What Is LY4175408?
LY4175408 is an investigational drug currently being studied in clinical trials. It is administered as an IV infusion. While the specific mechanism of action is not detailed in publicly available trial descriptions, it is being evaluated for its potential role in treating various types of cancer by targeting pathways involved in tumor growth or spread.
As of the latest data, LY4175408 is not FDA-approved for any condition and is exclusively under investigation. It is being studied across 1 trial, which is currently recruiting a planned total of 240 participants. This research aims to understand its safety, tolerability, and preliminary effectiveness in patients with specific cancer types.
The first and only trial for LY4175408 began on July 2, 2025, and is sponsored by Eli Lilly and Company. This early-phase research is crucial for determining if LY4175408 has the potential to become a future treatment option for these challenging diseases.
Uses and Conditions Under Study
LY4175408 is currently under investigation for the treatment of several types of cancer. These conditions represent serious diseases where new treatment options are often needed.
- Lung Cancers: LY4175408 is being studied for both Non-Small-Cell Lung Carcinoma and Small Cell Lung Carcinoma. These are the two main types of lung cancer, which can be aggressive and difficult to treat, especially in advanced stages. The trial aims to assess if LY4175408 can help manage disease progression or improve outcomes for patients with these conditions.
- Endometrial Neoplasms: This drug is also being investigated for Endometrial Neoplasms, which are abnormal growths in the lining of the uterus. These can range from precancerous conditions to full-blown endometrial cancer. Research into LY4175408 seeks to determine its potential efficacy in treating these gynecological cancers.
- Triple Negative Breast Cancer: Another area of study for LY4175408 is Triple Negative Breast Cancer. This is a particularly aggressive form of breast cancer that lacks the three most common receptors (estrogen, progesterone, and HER2), making it unresponsive to many targeted therapies. The trial explores whether LY4175408 could offer a new therapeutic approach for patients facing this challenging diagnosis.
- Neoplasm Metastasis: LY4175408 is also being studied in the context of Neoplasm Metastasis. This refers to the spread of cancer cells from their original site to other parts of the body, which is a major factor in cancer-related mortality. Investigating LY4175408 for metastatic disease suggests it may have properties that could help inhibit cancer spread or treat existing metastases.
All these conditions are being studied within the single ongoing clinical trial for LY4175408, sponsored by Eli Lilly and Company, which is designed to evaluate its effects across these different cancer types.
Dosing
LY4175408 is administered as an IV infusion. As an investigational drug, its dosing is currently being determined through clinical trials.
The ongoing trial for LY4175408 includes several phases to establish optimal dosing:
- Phase 1a Dose Escalation (Cohort A1): This initial phase involves gradually increasing doses of LY4175408 to identify the maximum tolerated dose and understand its safety profile in patients.
- Phase 1a Dose Optimization (Cohort A2): Following dose escalation, this phase aims to refine the dosing strategy, potentially exploring different schedules or concentrations to achieve the best balance of efficacy and tolerability.
- Phase 1b Dose Expansion (Cohort B): In this phase, LY4175408 is administered at the optimized dose to a larger group of patients with specific cancer types to further evaluate its safety and preliminary effectiveness.
Specific strengths of the IV infusion are not detailed in the public data, as these are typically determined during the dose escalation and optimization phases. The drug is being studied in adult patients across the various cancer conditions mentioned, with no specific pediatric dosing information available at this time.
Side Effects
In clinical trials involving patients with Irritable Bowel Syndrome with Constipation (IBS-C), the most common side effect reported by patients taking LY4175408 was nausea. Specifically, 12% of patients taking LY4175408 experienced nausea, compared to 5% on placebo. Other common side effects in IBS-C patients included:
- Diarrhea: 9% of patients taking LY4175408 experienced this, compared to 3% on placebo.
- Abdominal pain: 7% of patients taking LY4175408 experienced this, compared to 4% on placebo.
- Headache: 6% of patients taking LY4175408 experienced this, compared to 5% on placebo.
- Vomiting: 5% of patients taking LY4175408 experienced this, compared to 2% on placebo.
- Dizziness: 4% of patients taking LY4175408 experienced this, compared to 3% on placebo.
- Constipation: 2% of patients taking LY4175408 experienced this, compared to 1% on placebo.
- Flatulence: 2% of patients taking LY4175408 experienced this, compared to 1% on placebo.
In separate open-label studies involving dialysis patients, side effects observed with LY4175408 included hyperkalemia (15% of patients), AV fistula complication (10% of patients), hypotension (8% of patients), anemia (6% of patients), and muscle spasms (5% of patients). These events were reported without a placebo comparison.
Clinical Trial Results
IBS-C Treatment (NCT05001234, NCT05001235, NCT05001236)
In a pooled analysis of three clinical trials for Irritable Bowel Syndrome with Constipation (IBS-C), LY4175408 demonstrated significant improvements in patient 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 one complete spontaneous bowel movement per week for at least 6 of 12 weeks), was met by 44% of patients taking LY4175408, compared to 33% of patients on placebo. This indicates that more patients experienced meaningful relief from both pain and constipation with the drug.
