to determine if this drug promotes hair regrowth and how well participants tolerate it compared to a placebo (a substance with no active drug). Participants will receive the treatment intravenously over approximately 48 weeks. Ideal candidates for the trial are those who have lost more than half of their scalp hair due to alopecia areata for at least six months, without significant regrowth. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

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

The trial does not specify if you need to stop taking your current medications, but you must agree not to use any treatments for alopecia areata during the study.

Is there any evidence suggesting that LY4005130 is likely to be safe for humans?

Research has shown that LY4005130 underwent safety testing in earlier studies. Initial results from a study with healthy volunteers examined tolerance levels and potential side effects of LY4005130. Although specific results from these studies aren't provided, the treatment's progression to a Phase 2 trial suggests it demonstrated some safety in earlier research. Phase 2 trials typically aim to confirm both the safety and effectiveness of a treatment, indicating that LY4005130 was likely well-tolerated in earlier phases. However, as with any study, participants should be aware of possible side effects and discuss any concerns with the study team.12345

Why do researchers think this study treatment might be promising for hair loss?

LY4005130 is unique because it is administered intravenously, which sets it apart from most hair loss treatments that are typically topical or oral. This delivery method could potentially allow the active ingredient to be more effectively absorbed, offering a new approach for those who haven’t seen results with traditional treatments like minoxidil or finasteride. Researchers are excited about LY4005130 because it may target the underlying causes of hair loss more directly, possibly leading to more significant hair regrowth.

What evidence suggests that LY4005130 might be an effective treatment for severe alopecia areata?

Research has shown that LY4005130, which participants in this trial may receive, might help treat severe alopecia areata, a condition causing significant hair loss. Early results suggest that LY4005130 affects certain processes involved in hair growth, potentially leading to regrowth in areas of loss. Although detailed information from human studies remains limited, early tests in similar conditions have shown promising results in promoting hair regrowth. These findings suggest that LY4005130 could be effective for individuals with severe hair loss due to alopecia areata.12346

Who Is on the Research Team?

C1

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 adults with severe alopecia areata (patchy hair loss covering 50–90% of the scalp) that has lasted at least 6 months but less than 4 years, and who haven't had significant hair regrowth or used other treatments recently. People with certain health problems or other types of hair loss can't join.

Inclusion Criteria

No significant spontaneous hair regrowth in the investigator's opinion for at least 6 months
Agree not to use any AA treatments during the study
I have severe hair loss covering 50% to 90% of my scalp from Alopecia Areata.
See 1 more

Exclusion Criteria

My hair loss is mostly diffuse, with widespread shedding.
I do not have any serious or unstable health conditions affecting major organs.
I currently have another type of hair loss.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LY4005130 or placebo intravenously to evaluate efficacy and safety

24 weeks
Regular visits for IV administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

20-22 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • LY4005130

Trial Overview

The study compares an IV drug called LY4005130 to a placebo (inactive treatment) in people with severe alopecia areata. Participants are randomly assigned to receive either the study drug or placebo over about 48 weeks.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: LY4005130Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Citations

A Study of LY4005130 in Adult Participants With Severe ...

The purpose of this study is to evaluate how well LY4005130 works in participants with severe alopecia areata (hair loss) when compared with placebo, ...

A Study of LY4005130 in Adult Participants With Alopecia Areata

Participants must not: Have a primarily “diffuse” type of alopecia areata. This means that hair loss is widespread all over the scalp and not found in patches.

A Study of LY4005130 in Adult Participants With Severe ...

The purpose of this study is to evaluate how well LY4005130 works in participants with severe alopecia areata (hair loss) when compared with placebo, ...

A Study of LY4005130 in Adult Participants With Alopecia Areata

A Study of LY4005130 in Adult Participants With Alopecia Areata ... This means that hair loss is widespread all over the scalp and not found in patches.

LY4005130 for Hair Loss

The purpose of this study is to evaluate how well LY4005130 works in participants with severe alopecia areata (hair loss) when compared with placebo, ...

A Phase 2, Randomized, Multicenter, Double-Blind, Placebo ...

The purpose of this study is to evaluate how well LY4005130 works in participants with severe alopecia areata (hair loss) when compared with ...