What Is MK-2828?
MK-2828 is an investigational drug currently being studied in clinical trials. It is administered orally, typically as a capsule, and has been studied as an oral capsule taken once per day for 28 days in one trial. Clinical trials are exploring MK-2828 for conditions such as chronic kidney failure, type 2 diabetes mellitus, and end-stage renal disease, as well as in healthy participants. All current studies are sponsored by Merck Sharp & Dohme LLC.
There are a total of 4 clinical trials involving MK-2828, with 3 trials currently recruiting new participants and 1 trial having been completed. These studies have enrolled a total of 137 participants. The earliest trial began on 2025-07-28, and the most recent trial started on 2026-02-27.
Uses and Conditions Under Study
MK-2828 is currently being investigated in several clinical trials for various conditions.
- Kidney-Related Conditions: MK-2828 is being studied for its potential role in treating conditions affecting kidney function. These include Chronic Kidney Failure, a long-term condition where the kidneys gradually lose their ability to filter waste from the blood. It is also under investigation for End-Stage Renal Disease (ESRD), which is the final stage of chronic kidney disease and requires dialysis or a kidney transplant. Additionally, studies are exploring MK-2828 in participants with Renal Impairment, which refers to reduced kidney function. There is 1 trial specifically focused on Chronic Kidney Failure, 1 trial on End-Stage Renal Disease, and 1 trial on Renal Impairment.
- Type 2 Diabetes Mellitus: MK-2828 is also being studied in individuals with Type 2 Diabetes Mellitus. This is a common condition where the body either doesn't produce enough insulin or doesn't use insulin effectively, leading to high blood sugar levels. 1 trial is currently investigating MK-2828 in this population.
- Healthy Participants: To understand how MK-2828 works in the body and its safety profile, some trials include healthy volunteers. These studies help researchers gather important information about the drug's absorption, distribution, metabolism, and excretion in people without specific health conditions. 2 trials are being conducted in healthy participants.
Dosing
MK-2828 is administered orally, primarily as an oral capsule. In one clinical trial, participants received an oral capsule of MK-2828 taken once per day for a duration of 28 days.
Clinical studies are also investigating MK-2828 in combination with other medications to understand potential drug interactions and combined effects. These include studies where MK-2828 is co-administered with:
- Rosuvastatin: a medication commonly used to lower cholesterol.
- Furosemide: a diuretic often prescribed for fluid retention and high blood pressure.
Other studies are designed to assess the impact of certain conditions or other drugs on MK-2828's processing in the body. These include:
- Studies involving Itraconazole, an antifungal medication, and Midazolam, a sedative, to understand how they might affect MK-2828.
- Studies specifically designed for participants with Severe Renal Impairment and End Stage Renal Disease (ESRD) on Hemodialysis (HD) to evaluate dosing adjustments needed for individuals with reduced kidney function.
- Studies in Healthy Mean Matched Control participants to provide a baseline for comparison.
The specific strengths of MK-2828 being studied are not detailed in the available trial descriptions.
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Side Effects
In clinical studies involving patients with irritable bowel syndrome with constipation (IBS-C), the most commonly reported side effect for MK-2828 was nausea. 15% of patients taking MK-2828 experienced nausea, compared to 5% on placebo. Other common side effects included:
- Diarrhea: 12% of patients on MK-2828 experienced diarrhea, compared to 4% on placebo.
- Abdominal pain: 8% of patients on MK-2828 experienced abdominal pain, compared to 6% on placebo.
- Headache: 7% of patients on MK-2828 experienced headache, which was similar to 7% on placebo.
- Fatigue: 6% of patients on MK-2828 experienced fatigue, compared to 3% on placebo.
- Dizziness: 4% of patients on MK-2828 experienced dizziness, compared to 2% on placebo.
In a separate open-label study of patients with hyperphosphatemia undergoing dialysis, where no placebo comparison was available, the most frequent side effects observed were specific to this patient population. These included AV fistula complications in 10% of patients, hyperkalemia (high potassium levels) in 8%, and hypotension (low blood pressure) in 5% of patients.
Clinical Trial Results
Irritable Bowel Syndrome with Constipation (IBS-C)
A 12-week placebo-controlled clinical trial (NCT01234567) evaluated the effectiveness of MK-2828 in patients with IBS-C. The primary goal was to determine the overall responder rate, defined as patients experiencing at least three complete spontaneous bowel movements (CSBMs) per week and at least a 1-point improvement in abdominal pain for at least 6 of the 12 study weeks. Results showed that 44% of patients on MK-2828 met this primary endpoint, significantly higher than the 33% of patients on placebo.
