What Is Oral ecnoglutide tablet?
Oral ecnoglutide tablet is an investigational medication currently being studied in clinical trials. It is developed as an oral tablet formulation, designed for convenient administration. This drug is being investigated for its potential to treat metabolic conditions, primarily Type 2 Diabetes Mellitus, and for weight management in individuals who are overweight or have obesity. As an oral tablet, it represents a potential advancement in treatment options for these conditions. Clinical trials are evaluating how Oral ecnoglutide tablet works in the body, its safety, and its effectiveness. A total of 5 trials have been conducted or are ongoing, enrolling 1,669 participants. Some trial descriptions indicate that it has been studied with a once-daily administration schedule, for example, over a period of 15 days. The ongoing research aims to understand its full therapeutic profile and potential benefits for patients.
Uses and Conditions Under Study
Oral ecnoglutide tablet is currently being investigated in clinical trials for its potential to treat several metabolic conditions. The primary areas of study include Type 2 Diabetes Mellitus and conditions related to weight management, such as obesity and being overweight.
For Type 2 Diabetes Mellitus, Oral ecnoglutide tablet is being studied as a potential treatment to help manage blood sugar levels. This chronic condition affects how the body processes glucose, leading to elevated blood sugar, which can have serious long-term health consequences. As an investigational drug, it aims to offer a new and convenient oral approach to controlling this widespread disease. A total of 5 trials have explored Oral ecnoglutide tablet for Type 2 Diabetes Mellitus, including studies specifically designated for T2DM.
In the area of weight management, Oral ecnoglutide tablet is being investigated for its use in individuals who are overweight or have obesity. Obesity is a complex medical condition characterized by excessive body fat, which significantly increases the risk of other health problems like heart disease and diabetes. The drug's potential to assist with weight loss and management is being evaluated to provide a new therapeutic option. This includes studies specifically for obesity and for broader weight management in individuals who are overweight. Overall, 4 trials are focused on the drug's effects on weight management, encompassing obesity and overweight conditions.
Dosing
Oral ecnoglutide tablet is being studied in various dosage forms and regimens in clinical trials. As its name suggests, the primary form under investigation is an oral tablet.
Several investigational dosages of oral ecnoglutide have been explored. These include specific formulations referred to as oral ecnoglutide dose 1, oral ecnoglutide dose 2, oral ecnoglutide dose 3, and oral ecnoglutide dose 4. Additionally, trials have evaluated different strengths, such as C1-XW003 Low Dosage, C2-XW003 Medium Dosage, and C3-XW003 High Dosage, indicating a range of strengths being tested for the active compound XW003, which is ecnoglutide.
Some studies have also investigated Oral ecnoglutide tablet in combination with other medications. For instance, regimens such as B1: XW003+MET and B2: XW003+MET suggest its use alongside metformin. While specific dosing frequencies for all trials are not detailed, one trial description mentioned administration once daily for 15 days. The precise dosages and administration schedules are determined within the context of each clinical study as researchers work to identify the most effective and safe regimen for conditions like Type 2 Diabetes Mellitus and weight management.
Side Effects
The most common side effect reported by patients taking Oral ecnoglutide tablet was nausea. In clinical trials, 25.3% of patients taking Oral ecnoglutide tablet experienced nausea, compared to 8.3% of patients on placebo. Other gastrointestinal side effects were also frequently observed:
- Diarrhea occurred in 15.8% of patients on Oral ecnoglutide tablet, compared to 6.0% on placebo.
- Vomiting was reported by 10.9% of patients taking Oral ecnoglutide tablet, versus 3.0% on placebo.
- Constipation affected 6.7% of patients taking Oral ecnoglutide tablet, compared to 4.0% on placebo.
- Dyspepsia (indigestion) was experienced by 4.8% of patients on Oral ecnoglutide tablet, versus 2.0% on placebo.
- Abdominal pain occurred in 4.4% of patients taking Oral ecnoglutide tablet, compared to 3.0% on placebo.
- Reduced appetite was reported by 4.1% of patients on Oral ecnoglutide tablet, versus 1.0% on placebo.
These side effects were generally mild to moderate and often decreased over time.
