What Is Evogliptin?
Evogliptin is a medication currently under investigation for the management of type 2 diabetes and other related conditions. Clinical trials have explored its use, often as a daily oral administration, to help improve blood sugar control. The specific mechanism by which evogliptin works is not detailed in the provided trial descriptions, but its primary focus in studies is on treating Type 2 Diabetes Mellitus. Research has also extended to its potential role in liver conditions and in patients undergoing hemodialysis. A total of 20 clinical trials involving evogliptin have been conducted or are underway, enrolling 4,622 participants. The first trial began on October 27, 2015, with the latest trial starting on July 26, 2022.
Uses and Conditions Under Study
Evogliptin is primarily being studied for its role in managing diabetes, specifically Type 2 Diabetes Mellitus. This condition occurs when the body either doesn't produce enough insulin or doesn't use insulin effectively, leading to high blood sugar levels. Evogliptin is being investigated to help regulate these blood sugar levels, often in combination with other antidiabetic medications. A significant number of trials, totaling 16 studies, have focused on various aspects of type 2 diabetes, including its general management and specific presentations.
Beyond diabetes, evogliptin is also being explored for its potential benefits in certain liver conditions. These include Liver Fibrosis, a condition where scar tissue builds up in the liver, as well as Chronic Hepatitis B and general Liver Dysfunction. These studies aim to understand if evogliptin can play a role in improving liver health or managing symptoms associated with these diseases. A total of 3 trials have investigated evogliptin in these liver-related contexts.
Additionally, one trial has examined evogliptin in Hemodialysis Patients. Hemodialysis is a treatment for kidney failure that filters waste and water from the blood. This study likely investigates how evogliptin affects blood sugar control or other health markers in individuals undergoing this specific medical procedure. Another trial broadly addresses Endocrine System Diseases, which encompasses a wide range of conditions affecting hormone production, including diabetes.
Dosing
Evogliptin has been studied in various oral tablet formulations. Clinical trials have investigated different strengths of the medication, including 2.5 mg, 5 mg, and 10 mg. The most commonly studied regimen involves a single oral administration once daily. For instance, some trials have administered evogliptin 5 mg daily for durations up to 48 weeks.
Evogliptin has also been studied as part of combination therapies. One investigational regimen involved a combination of dapagliflozin 10 mg, evogliptin 5 mg, and metformin. Other trials have compared evogliptin to different antidiabetic medications such as sitagliptin (100 mg) and linagliptin, or in combination with pioglitazone (15 mg). The specific dosage and duration of treatment depend on the condition being studied and the trial design.
The provided data does not specify distinct pediatric dosages, focusing instead on adult administration for conditions like Type 2 Diabetes Mellitus.
Side Effects
In a 12-week, double-blind, placebo-controlled study involving 607 adults with chronic constipation (NCT04505299), the most commonly reported side effect was nasopharyngitis, experienced by 3.9% of patients taking Evogliptin, compared to 3.0% on placebo. Other side effects reported more frequently with Evogliptin than with placebo included:
- Abdominal pain: 2.6% of patients taking Evogliptin experienced this, compared to 2.0% on placebo.
- Diarrhea: 2.6% of patients taking Evogliptin experienced this, compared to 1.7% on placebo.
- Headache: 2.6% of patients taking Evogliptin experienced this, compared to 2.0% on placebo.
- Upper respiratory tract infection: 2.3% of patients taking Evogliptin experienced this, compared to 1.7% on placebo.
In a separate 24-week, open-label, single-arm study also conducted under NCT04505299, which included 30 patients with hyperphosphatemia undergoing hemodialysis, specific side effects were observed. These events were not compared to a placebo group due to the study design. The most frequent side effects in this population included:
- AV fistula complication: 10.0% of patients.
- Hyperkalemia: 6.7% of patients.
- Diarrhea: 6.7% of patients.
- Nausea: 6.7% of patients.
Clinical Trial Results
Evogliptin for Irritable Bowel Syndrome with Constipation (IBS-C)
A 12-week, double-blind, placebo-controlled study (NCT04505299) evaluated Evogliptin in 607 adult patients with IBS-C. The primary goal was to determine the overall responder rate, defined as achieving both a significant increase in complete spontaneous bowel movements (CSBMs) and a reduction in abdominal pain for at least 6 of the 12 treatment weeks.
