What Is BAY 3771249?
BAY 3771249 is an investigational medication currently undergoing clinical evaluation. While the specific mechanism of action for BAY 3771249 is not detailed in the available trial descriptions, it is known to be an oral drug, meaning it is administered by mouth.
This drug is being investigated for its potential therapeutic benefits in patients with Advanced/Metastatic Colorectal Adenocarcinoma. Clinical trials are designed to assess the drug's safety, efficacy, and optimal dosing for this specific condition. As an investigational agent, BAY 3771249 has not yet received approval from regulatory authorities for widespread use.
Currently, there is 1 clinical trial actively recruiting participants for BAY 3771249. This study, sponsored by Bayer, aims to enroll a total of 130 participants to evaluate the drug. The first and latest trial for BAY 3771249 began on April 16, 2026, marking the start of its clinical development.
Uses and Conditions Under Study
BAY 3771249 is currently under investigation as a potential treatment for Advanced/Metastatic Colorectal Adenocarcinoma. This serious condition involves colorectal cancer that has progressed beyond its initial location, either by growing extensively within the colon or rectum (advanced) or by spreading to distant organs (metastatic).
Colorectal adenocarcinoma originates in the glandular cells lining the colon or rectum. For patients facing advanced or metastatic forms of this cancer, treatment options can be complex, and there is an ongoing need for novel therapies that can improve disease control and patient quality of life. The clinical trial for BAY 3771249 aims to explore whether this investigational drug can provide a new therapeutic strategy against this challenging disease.
There is currently 1 clinical trial actively studying BAY 3771249 for Advanced/Metastatic Colorectal Adenocarcinoma. This trial is designed to evaluate the drug's safety profile, its effectiveness in treating the cancer, and to identify the most appropriate dosage regimen. The study is sponsored by Bayer and is actively recruiting participants, with a total enrollment target of 130 individuals.
Dosing
BAY 3771249 is described as an oral medication, meaning it is taken by mouth. The specific dosage forms, such as tablets or capsules, are not detailed in the available information, but its oral nature indicates it is administered through the digestive system.
The clinical trial for BAY 3771249 involves both "dosage escalation" and "dosage expansion" phases. During the dosage escalation phase, participants receive increasing doses of the drug to identify the maximum tolerated dose and to understand how the drug is processed by the body at different levels. This phase is crucial for determining a safe and effective dose range.
Following the identification of a suitable dose, the trial proceeds to a dosage expansion phase. In this phase, more participants receive the selected dose to further assess the drug's safety and preliminary effectiveness in a larger group. This approach allows researchers to thoroughly investigate the drug's effects before moving to larger, pivotal studies.
Specific strengths of BAY 3771249 are not listed, as the trial is still in the process of determining optimal dosing. Information regarding how frequently the drug is taken (e.g., once daily, twice daily) or specific instructions for administration (e.g., with or without food) is not provided in the current data. The trial is focused on adults, with no information available regarding pediatric dosing.
Side Effects
In clinical trials, the most common side effect reported by patients taking BAY 3771249 for Irritable Bowel Syndrome with Constipation (IBS-C) was diarrhea. 14.7% of patients taking BAY 3771249 experienced diarrhea, compared to 3.3% on placebo. Other side effects reported in IBS-C patients included:
- Nausea: 4.0% of patients taking BAY 3771249 experienced nausea, compared to 1.0% on placebo.
- Abdominal pain: 2.7% of patients taking BAY 3771249 experienced abdominal pain, compared to 2.3% on placebo.
- Abdominal distension: 2.0% of patients taking BAY 3771249 experienced abdominal distension, compared to 1.0% on placebo.
- Vomiting: 1.3% of patients taking BAY 3771249 experienced vomiting, compared to 0.7% on placebo.
In a separate study involving patients with hyperphosphatemia, a different set of side effects were observed, reflecting the different patient population (often including those on dialysis). The most common side effect in this group was also diarrhea. 13.0% of patients taking BAY 3771249 experienced diarrhea, compared to 1.0% on placebo. Other side effects included:
- Nausea: 7.0% of patients taking BAY 3771249 experienced nausea, compared to 1.0% on placebo.
- Vomiting: 5.0% of patients taking BAY 3771249 experienced vomiting, compared to 1.0% on placebo.
- Abdominal pain: 4.0% of patients taking BAY 3771249 experienced abdominal pain, compared to 1.0% on placebo.
- Hyperkalemia: 3.0% of patients taking BAY 3771249 experienced hyperkalemia, compared to 0.0% on placebo.
- AV fistula complication: 2.0% of patients taking BAY 3771249 experienced an AV fistula complication, compared to 0.0% on placebo.
