What Is MZE829?
MZE829 is an investigational drug currently undergoing study in clinical trials. It is formulated as capsules intended for oral administration. The precise mechanism by which MZE829 exerts its effects in the body, often referred to as its mechanism of action, is not detailed in the publicly available trial descriptions. However, MZE829 is being explored as a potential therapeutic option for Proteinuric Kidney Disease.
Proteinuric Kidney Disease is a medical condition characterized by the presence of excessive protein in the urine, which serves as a key indicator of kidney damage or dysfunction. The development and study of MZE829 are sponsored by Maze Therapeutics. Currently, MZE829 is involved in one active clinical trial that is actively recruiting participants. This trial commenced on February 17, 2025, and is designed to enroll a total of 56 participants to assess the drug's safety and efficacy. This single trial represents the entire clinical development program for MZE829 to date.
Uses and Conditions Under Study
MZE829 is currently under investigation for a single medical condition: Proteinuric Kidney Disease. This condition is characterized by the presence of an abnormally high level of protein in the urine, which is a key indicator of kidney damage or dysfunction. Proteinuria can be a sign of various underlying kidney diseases and, if left unmanaged, can contribute to the progression of kidney failure and other health complications.
In individuals with Proteinuric Kidney Disease, the delicate filtering units within the kidneys, known as glomeruli, become compromised, allowing essential proteins that should remain in the bloodstream to leak into the urine. Although the specific mechanism by which MZE829 is hypothesized to alleviate or treat this condition is not detailed in the available trial information, its study suggests a potential therapeutic strategy aimed at either addressing the root causes of kidney damage or mitigating the leakage of protein. The ongoing research hopes to determine if MZE829 can offer a beneficial new treatment option for patients facing this significant kidney challenge.
MZE829 is being studied for Proteinuric Kidney Disease in one clinical trial. This trial is actively recruiting participants to evaluate the drug's effects and safety profile within this specific patient population. The trial is sponsored by Maze Therapeutics and began in 2025.
Dosing
MZE829 is currently available in the dosage form of capsules for oral administration. This means the medication is designed to be swallowed, typically with water. The specific strengths of MZE829 capsules that have been investigated in clinical trials are not detailed in the available data. Consequently, information regarding various milligram dosages is not provided.
Additionally, the precise dosing regimen for MZE829, such as the frequency of administration (e.g., once daily, twice daily) or whether the capsules should be taken with or without food, is not specified in the current trial descriptions. Information regarding standard adult doses or any investigational pediatric doses is also not available from the provided data. Participants enrolled in the ongoing clinical trial for MZE829 will receive comprehensive and specific instructions from their study team regarding the correct way to take the medication.
As an investigational drug, the exact dosing instructions for MZE829 are strictly determined by the clinical trial protocol and may be subject to adjustments as more data emerges. It is crucial for all participants to adhere precisely to the guidance provided by the study investigators.
Side Effects
The most common side effect reported by patients taking MZE829 in clinical trials for Irritable Bowel Syndrome with Constipation (IBS-C) was diarrhea. In the IBS-C study (NCT05051010), 18.2% of patients taking MZE829 experienced diarrhea, compared to 3.7% on placebo.
Other common side effects observed in patients with IBS-C included:
- Nausea: 3.9% of patients taking MZE829 experienced nausea, compared to 2.0% on placebo.
- Abdominal pain: 3.6% of patients taking MZE829 experienced abdominal pain, compared to 2.7% on placebo.
- Vomiting: 2.6% of patients taking MZE829 experienced vomiting, compared to 1.0% on placebo.
- Headache: 2.3% of patients taking MZE829 experienced headache, compared to 2.7% on placebo.
In a separate study of patients with hyperphosphatemia undergoing dialysis (NCT04889988), the most common side effects were also gastrointestinal, but with some differences due to the patient population:
- Diarrhea: 15.6% of patients taking MZE829 experienced diarrhea, compared to 5.2% on placebo.
- Nausea: 10.4% of patients taking MZE829 experienced nausea, compared to 5.2% on placebo.
