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Study on the Effects of EMP16 and Ispaghula Husk for Obesity in Adults

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of obesity, a condition characterized by excessive body weight that can lead to various health issues. The study will use a combination of medications, including a new treatment called EMP16, which contains the active substances acarbose and orlistat. Additionally, the trial will involve a product called Vi-Siblin S granulat, which contains ispaghula husk, a type of dietary fiber. The study will also compare these treatments with a conventional form of orlistat and a placebo dietary fiber supplement.

The purpose of the study is to compare how well the combination of EMP16 and Vi-Siblin S is tolerated by participants compared to the conventional orlistat and placebo. Participants will take these treatments orally, meaning they will swallow them. The study will last for a period of up to 39 weeks, during which participants will gradually increase their doses to find the most suitable amount for their needs. Throughout the study, participants will be monitored for any side effects, particularly those related to the digestive system, such as oily spotting, diarrhea, and fecal incontinence.

This trial aims to provide valuable information on the effectiveness and tolerability of the new treatment combination for managing obesity. By comparing the new treatment with existing options, researchers hope to find a more effective way to help individuals manage their weight and improve their overall health.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the trial
Upon joining the trial, you will be provided with detailed information about the study, including its purpose and the procedures involved. You will be asked to provide written consent to confirm your willingness to participate.
Step 2
Initial assessment
An initial assessment will be conducted to ensure you meet the eligibility criteria. This includes checking your body mass index (BMI) and reviewing your medical history for any gastrointestinal (GI) issues experienced in previous treatments.
Step 3
Medication administration
You will be assigned to receive either a combination of EMP16 plus Vi-Siblin S or conventional orlistat plus a placebo dietary fiber supplement. The medications will be taken orally in the form of capsules or granules.
The dosage and frequency of the medications will be explained to you by the study team. It is important to follow the instructions carefully for the duration of the trial.
Step 4
Monitoring and follow-up
Throughout the trial, you will be monitored for any side effects or changes in your health. Regular follow-up visits will be scheduled to assess your progress and address any concerns.
You will be asked to report any GI symptoms such as oily spotting, fecal incontinence, or diarrhea, as these are important for evaluating the tolerability of the treatment.
Step 5
Completion of the trial
At the end of the trial, a final assessment will be conducted to evaluate the overall effects of the treatment. You will be informed about the results and any further steps if necessary.

Who can join the trial?

7 criteria

Willing and able to give written informed consent for participation in the trial.
Have experienced GI tolerability issues (such as oily spotting, trouble controlling bowel movements, and/or moderate to severe diarrhea) in previous trials using EMP16 or conventional orlistat, either in clinical trials or regular treatment for obesity.
Must be a male or female aged 18 years or older.
Have a Body Mass Index (BMI) of 30 or higher, or 27 or higher if there are other risk factors like high blood pressure, high blood sugar, type 2 diabetes managed with lifestyle changes (no medication), and/or abnormal cholesterol levels. If needed, blood tests for cholesterol and other fats can be done to check eligibility.
No significant health issues found during a physical exam, vital signs check, heart test (ECG), and lab tests at the screening visit, as determined by the study doctor.
Have adequate kidney function, meaning creatinine levels are less than 1.5 times the upper limit of normal.
Have adequate liver function, meaning certain liver enzymes (AST, ALT, ALP, and GGT) are less than 2.5 times the upper limit of normal, and bilirubin is less than 1.5 times the upper limit of normal.

Who cannot join the trial?

3 criteria

Patients who are not diagnosed with obesity cannot participate.
Patients who are not within the specified age range cannot participate.
Patients who are part of a vulnerable population cannot participate.

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Uppsala, Sweden

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Investigated drugs

EMP16
is a new medication being tested in this clinical trial. It is not yet widely known or available, as it is still in the research phase. The purpose of this trial is to see how well people can tolerate this medication when its dose is gradually increased. Researchers are trying to understand if it can be a safe and effective option for patients in the future.
Vi-Siblin® S
is a type of dietary fiber supplement. In this trial, it is used in combination with EMP16. Dietary fiber supplements like Vi-Siblin® S are often used to help with digestion and to maintain regular bowel movements. In this study, it is being tested to see if it can help improve the tolerability of EMP16 when taken together.
Orlistat
is a medication that is commonly used to help people lose weight. It works by reducing the amount of fat that your body absorbs from the food you eat. In this trial, orlistat is used as a comparison to see how well the new medication, EMP16, works in combination with Vi-Siblin® S. Researchers want to find out if the new combination is better tolerated than orlistat with a placebo dietary fiber supplement.

What is already known about the treatment

EMP16
EMP16 is administered orally and is currently being studied in clinical trials for its potential use in treating obesity. It is in the early stages of research, specifically in a dose-escalation trial, to prepare for more extensive Phase III trials. The main goal of using EMP16 is to help manage weight by potentially altering how the body processes and stores fat. It is classified as an anti-obesity medication, and its exact mechanism of action at the molecular level is still under investigation, but it is believed to work by affecting the digestive system and metabolism.
Vi-Siblin® S
Vi-Siblin® S is taken orally and is used as a dietary fiber supplement. It is being tested in combination with EMP16 in clinical trials to assess its effectiveness in improving the tolerability of weight management treatments. This supplement is already known in medical literature for its role in aiding digestion and promoting regular bowel movements. It works by absorbing water in the intestines, which helps to soften stools and make them easier to pass, and is classified as a bulk-forming laxative.

Investigated diseases

Obesity – Obesity is a condition characterized by excessive body fat accumulation that may impair health. It develops when there is an imbalance between calories consumed and calories expended, leading to energy storage in the form of fat. Over time, this excess fat can accumulate in various parts of the body, including under the skin and around internal organs. As obesity progresses, it can lead to increased strain on the body's systems, potentially affecting mobility and physical function. The condition is often associated with metabolic changes, such as insulin resistance and inflammation. Obesity can also contribute to the development of other health issues, such as cardiovascular diseases and type 2 diabetes.