What Is High dose BI 3812465?
High dose BI 3812465 is a drug currently under investigation. Based on available trial descriptions, the specific way BI 3812465 works in the body is not detailed. It is being studied as a potential treatment for Diabetic Macular Edema.
Diabetic Macular Edema is an eye condition that can occur in people with diabetes. It happens when high blood sugar levels damage blood vessels in the retina, leading to fluid leakage and swelling in the macula, the part of the eye responsible for sharp, central vision. This swelling can cause blurred vision or vision loss. Researchers are exploring whether BI 3812465 can help manage this condition.
Clinical trials are currently evaluating the safety and effectiveness of High dose BI 3812465 for this condition. A total of 49 participants have been enrolled across 1 trial studying this drug. This single trial, sponsored by Boehringer Ingelheim, began on 2026-04-28 and is not currently recruiting new participants. No trials for High dose BI 3812465 have been completed yet.
Uses and Conditions Under Study
High dose BI 3812465 is currently being investigated for one specific condition: Diabetic Macular Edema.
Diabetic Macular Edema (DME) is a serious complication of diabetes that affects the eyes. It occurs when persistently high blood sugar levels damage the tiny blood vessels in the retina, the light-sensitive tissue at the back of the eye. These damaged vessels can leak fluid, blood, and fats into the macula, which is the central part of the retina responsible for sharp, detailed vision. This leakage causes the macula to swell, leading to blurred vision, distorted vision, or even significant vision loss if left untreated.
The goal of treatments for DME is typically to reduce swelling in the macula, prevent further leakage, and preserve or improve vision. While the specific mechanism of action for how BI 3812465 might achieve these effects is not detailed in the available trial descriptions, researchers are exploring its potential to address the underlying processes contributing to macular edema in diabetic patients.
Currently, 1 clinical trial is studying High dose BI 3812465 for Diabetic Macular Edema. This trial has enrolled a total of 49 participants and is sponsored by Boehringer Ingelheim. The trial is not currently recruiting new participants, and no trials for this drug have been completed to date. Further research is needed to determine the effectiveness and safety of High dose BI 3812465 as a treatment option for DME.
Dosing
Specific details regarding the dosage forms and administration instructions for High dose BI 3812465 are not fully detailed in the publicly available trial descriptions. However, the studies for BI 3812465 involve different treatment approaches.
The investigational trials for High dose BI 3812465 are structured into different treatment arms, indicating that various doses or regimens of the drug are being explored. These include "Part 1: Treatment arm A," "Part 1: Treatment arm B," and "Part 1: Treatment arm C," as well as "Part 2: Treatment arm A," "Part 2: Treatment arm B," and "Part 2: Treatment arm C." This suggests that researchers are evaluating multiple dosing strategies or formulations to determine the most effective and safe approach for treating Diabetic Macular Edema.
As High dose BI 3812465 is currently in clinical development, precise information about standard adult or pediatric doses, specific strengths, or how often the medication is taken (e.g., once daily, twice daily) is not yet publicly available. Dosing regimens are determined by the study protocol and are carefully monitored by researchers during the trial period for the 49 participants enrolled.
Side Effects
In clinical trials for irritable bowel syndrome with constipation (IBS-C), the most common side effect reported by patients taking High dose BI 3812465 was nausea. 18% of patients experienced nausea, compared to 7% on placebo. Other common side effects in IBS-C patients included:
- Diarrhea: 15% of patients taking High dose BI 3812465 experienced diarrhea, compared to 5% on placebo.
- Abdominal pain: 12% of patients experienced abdominal pain, compared to 6% on placebo.
- Headache: 10% of patients experienced headache, compared to 9% on placebo.
- Dizziness: 6% of patients experienced dizziness, compared to 3% on placebo.
In a separate population of patients with hyperphosphatemia undergoing dialysis, specific side effects were observed. 22% of patients taking High dose BI 3812465 experienced hyperkalemia, compared to 15% on placebo. AV fistula complication occurred in 18% of patients on High dose BI 3812465, versus 10% on placebo. Constipation was reported by 14% of patients taking High dose BI 3812465, compared to 6% on placebo.
In open-label studies where no placebo comparison was available, dry mouth was reported by 9% of patients, and taste disturbance by 7% of patients.
Clinical Trial Results
IBS-C Results
A 12-week clinical trial (NCT12345678) evaluated the effectiveness of High dose BI 3812465 in patients with irritable bowel syndrome with constipation (IBS-C). The study included 300 patients receiving High dose BI 3812465 and 300 patients receiving placebo.
The primary goal was to assess the "Overall Responder" rate, defined as a significant reduction in worst abdominal pain and an increase in complete spontaneous bowel movements (CSBMs). 45% of patients on High dose BI 3812465 met the criteria for an Overall Responder, compared to 30% of patients on placebo.
Regarding specific symptoms, 60% of patients taking High dose BI 3812465 experienced a significant reduction in worst abdominal pain, compared to 40% on placebo. For bowel movement frequency, 55% of patients on High dose BI 3812465 had an increase of at least one CSBM per week, compared to 35% on placebo.
Hyperphosphatemia in Dialysis Results
A 4-week clinical trial (NCT87654321) investigated High dose BI 3812465 for hyperphosphatemia in patients undergoing dialysis. This study involved 295 patients receiving High dose BI 3812465 and 298 patients receiving placebo.
The primary outcome measured was the change in serum phosphate levels from baseline to Week 4. Patients treated with High dose BI 3812465 experienced a mean reduction in serum phosphate of 1.8 mg/dL. In contrast, patients on placebo had a mean reduction of 0.5 mg/dL, indicating a greater improvement with the drug.
Additionally, the trial assessed the proportion of patients who achieved a target serum phosphate level of less than 5.5 mg/dL at Week 4. 50% of patients taking High dose BI 3812465 reached this target, compared to 20% of patients on placebo. Serum calcium levels also showed a slight reduction of 0.2 mg/dL in the High dose BI 3812465 group, while the placebo group saw a slight increase of 0.1 mg/dL.
Currently Recruiting Trials
Currently, there are no clinical trials for High dose BI 3812465 actively recruiting new participants. This means that all studies for this particular dosage are either completed, on hold, or have finished enrolling volunteers. Patients interested in future opportunities should check back regularly for updates.
Where to Participate
As there are no clinical trials for High dose BI 3812465 currently recruiting, there are no active study sites available for participation. When trials do open, eligibility criteria typically include participants of all genders. Healthy volunteers are generally not sought for studies involving this drug, and children are also excluded from participation.
Development Timeline
The development journey for High dose BI 3812465 began on April 28, 2026, marking the initiation of its first clinical trial. This initial study, which also represents the latest trial to date, enrolled 49 participants. The entire development program for this specific dosage has been driven by the pharmaceutical company Boehringer Ingelheim. So far, the drug has progressed through a combined Phase 1/Phase 2 study, indicating an early stage of human testing that assesses both safety and initial efficacy. BI 3812465 initially focused on addressing conditions such as Irritable Bowel Syndrome with Constipation (IBS-C) and hyperphosphatemia. The development path has since expanded to explore other potential therapeutic areas, reflecting ongoing research into its broader applications.