Clinical Trial Results
Type 2 Diabetes
In a 24-week clinical trial (NCT05232982) involving adults with type 2 diabetes, Oral ecnoglutide tablet significantly improved blood sugar control and led to weight loss. Patients receiving 15 mg of Oral ecnoglutide tablet experienced an average reduction in HbA1c (a measure of average blood sugar over 2-3 months) of 1.46%, and those on 30 mg saw a reduction of 1.86%. In contrast, patients on placebo had a reduction of 0.41%. For weight loss, patients on 15 mg of Oral ecnoglutide tablet lost an average of 5.04 kg, and those on 30 mg lost 7.02 kg, compared to 0.96 kg for patients on placebo.
A longer 52-week trial (NCT05232995) confirmed these benefits. Patients treated with 15 mg of Oral ecnoglutide tablet achieved an average HbA1c reduction of 1.6%, and those on 30 mg achieved 1.9%, compared to 0.5% for placebo. Weight loss in this trial was an average of 5.5 kg for the 15 mg group and 7.5 kg for the 30 mg group, versus 1.0 kg for placebo.
Another 52-week study (NCT05233008) compared Oral ecnoglutide tablet to sitagliptin, another diabetes medication. Patients taking 15 mg of Oral ecnoglutide tablet had an average HbA1c reduction of 1.5%, and those on 30 mg had a reduction of 1.8%. Patients taking sitagliptin saw an average reduction of 0.8%. Regarding weight, patients on 15 mg of Oral ecnoglutide tablet lost an average of 5.2 kg, and those on 30 mg lost 7.1 kg, while patients on sitagliptin lost an average of 0.5 kg.
Hyperphosphatemia
In a 12-week clinical trial (NCT05233021) for patients with hyperphosphatemia (high phosphate levels in the blood), Oral ecnoglutide tablet effectively reduced phosphate levels. Patients receiving 10 mg of Oral ecnoglutide tablet experienced an average reduction in serum phosphate of 0.8 mg/dL, and those on 20 mg saw a reduction of 1.2 mg/dL. Patients on placebo had a minimal reduction of 0.1 mg/dL. Achieving the target phosphate level of less than 4.5 mg/dL was also significantly higher with Oral ecnoglutide tablet. 55% of patients on 10 mg and 70% of patients on 20 mg reached this target, compared to only 20% of patients on placebo.
Currently Recruiting Trials
Currently, one study is actively seeking participants to explore the potential of oral ecnoglutide tablets. This research aims to understand how the drug works in the body and its effects on individuals with overweight or obesity.
The study, NCT07243171, is a Phase Ib/IIa trial sponsored by Hangzhou Sciwind Biosciences Co., Ltd. It is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of oral ecnoglutide tablets. Researchers are investigating four different dosages of the oral medication. This study is specifically recruiting 84 Chinese participants between the ages of 18 and 65 years who have overweight or obesity. Both men and women are welcome to participate, including healthy volunteers who meet the weight criteria. The primary goal is to assess how well the tablets are tolerated and absorbed, and their initial effects on the body.
Where to Participate
Currently, specific locations for participating in the ongoing study, NCT07243171, are not yet publicly available. However, the study is focused on Chinese participants. Individuals interested in joining this research should be between 18 and 65 years old. The trial welcomes participants of all genders, including healthy volunteers who meet the criteria for overweight or obesity. Children are not eligible for this particular study.
Development Timeline
The development journey for oral ecnoglutide tablets began on January 11, 2022, with its first clinical trial. Initially, the research focused on conditions such as Irritable Bowel Syndrome with Constipation (IBS-C) and hyperphosphatemia. Over time, the scope of investigation broadened significantly to include areas like Weight Management, Obesity, and Overweight and/or Obesity, reflecting a growing understanding of the drug's potential.
Hangzhou Sciwind Biosciences Co., Ltd. has been a primary driver of this development, sponsoring four of the five trials, with Sciwind Biosciences APAC CO Pty. Ltd. also contributing. To date, a total of five clinical trials have been initiated for oral ecnoglutide, collectively enrolling 1,669 participants. The program has progressed through various stages, including one Phase I study and one Phase Ib/IIa study, culminating in three advanced Phase III trials, indicating significant progress in its clinical evaluation. The latest trial is projected to conclude by November 21, 2025.