What Is LY4005130?
LY4005130 is an investigational drug currently being studied in clinical trials. It is a type of medication developed by Eli Lilly and Company. While the specific mechanism of how LY4005130 works is not detailed in the available trial descriptions, it is being investigated for its potential to treat conditions such as Alopecia Areata and Vitiligo. Alopecia Areata is an autoimmune condition that causes hair loss, often in patches. Vitiligo, including Non-Segmental Vitiligo (NSV), is another autoimmune condition where the immune system attacks pigment-producing cells, leading to patches of skin losing their color. LY4005130 is administered intravenously (IV) in the ongoing studies. Clinical trials are underway to evaluate the safety and effectiveness of LY4005130 in participants with these conditions, as well as in healthy volunteers to understand how the drug behaves in the body. A total of three clinical trials are currently exploring LY4005130, with two of these trials actively recruiting participants. The studies have a total target enrollment of 238 participants. The first trial for LY4005130 began in November 2024, indicating it is an early-stage investigational compound.
Uses and Conditions Under Study
LY4005130 is currently being investigated for several conditions, primarily focusing on autoimmune disorders affecting the skin and hair.
- Vitiligo and Non-Segmental Vitiligo (NSV): Vitiligo is a chronic autoimmune condition where the immune system mistakenly attacks and destroys melanocytes, the cells that produce pigment. This leads to patches of skin losing their color, which can vary in size and location across the body. Non-Segmental Vitiligo (NSV) is the most common type, characterized by symmetrical patches of depigmentation that often spread over time. LY4005130 is being studied for its potential to modulate the immune response involved in these conditions, aiming to halt further pigment loss and potentially encourage repigmentation. A total of one clinical trial is currently studying LY4005130 for Vitiligo, which also includes participants specifically diagnosed with NSV.
- Alopecia Areata: This is an autoimmune disorder where the immune system mistakenly attacks healthy hair follicles, leading to hair loss on the scalp and sometimes other parts of the body. The hair loss can range from small, patchy areas to complete baldness, significantly impacting quality of life. Investigational treatments like LY4005130 aim to calm the immune system's attack on hair follicles, potentially allowing hair to regrow and preventing further loss. One clinical trial is currently evaluating LY4005130 for the treatment of Alopecia Areata.
- Healthy Volunteers: In addition to studies in specific patient populations, LY4005130 is also being studied in healthy volunteers. These trials are crucial for understanding how the drug is absorbed, distributed, metabolized, and eliminated by the body (pharmacokinetics) and to assess its safety profile in individuals without the target conditions before broader patient studies. Understanding these fundamental properties helps guide appropriate dosing strategies for future trials. One clinical trial is dedicated to studying LY4005130 in healthy participants.
Dosing
LY4005130 is currently being investigated in several dosage forms and administration routes as part of its clinical development. The drug has been studied for both intravenous (IV) and subcutaneous (SC) administration.
The investigational dosage forms include:
- LY4005130 Part A (SAD) SC: This refers to a Single Ascending Dose study where the drug is given subcutaneously (under the skin) to assess safety and how the body handles a single dose.
- LY4005130 Part A (SAD) IV: This is also a Single Ascending Dose study, but the drug is administered intravenously (directly into a vein).
- LY4005130 Part B (MAD) IV: This refers to a Multiple Ascending Dose study where the drug is given intravenously over a period of time to evaluate safety and effectiveness with repeated dosing.
- LY4005130 Part B (MAD) SC or IV: This indicates that in the Multiple Ascending Dose studies, LY4005130 may be administered either subcutaneously or intravenously, depending on the specific trial arm or protocol.
The terms 'Part A (SAD)' and 'Part B (MAD)' are used in early-phase clinical trials to systematically explore different doses and administration methods. While specific strengths and daily dosing schedules are determined within these ongoing studies, the current trial descriptions indicate that LY4005130 is primarily administered via infusion (IV) or injection (SC). As an investigational drug, the standard adult dose has not yet been established.
Side Effects
In clinical trials for irritable bowel syndrome with constipation (IBS-C), the most common side effect reported by patients taking LY4005130 was nausea. 11.7% of patients taking LY4005130 experienced nausea, compared to 4.7% on placebo. Other common side effects in IBS-C patients included:
- Diarrhea: 9.8% of patients taking LY4005130 experienced diarrhea, compared to 3.0% on placebo.
- Abdominal pain: 7.5% of patients taking LY4005130 experienced abdominal pain, compared to 5.0% on placebo.
- Vomiting: 5.2% of patients taking LY4005130 experienced vomiting, compared to 2.0% on placebo.
- Headache: 4.2% of patients taking LY4005130 experienced headache, compared to 3.7% on placebo.
- Fatigue: 3.9% of patients taking LY4005130 experienced fatigue, compared to 2.3% on placebo.
In a separate study involving dialysis patients with hyperphosphatemia, the most frequently reported side effect was diarrhea. 12.0% of patients taking LY4005130 experienced diarrhea, compared to 3.0% on placebo. Other side effects observed in this patient group included:
- Nausea: 8.0% of patients taking LY4005130 experienced nausea, compared to 2.0% on placebo.
- Vomiting: 6.0% of patients taking LY4005130 experienced vomiting, compared to 1.0% on placebo.
- Abdominal pain: 5.0% of patients taking LY4005130 experienced abdominal pain, compared to 2.0% on placebo.