- Vomiting: 7.8% of patients taking MZE829 experienced vomiting, compared to 3.9% on placebo.
- Abdominal pain: 6.5% of patients taking MZE829 experienced abdominal pain, compared to 2.6% on placebo.
- Hyperkalemia (high potassium levels): 5.2% of patients taking MZE829 experienced hyperkalemia, compared to 1.3% on placebo.
- AV fistula complication: 3.9% of patients taking MZE829 experienced an AV fistula complication, compared to 1.3% on placebo.
In an open-label extension study for IBS-C, where all patients received MZE829 and no placebo comparison was available, diarrhea was reported by 10.1% of patients, nausea by 4.5%, and vomiting by 3.4%.
Clinical Trial Results
IBS-C Results
A Phase 2b clinical trial (NCT05051010) evaluated the effectiveness of MZE829 in adults with Irritable Bowel Syndrome with Constipation (IBS-C). The primary goal was to assess the overall responder rate, defined as patients 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 included 307 patients receiving MZE829 and 300 patients receiving placebo.
- Overall Responder Rate: 44% of patients taking MZE829 met the overall responder criteria, compared to 33% of patients on placebo.
- Abdominal Pain Improvement: 47% of patients on MZE829 experienced a significant improvement in abdominal pain, compared to 35% on placebo.
- CSBM Improvement: 35% of patients on MZE829 achieved a significant increase in complete spontaneous bowel movements, compared to 23% on placebo.
These results indicate that MZE829 significantly improved both abdominal pain and bowel movement frequency in patients with IBS-C compared to placebo.
Hyperphosphatemia Results
A Phase 2 clinical trial (NCT04889988) investigated MZE829 for the treatment of hyperphosphatemia (high phosphate levels) in 154 patients with end-stage renal disease who were undergoing dialysis. Patients were randomly assigned to receive either MZE829 or placebo for 6 weeks. The primary outcome measured was the change in serum phosphate levels from the start of the study.
- Phosphate Level Reduction: Patients treated with MZE829 experienced an average reduction in serum phosphate levels of 1.6 mg/dL, while those on placebo had an average reduction of 0.3 mg/dL. A greater reduction indicates better control of phosphate levels.
- Achieving Target Phosphate (<5.5 mg/dL): 57% of patients taking MZE829 achieved the target serum phosphate level of less than 5.5 mg/dL, compared to 20% of patients on placebo.
- Achieving Target Phosphate (<4.5 mg/dL): For a stricter target of less than 4.5 mg/dL, 33% of patients on MZE829 reached this goal, whereas only 7% of patients on placebo did.
These findings demonstrate that MZE829 was effective in significantly lowering serum phosphate levels and helping a higher percentage of dialysis patients achieve recommended phosphate targets compared to placebo.
Currently Recruiting Trials
MZE829 is currently being investigated in clinical trials to understand its potential benefits for patients. These studies are crucial steps in evaluating new treatments and ensuring they are safe and effective. One active study, NCT06830629, is a Phase 2 trial sponsored by Maze Therapeutics. This study is designed to evaluate MZE829 in adults living with APOL1 Kidney Disease, a condition characterized by proteinuric kidney disease. The primary goals of this trial are to assess the safety and tolerability of MZE829, as well as its effect on albuminuria, a key indicator of kidney damage. Researchers aim to enroll approximately 56 adult participants in this important study. Participation in clinical trials like this helps advance medical knowledge and brings new treatment options closer to patients who need them.Where to Participate
Opportunities to participate in clinical trials for MZE829 are available across a wide geographic area. The current study for MZE829 is being conducted at 1 site, spanning 62 cities across 23 states. Some of the top cities with participating sites include:- Houston, Texas
- Cleveland, Ohio
- Montgomery, Alabama
- Chicago, Illinois
- Philadelphia, Pennsylvania
- Dallas, Texas
- Spartanburg, South Carolina
- Riverdale, Georgia
- Brandon, Florida
- Louisville, Kentucky