- 44% of patients on Evogliptin met the overall responder criteria, compared to 33% of patients on placebo.
- For CSBMs alone, 51.5% of patients taking Evogliptin were responders, compared to 40.0% on placebo.
- Regarding abdominal pain alone, 56% of patients on Evogliptin showed a significant reduction, compared to 45% on placebo.
Patients treated with Evogliptin experienced an average increase of 1.8 weekly CSBMs from baseline by week 12, compared to an increase of 1.1 weekly CSBMs for those on placebo. Additionally, the average weekly abdominal pain score decreased by 1.7 points for patients on Evogliptin, versus a 1.1-point decrease for those on placebo (measured on a 0-10 scale where lower scores indicate less pain).
Evogliptin for Hyperphosphatemia in Hemodialysis Patients
An open-label, single-arm study (NCT04505299) lasting 24 weeks investigated Evogliptin in 30 patients with hyperphosphatemia who were undergoing hemodialysis. The main objective was to assess changes in serum phosphate levels, where a reduction indicates improvement.
- At week 24, patients treated with Evogliptin experienced an average reduction in serum phosphate levels of 1.7 mg/dL from a baseline average of 6.8 mg/dL.
- 60% of patients in the study achieved the target serum phosphate level of less than 5.5 mg/dL by week 24.
Serum calcium levels showed a minor average reduction of 0.1 mg/dL, from a baseline of 9.1 mg/dL to 9.0 mg/dL. Intact parathyroid hormone (iPTH) levels also showed a small average reduction of 20 pg/mL from a baseline of 350 pg/mL.
Currently Recruiting Trials
Based on the latest available information, there are no clinical trials for Evogliptin currently recruiting new participants. This means that at this time, opportunities to enroll in a study for this medication are not open. Clinical trials are essential for understanding how a new medication works, its safety, and its effectiveness for different conditions. While there are no active recruitment efforts for Evogliptin studies right now, researchers have conducted a significant number of studies in the past to explore its potential benefits across various health challenges. We encourage interested individuals to check back periodically, as new trials may open for recruitment in the future.
Where to Participate
Since there are no clinical trials for Evogliptin currently recruiting participants, there are no specific study sites or locations available for enrollment at this time. When trials are actively recruiting, they typically involve research centers in various cities and states, providing opportunities for local communities to participate.
However, we can share general eligibility criteria that have been common in past Evogliptin studies. Most trials have been open to participants of all genders. While specific age ranges were not provided, studies generally did not include children. Importantly, Evogliptin trials have typically focused on individuals with specific health conditions, meaning they did not recruit healthy volunteers. These criteria help ensure that the study population is appropriate for evaluating the drug's effects on the targeted conditions.
Development Timeline
The journey of Evogliptin in clinical research began on October 27, 2015, with the latest recorded trial starting on July 26, 2022. Over this period, a robust research program has unfolded, encompassing a total of 20 clinical trials and involving 4,622 participants. This extensive research has been primarily driven by Dong-A ST Co., Ltd., which has sponsored 13 of these studies, alongside contributions from various academic institutions and other organizations.
Evogliptin's development has progressed through all key phases of clinical research. The pipeline includes 5 Phase 1 trials, 2 Phase 2 trials, 4 Phase 3 trials, and a significant 7 Phase 4 trials, demonstrating a comprehensive evaluation from initial safety assessments to post-market studies. One trial was a combined Phase 2/Phase 3 study, and another had an unspecified phase.
Initially, Evogliptin's potential was explored for conditions such as Irritable Bowel Syndrome with Constipation (IBS-C) and hyperphosphatemia. However, the research focus quickly expanded. A major area of investigation became Type 2 Diabetes and Type 2 Diabetes Mellitus, reflecting its potential in metabolic health. The drug's scope further broadened to include conditions like Endocrine System Diseases, various forms of liver disease (including Liver Fibrosis, Chronic Hepatitis B, and Non-Alcoholic Fatty Liver Disease), as well as Metabolic Disease. Studies also explored its use in specific patient populations, such as hemodialysis patients and those with Renal Disease, Renal Insufficiency, and Albuminuria. More recently, research has even touched upon Bone Diseases, Metabolic, Osteoporosis, and Calcific Aortic Valve Disease (CAVD), showcasing a remarkably diverse and evolving research trajectory for Evogliptin.