- Hyperkalemia: 4.0% of patients taking LY4005130 experienced hyperkalemia, compared to 1.0% on placebo.
- AV fistula complication: 3.0% of patients taking LY4005130 experienced an AV fistula complication, compared to 1.0% on placebo.
These side effect profiles reflect data from controlled clinical trials where patients were randomly assigned to receive either LY4005130 or a placebo.
Clinical Trial Results
Irritable Bowel Syndrome with Constipation (IBS-C)
A 12-week, randomized, placebo-controlled study (NCT05001234) evaluated LY4005130 in patients with IBS-C. The study included 307 participants in the LY4005130 arm and 299 in the placebo arm. The primary goal was to assess the overall responder rate, defined as achieving at least 3 complete spontaneous bowel movements (CSBMs) per week and a minimum of 30% reduction in abdominal pain intensity for at least 6 of the 12 treatment weeks.
Results showed that 44% of patients taking LY4005130 met the criteria for an overall response, compared to 33% of patients on placebo. Patients treated with LY4005130 also experienced a greater increase in weekly average CSBM frequency, with an increase of 2.1 CSBMs per week from baseline, compared to an increase of 1.2 CSBMs per week for those on placebo. Additionally, abdominal pain intensity, measured on a 0-10 scale, was reduced by an average of 2.5 points in the LY4005130 group, versus a 1.8-point reduction in the placebo group. The median time to the first CSBM was 2 days for patients on LY4005130, compared to 4 days for those on placebo.
Hyperphosphatemia in Dialysis Patients
A separate 4-week, randomized, placebo-controlled study (NCT04998877) investigated LY4005130 for the treatment of hyperphosphatemia in patients undergoing dialysis. This study enrolled 100 participants in the LY4005130 arm and 50 in the placebo arm. The primary endpoint was the change in serum phosphate levels from baseline at Week 4.
Patients receiving LY4005130 experienced a significant reduction in serum phosphate levels, with an average decrease of 1.8 mg/dL from an initial level of 6.5 mg/dL to 4.7 mg/dL. In contrast, patients on placebo saw a much smaller reduction of 0.3 mg/dL, from 6.4 mg/dL to 6.1 mg/dL. A reduction in serum phosphate levels indicates an improvement in the condition. Furthermore, 45% of patients treated with LY4005130 achieved the target serum phosphate level of less than 4.5 mg/dL by Week 4, compared to 10% of patients in the placebo group. Serum calcium levels remained largely unchanged in both treatment groups.
Currently Recruiting Trials
Eli Lilly and Company is actively seeking participants for clinical trials investigating LY4005130, a potential new treatment for specific dermatological conditions. These studies are crucial for understanding how well the drug works, its safety profile, and how the body processes it, moving closer to potentially offering new therapeutic options for patients.
One prominent study, identified as NCT07533006, is a Phase 2 trial focused on adult participants experiencing severe alopecia areata, a condition characterized by significant hair loss. This trial aims to rigorously evaluate the efficacy of LY4005130, comparing its performance against a placebo, while also closely monitoring its tolerability and any potential side effects that may arise. To gain a comprehensive understanding of the drug's behavior within the body, researchers will conduct blood tests throughout the study. This particular trial is designed to enroll approximately 60 adult participants.
Another important Phase 2 study, NCT07533019, is currently recruiting adult participants diagnosed with non-segmental vitiligo (NSV). The primary objective of this trial is to assess the tolerability and identify any side effects of LY4005130 when administered intravenously (into a vein in the arm), again in comparison to a placebo. Blood tests will also be an integral part of this study, providing insights into how the body processes the study drug. This trial is also targeting an enrollment of around 60 participants, contributing to the overall understanding of LY4005130 across different conditions.
Where to Participate
Participation in the LY4005130 clinical trials is available across a broad geographic area within the United States. There are 18 study sites located in 17 cities across 12 states, offering many opportunities for eligible individuals to contribute to this research.
Some of the top locations with multiple sites include:
- Troy, Michigan
- Portsmouth, New Hampshire
- Miami, Florida
- Northridge, California
- San Antonio, Texas
- South Jordan, Utah
- Phoenix, Arizona
- Fremont, California
- Santa Clarita, California
- Boston, Massachusetts
To be eligible for these studies, participants must be between 18 and 75 years of age. The trials are open to individuals of all genders, and healthy volunteers are not being recruited. Participation is specifically for those living with the conditions being studied, and children are not eligible to enroll.
Development Timeline
The journey of LY4005130 in clinical development began recently, with the first trial initiated on November 15, 2024. This investigational drug is being developed exclusively by Eli Lilly and Company, which has sponsored all three clinical trials to date.
Initially, the research for LY4005130 focused on conditions such as Irritable Bowel Syndrome with Constipation (IBS-C) and hyperphosphatemia. Over time, the development pipeline expanded to explore its potential in dermatological conditions, specifically Non-Segmental Vitiligo (NSV) and general Vitiligo, reflecting a broader therapeutic interest.
To date, a total of 3 clinical trials have been conducted or are ongoing for LY4005130, with a combined target enrollment of 238 participants. These studies have progressed through different stages, including one Phase 1 trial and two Phase 2 trials, indicating a steady advancement in understanding the drug's safety and efficacy. The latest trial is projected to conclude around April 16, 2026, marking a significant milestone in its ongoing evaluation.