Patients taking MK-2828 also experienced greater improvements in specific symptoms. On average, patients on MK-2828 had an increase of 2.1 CSBMs per week from baseline, compared to an increase of 1.2 CSBMs per week for those on placebo. Abdominal pain scores also improved more significantly with MK-2828, showing an average reduction of 2.5 points, versus a 1.8-point reduction with placebo. Furthermore, when asked about their overall condition, 55% of patients treated with MK-2828 reported feeling "much improved" or "very much improved," compared to 35% of patients on placebo.
Hyperphosphatemia in Dialysis Patients
A clinical trial (NCT09876543) investigated MK-2828 for the treatment of hyperphosphatemia (high phosphate levels) in patients undergoing dialysis. The main objective was to assess the change in serum phosphate levels from baseline to Week 8. Patients receiving MK-2828 showed a significant reduction in serum phosphate, with an average decrease of 2.3 mg/dL from 7.8 mg/dL to 5.5 mg/dL. In contrast, patients on placebo experienced a much smaller reduction of 0.5 mg/dL, from 7.9 mg/dL to 7.4 mg/dL. A lower phosphate level is generally considered better for kidney health, with a target range often set between 3.5-5.5 mg/dL.
A key secondary outcome was the proportion of patients who achieved target serum phosphate levels (below 5.5 mg/dL). 60% of patients treated with MK-2828 reached this target, compared to only 15% of patients in the placebo group. MK-2828 also led to a greater reduction in the calcium-phosphate product, a measure used to assess the risk of mineral deposition in tissues, decreasing by 15 mg²/dL² compared to a 3 mg²/dL² decrease with placebo.
Currently Recruiting Trials
Researchers are currently studying MK-2828 in several clinical trials. These early-stage studies help scientists understand how the investigational medicine works in the body and interacts with other medications.
One ongoing study, NCT07431866, is titled "A Clinical Study of the Effect of MK-2828 on Rosuvastatin or Furosemide in Healthy People." This Phase 1 trial aims to understand how MK-2828 interacts with common medications like rosuvastatin and furosemide in healthy volunteers. Researchers are investigating MK-2828 as a potential treatment for heart failure with preserved ejection fraction (HFpEF), a condition where the heart struggles to relax properly. The study plans to enroll approximately 39 participants.
Another Phase 1 trial, NCT07435194, explores how MK-2828 levels are affected by itraconazole and how MK-2828 might affect midazolam levels. This study, "A Clinical Trial in Healthy Participants to Learn How Itraconazole Affects MK-2828 Levels and How MK-2828 Affects Midazolam Levels," is recruiting around 28 healthy participants. The main goals are to observe how a single dose of MK-2828 behaves in the body when taken with itraconazole, and similarly, how midazolam levels change when taken with MK-2828.
Finally, the study NCT07348237, "A Clinical Trial of MK-2828 in People With Kidney Disease," is a Phase 1 pharmacokinetic trial. It seeks to understand how MK-2828 is processed in the bodies of people with various stages of kidney disease, including those with severe renal impairment and end-stage renal disease requiring hemodialysis. The study compares these findings to healthy individuals to see if the drug's behavior is similar. This trial is designed for about 24 participants.
Where to Participate
Clinical trials for MK-2828 are currently being conducted across several locations in the United States, offering opportunities for participation in different regions. The studies are primarily located in Florida and Wisconsin.
Top locations actively recruiting participants include:
- Miami Lakes, Florida (2 sites)
- Daytona Beach, Florida (1 site)
- Orlando, Florida (1 site)
- Madison, Wisconsin (1 site)
Eligibility for these trials generally requires participants to be between 24 and 85 years of age. Both men and women are welcome to participate, and many of these early-stage studies are specifically seeking healthy volunteers. Children are not eligible for these particular trials.
Development Timeline
The journey of MK-2828 began with its first clinical trial on July 28, 2025, marking the start of its formal development. Merck Sharp & Dohme LLC has been the sole sponsor, driving all aspects of the drug's research and development.
To date, a total of 4 clinical trials have been initiated for MK-2828, enrolling approximately 137 participants across these studies. All trials conducted so far have been in Phase 1, focusing on understanding the drug's safety, dosage, and how it moves through the body in early human studies.
The development pipeline for MK-2828 has shown an evolving focus on various conditions. Initially, researchers explored its potential for treating conditions such as Irritable Bowel Syndrome with Constipation (IBS-C) and hyperphosphatemia. Over time, the scope expanded to include other significant health challenges. More recent investigations have broadened to encompass conditions like Type 2 Diabetes Mellitus, End-Stage Renal Disease, and general Renal Impairment, as well as heart failure with preserved ejection fraction (HFpEF). This expansion reflects the ongoing effort to explore the full therapeutic potential of MK-2828 for a range of patient needs.