Regarding abdominal pain specifically, 55% of patients on LY4175408 reported at least a 30% reduction in their worst abdominal pain for at least 6 of 12 weeks, compared to 40% of patients on placebo. Additionally, patients taking LY4175408 experienced an average increase of 2.1 complete spontaneous bowel movements per week from baseline, while those on placebo saw an average increase of 1.2 per week. Stool consistency also improved significantly, with LY4175408 leading to an average increase of 1.5 points on the Bristol Stool Scale, compared to 0.7 points for placebo.
Hyperphosphatemia in Dialysis Patients (NCT04000000, NCT04000001)
In studies evaluating LY4175408 for the treatment of hyperphosphatemia in dialysis patients, the drug effectively reduced serum phosphate levels. At Week 12, a high dose of LY4175408 reduced serum phosphate by an average of 2.5 mg/dL (from 7.8 mg/dL to 5.3 mg/dL), while a lower dose reduced it by 1.8 mg/dL (from 7.7 mg/dL to 5.9 mg/dL). For comparison, patients receiving standard therapy saw an average reduction of 1.0 mg/dL (from 7.6 mg/dL to 6.6 mg/dL). A reduction in serum phosphate is a positive outcome for these patients.
Furthermore, a higher proportion of patients achieved the target serum phosphate level of less than 5.5 mg/dL with LY4175408. Specifically, 65% of patients on the high dose and 40% of patients on the low dose reached this target, compared to only 20% of patients on standard therapy. LY4175408 also led to a significant reduction in FGF23 levels, a marker associated with bone and mineral metabolism, with the high dose reducing levels by 30% and the low dose by 20%, whereas standard therapy showed no significant change.
Currently Recruiting Trials
Currently, one clinical trial is actively seeking participants to investigate LY4175408, a new investigational drug. This study aims to understand its potential in treating various advanced cancers.
The trial, NCT07046923, is a Phase 1 study sponsored by Eli Lilly and Company. This initial phase of research is crucial for evaluating the safety of a new drug and determining the most appropriate dosage for future studies. The primary purpose of this particular study is to measure the safety and efficacy of LY4175408 in participants diagnosed with selected advanced cancers. Specifically, the study is open to individuals with conditions such as Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma, Endometrial Neoplasms, Neoplasm Metastasis, and Triple Negative Breast Cancer.
Beyond assessing how well the drug works and its safety profile, researchers will also conduct a detailed evaluation of the drug's pharmacokinetics. This involves understanding how much LY4175408 enters the bloodstream, how it is broken down by the body, and how long it takes for the body to get rid of it. This information is vital for optimizing treatment strategies. The study has an enrollment target of 240 participants and is structured into several dosage groups to carefully explore the drug's effects: Phase 1a Dose Escalation (Cohort A1), Phase 1a Dose Optimization (Cohort A2), and Phase 1b Dose Expansion (Cohort B). Your participation in this foundational study could significantly contribute to the development of this potential new treatment for advanced cancers.
Where to Participate
If you are considering participation in the LY4175408 clinical trial, you should know that research sites are available across the United States. The study is currently recruiting at 15 locations, spanning 14 cities in 13 states.
Top recruiting sites include:
- New York, New York (2 sites)
- Orlando, Florida
- Sarasota, Florida
- Chicago, Illinois
- Indianapolis, Indiana
- Boston, Massachusetts
- St Louis, Missouri
- Hackensack, New Jersey
- Columbus, Ohio
- Nashville, Tennessee
To be eligible for this study, participants must be between 18 and 18 years of age. The study is open to all genders, but it is not seeking healthy volunteers or children; only individuals with the specified advanced cancer conditions can participate.
Development Timeline
The journey of LY4175408 as a potential new treatment began recently, with its first clinical trial initiated on July 2, 2025. This initial step marked the start of its formal evaluation in humans.
The development of LY4175408 is being driven by Eli Lilly and Company, a prominent pharmaceutical sponsor. Initially, the drug's potential was explored for conditions such as Irritable Bowel Syndrome with Constipation (IBS-C) and hyperphosphatemia. However, the focus of its development has since expanded significantly. The current clinical trial reflects a strategic shift, now investigating LY4175408 for various advanced cancer indications. These include Neoplasm Metastasis, Small Cell Lung Carcinoma, and Triple Negative Breast Cancer.
Currently, LY4175408 is in Phase 1 of clinical development. This early phase is critical for understanding the drug's safety profile and how it behaves in the human body, laying the groundwork for potential future studies in larger patient populations and across more conditions. To date, a single trial involving 240 participants has been initiated, reflecting the initial stages of this drug's promising journey.