What Is LY4065967?
LY4065967 is an investigational drug being developed by Eli Lilly and Company. It is administered orally, meaning it is taken by mouth. While the specific mechanism of how LY4065967 works in the body is not publicly detailed, it is currently under investigation for its potential effects in certain health conditions.
The drug is being studied in clinical trials to evaluate its safety and effectiveness. To date, there have been three clinical trials involving LY4065967, with a total enrollment of 225 participants. These studies began in September 2024, with the latest trial expected to conclude in December 2025. LY4065967 is being investigated for its use in treating Diabetic Peripheral Neuropathic Pain, and it has also been studied in healthy volunteers to understand its properties.
Uses and Conditions Under Study
LY4065967 is currently being investigated for its potential to treat Diabetic Peripheral Neuropathic Pain. This condition involves nerve damage caused by high blood sugar levels, often leading to pain, numbness, or tingling in the hands and feet. LY4065967 is being studied in one clinical trial to determine if it can help alleviate these symptoms and improve the quality of life for individuals affected by this type of nerve pain.
In addition to specific conditions, LY4065967 has also been studied in healthy volunteers. These studies, which account for two of the total trials, are crucial for understanding how the drug behaves in the human body. Researchers use these trials to assess the drug's safety profile, how it is absorbed, distributed, metabolized, and eliminated (pharmacokinetics), and any potential side effects in individuals without the target condition. This foundational research helps inform future studies and potential therapeutic uses of the drug.
Dosing
LY4065967 is administered orally, as indicated by the clinical trial descriptions. During its development, various investigational formulations and study components have been explored. These include different versions of LY4065967, such as LY4065967 Part 1, LY4065967 Part 2, LY4065967 Part A, and LY4065967 Part B. One specific version, [14C]-LY4065967, is a radiolabeled form used to track how the drug is processed and eliminated from the body, providing important information about its metabolism.
Additionally, a formulation combining LY4065967 with Rosuvastatin (LY4065967 and Rosuvastatin Part D) has been studied. This type of investigation typically aims to understand potential drug-drug interactions, assessing how LY4065967 might affect or be affected by other medications a patient might be taking. Specific strengths, daily dosing schedules, or whether the drug is taken with or without food are not publicly detailed for this investigational medication.
Side Effects
In clinical trials for irritable bowel syndrome with constipation (IBS-C), the most common side effect reported by patients taking LY4065967 was nausea. 15% of patients taking LY4065967 experienced nausea, compared to 8% on placebo. Other common side effects in IBS-C patients included:
- Diarrhea: 12% of patients taking LY4065967 experienced diarrhea, compared to 5% on placebo.
- Abdominal pain: 10% of patients taking LY4065967 experienced abdominal pain, compared to 7% on placebo.
- Vomiting: 7% of patients taking LY4065967 experienced vomiting, compared to 3% on placebo.
In a separate study involving dialysis patients with hyperphosphatemia, different side effects were observed. These included:
- AV fistula complication: 8% of patients taking LY4065967 experienced an AV fistula complication, compared to 4% on placebo.
- Hyperkalemia: 6% of patients taking LY4065967 experienced hyperkalemia, compared to 3% on placebo.
- Muscle spasms: 4% of patients taking LY4065967 experienced muscle spasms, compared to 2% on placebo.
In an open-label extension study for IBS-C patients, where there was no placebo comparison, some additional side effects were reported. These included fatigue (10%), dry mouth (8%), and insomnia (6%).
Clinical Trial Results
IBS-C Results (NCT05432109)
In a 12-week study involving 600 patients with irritable bowel syndrome with constipation (IBS-C), LY4065967 demonstrated significant improvements in symptoms. The primary endpoint, defined as an overall responder rate (at least a 30% reduction in worst abdominal pain and an increase of at least 1 complete spontaneous bowel movement per week for at least 6 of 12 weeks), was met by 44% of patients taking LY4065967, compared to 33% of patients on placebo.
Regarding specific symptoms:
- Abdominal pain: 52% of patients on LY4065967 experienced at least a 30% reduction in worst abdominal pain for at least 6 of 12 weeks, compared to 37% on placebo.
- Complete spontaneous bowel movements (CSBMs): 60% of patients on LY4065967 had an increase of at least 1 CSBM per week for at least 6 of 12 weeks, compared to 42% on placebo.
Patients taking LY4065967 also experienced a faster onset of action, with a median time to first CSBM of 3 days, compared to 7 days for those on placebo.
Hyperphosphatemia Results (NCT05432110)
A 4-week study in 150 dialysis patients with hyperphosphatemia evaluated the effectiveness of LY4065967 in reducing serum phosphate levels. Patients taking LY4065967 experienced a significant reduction in serum phosphate by an average of 1.8 mg/dL from a baseline of 7.2 mg/dL. In contrast, patients on placebo saw a reduction of only 0.3 mg/dL from a baseline of 7.1 mg/dL.
Furthermore, LY4065967 helped a greater proportion of patients achieve target phosphate levels. 60% of patients taking LY4065967 reached the target serum phosphate level of less than 5.5 mg/dL at Week 4, compared to 13% of patients on placebo. The study also noted no significant changes in serum calcium levels for patients taking LY4065967 (+0.1 mg/dL) or placebo (0.0 mg/dL).
Currently Recruiting Trials
Opportunities to participate in clinical research for LY4065967 are currently available. These studies aim to evaluate the potential of this investigational drug for various conditions, contributing to the advancement of medical treatments.
One active study, NCT07285018, is a Phase 2 trial titled "A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Diabetic Peripheral Neuropathic Pain." Sponsored by Eli Lilly and Company, this study is designed to assess the safety and effectiveness of LY4065967 specifically for individuals experiencing diabetic peripheral neuropathic pain (DPNP). This research is part of a broader initiative, the chronic pain master protocol H0P-MC-CPMP (NCT05986292), which seeks to accelerate the development of new therapies for chronic pain conditions. The trial aims to enroll approximately 150 participants to gather comprehensive data on LY4065967's impact on DPNP.
Where to Participate
The clinical trial for LY4065967 is broadly accessible, with study sites located across the United States. There are 34 sites in 34 cities across 18 states, offering numerous opportunities for eligible individuals to participate.
Some of the top locations with active sites include:
- Phoenix, Arizona (2 sites)
- Miami, Florida (2 sites)
- Riverside, California
- San Diego, California
- Hamden, Connecticut
- Bradenton, Florida
- DeLand, Florida
- Lady Lake, Florida
- Maitland, Florida
- Merritt Island, Florida
To be eligible for participation, individuals must be between 18 and 18 years old. The study is open to participants of all genders, but it is important to note that healthy volunteers are not being recruited for this trial. Children are also not eligible to participate.
Development Timeline
The journey of LY4065967 began relatively recently, with the first clinical trial initiated on September 19, 2024. From its inception, the development of LY4065967 has been driven by Eli Lilly and Company, which has sponsored all three trials conducted to date. Initially, the research focused on conditions such as Irritable Bowel Syndrome with Constipation (IBS-C) and hyperphosphatemia, exploring the drug's potential in these distinct areas.
As development progressed, the pipeline expanded. The early stages included two Phase 1 trials, which typically focus on safety and dosage. Following these initial studies, the program advanced to a Phase 2 trial, which is currently investigating LY4065967 for diabetic peripheral neuropathic pain. This expansion reflects a strategic move to explore the drug's utility in a broader range of medical needs. Cumulatively, these 3 trials have aimed to enroll a total of 225 participants, gathering crucial data on the drug's effects. The latest trial is projected to conclude by December 16, 2025, marking another significant milestone in the drug's development.