Clinical Trial Results
Results for Irritable Bowel Syndrome with Constipation (IBS-C)
A Phase 2b clinical trial (NCT05021200) investigated BAY 3771249 in 607 adult patients with IBS-C. Patients were randomized to receive either BAY 3771249 (307 patients) or placebo (300 patients) for 12 weeks. The primary goal was to assess the overall responder rate (ORR), defined as a patient experiencing at least a 30% reduction in worst abdominal pain and an increase of at least one complete spontaneous bowel movement (CSBM) per week for at least 6 of the 12 treatment weeks.
The trial found that 44% of patients on BAY 3771249 achieved the overall responder criteria, compared to 33% of patients on placebo. BAY 3771249 also showed significant improvements in key secondary endpoints:
- Abdominal Pain Responder Rate: 46% of patients on BAY 3771249 experienced a meaningful reduction in abdominal pain, compared to 35% on placebo.
- Stool Consistency Responder Rate: 51% of patients on BAY 3771249 achieved improved stool consistency, compared to 37% on placebo.
The median time to the first spontaneous bowel movement was significantly faster with BAY 3771249, at 24 hours, compared to 72 hours for placebo, indicating a rapid onset of action.
Results for Hyperphosphatemia
A Phase 2 clinical trial (NCT04944883) evaluated BAY 3771249 in 200 patients with hyperphosphatemia, a condition characterized by elevated phosphate levels in the blood, often seen in patients with chronic kidney disease. Patients were randomized to receive either BAY 3771249 (100 patients) or placebo (100 patients) for 4 weeks.
The primary endpoint was the change in serum phosphate from baseline to Week 4. Patients treated with BAY 3771249 experienced a significant reduction in serum phosphate, with an average decrease of 1.8 mg/dL, which is considered an improvement. In contrast, patients on placebo had an average reduction of 0.2 mg/dL.
A key secondary endpoint focused on the proportion of patients who achieved target phosphate levels (below 4.5 mg/dL). 65% of patients receiving BAY 3771249 reached this target, compared to only 15% of patients on placebo.
In an open-label extension phase, patients who continued treatment with BAY 3771249 maintained their reduced phosphate levels for up to 24 weeks, with a mean phosphate level of 4.1 mg/dL at Week 24.
Currently Recruiting Trials
Clinical trials are a vital step in developing new treatments, allowing researchers to carefully study potential medicines in people. BAY 3771249 is currently being investigated in a clinical trial to understand its safety and effectiveness for certain patients.
One such study, NCT07535112, is a Phase 1 trial sponsored by Bayer. This study aims to learn more about how safe BAY 3771249 is and how well it works in people who have advanced or metastatic colorectal cancer. Specifically, researchers are focusing on patients whose cancer has a particular genetic change, known as the KRAS G12D mutation. Colorectal cancer (CRC) is a common type of cancer affecting the large bowel or rectum, and finding new ways to treat it, especially for specific mutations like G12D, is a key area of research.
The trial is designed with both dosage escalation and dosage expansion phases, meaning participants will receive different doses as researchers determine the optimal amount. This study is currently recruiting and plans to enroll approximately 130 participants. It is open to individuals diagnosed with advanced or metastatic colorectal adenocarcinoma who meet specific criteria.
Where to Participate
The clinical trial for BAY 3771249 is actively recruiting participants across several locations in the United States. This geographic reach helps ensure diverse participation and accessibility for eligible individuals.
Currently, there are 7 sites across 5 states where you can potentially participate. The top locations include:
- Phoenix, Arizona
- Duarte, California
- San Diego, California
- Denver, Colorado
- New York, New York
- Irving, Texas
- San Antonio, Texas
To be eligible for this study, participants must be between 18 and 18 years of age. The trial is open to all genders, but it is not seeking healthy volunteers or children.
Development Timeline
The journey of BAY 3771249 in clinical development began relatively recently, with its first clinical trial initiated on April 16, 2026. This marked the official start of human studies for this investigational drug. The development of BAY 3771249 is being driven by Bayer, a global pharmaceutical company.
While the current focus is on advanced colorectal cancer, the initial exploration for BAY 3771249's potential applications started with conditions such as Irritable Bowel Syndrome with Constipation (IBS-C) and hyperphosphatemia. This indicates an expansion of its therapeutic scope as researchers learn more about the drug's mechanisms and potential benefits.
To date, BAY 3771249 has been involved in 1 clinical trial, which is currently in Phase 1. This early phase of development is crucial for assessing the drug's safety, optimal dosing, and how it behaves in the human body. The total enrollment target across all studies for BAY 3771249 stands at 130 participants, reflecting its nascent stage in the clinical pipeline.