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Orlistat (EMP22) and Drug Combination (acarbose + orlistat) in Healthy Volunteers with Obesity

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What is this trial about?

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

Obesity is a condition where excess body weight can increase the risk of health problems such as heart disease and diabetes. The study examines a new formulation of orlistat called EMP22, which releases the medicine slowly over time, and a combination product EMP16 that contains both orlistat and acarbose. These medicines work by reducing the amount of fat that the body absorbs from food.

The purpose of the trial is to confirm that EMP22 produces the same effect as the already approved drug Xenical® in terms of how much fat is expelled in the stool, a measure known as faecal fat excretion. This type of comparison is called pharmacodynamics, which looks at what the drug does to the body.

Healthy volunteers will take the study capsules in two separate parts. In the first part, participants will receive EMP22 and Xenical® in a single‑blind crossover design, meaning they will not know which capsule they are taking each time, but the study staff will. In the second part, the focus shifts to how the body processes the medicines, referred to as pharmacokinetics, by giving EMP16 and comparing it to Xenical®. Participants will follow a short schedule of taking the capsules, providing stool samples, and having a few blood draws to assess how the medicines work and are handled by the body.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Baseline assessments
After joining the study, undergo a series of baseline measurements that may include physical examination, vital signs, and laboratory tests to document health status before any medication is taken.
Step 2
First treatment period – part i
Receive the first study medication in a single‑blind, cross‑over design. the capsule contains orlistat at a dose of 360 mg and is taken orally, typically once daily, for the duration specified by the study protocol.
During this period, collect stool over a 24‑hour interval at steady state to determine the percent of faecal fat excretion, which is the primary measurement for this part of the trial.
Step 3
Washout period
Stop taking the study medication for a period that allows the drug to be cleared from the body before starting the next treatment. no study medication is taken during this interval.
Step 4
Second treatment period – part i crossover
Receive the alternate study medication in the same single‑blind, cross‑over fashion. if the first capsule was EMP22 (modified‑release orlistat), the second capsule will be Xenical®, also containing orlistat 360 mg, taken orally once daily for the protocol‑defined duration.
Repeat the 24‑hour stool collection to measure faecal fat excretion under the second treatment condition.
Step 5
Open‑label fixed‑sequence treatment – part ii
Receive EMP16, a capsule that contains both acarbose 120 mg and orlistat 360 mg. the capsule is taken orally, usually once daily, for the duration specified in the study plan.
Blood samples are drawn at scheduled times after dosing to assess pharmacokinetic parameters such as maximum plasma concentration (Cmax), time to reach maximum concentration (Tmax), and area under the concentration‑time curve (AUC).
Step 6
Final assessments and study completion
Undergo final safety evaluations, which may include additional vital signs, laboratory tests, and a review of any adverse events that occurred during the study.
Complete all required documentation and receive a summary of participation. the trial concludes after these final assessments.

Who can join the trial?

6 criteria

Be willing and able to sign a written form that explains the study and gives your permission to take part, known as written informed consent.
Be a healthy man or woman between the ages of 20 and 55 years.
Have a body‑mass index (BMI) between 20 and 27, or if your BMI is higher than 27, have a normal amount of body fat (10‑25% for men and 20‑30% for women) measured with a special device called a bioimpedance scale.
Have a stable weight, meaning your weight has not changed by more than 5% in the three months before the screening.
Report normal bowel habits, with at least one bowel movement each day.
Be medically healthy, with no important medical problems in your history, normal physical exam findings, normal vital signs, a normal electrocardiogram (ECG), and normal laboratory test results at the screening visit.

Who cannot join the trial?

18 criteria

Having a serious illness or disorder that could put you at risk or affect the study results, such as gastrointestinal (GI) problems (e.g., inflammatory bowel disease or irritable bowel syndrome), cholestasis (reduced bile flow), previous major gut surgery (like bariatric or gallbladder surgery), vitamin B12 deficiency or low stomach acid (achlorhydria), chronic trouble absorbing nutrients (malabsorption syndrome), or severe allergy, heart (cardiac) or liver (hepatic) disease.
Taking a new investigational drug or having been in another drug trial within the past 3 months before the first dose of the study medication.
Being a current smoker or using any nicotine product (cigarettes, snuff, chewing tobacco). Occasional nicotine use less than three times a week is allowed.
Testing positive for illegal drugs or alcohol at the screening visit.
Having a history of alcohol abuse or drinking excessively, as judged by the investigator.
Having a history of drug abuse or current drug misuse, as judged by the investigator.
Having a history of using anabolic steroids (muscle‑building hormones), as judged by the investigator.
Drinking more than five cups of caffeinated beverages (about 240 mL per cup) each day.
Donating plasma within one month before screening or donating blood (or losing a similar amount of blood) in the last three months.
Being considered unlikely to follow the study procedures, restrictions, or requirements by the investigator.
Having any serious illness, medical or surgical procedure, or injury within four weeks before the first dose of the study medication.
Having had cancer (malignancy) in the past five years, except for a basal cell skin cancer that was removed in place.
Planning to have major surgery during the time the study is being conducted.
Being pregnant, currently breastfeeding, or planning to become pregnant during the study.
Testing positive for hepatitis B surface antigen, hepatitis C antibodies, or HIV at the screening visit.
Having a prolonged heart‑rate interval (QTcF greater than 450 ms), heart rhythm problems (cardiac arrhythmias), or other significant abnormalities on a resting heart test (ECG), as judged by the investigator.
Having a severe or ongoing allergy, especially to medicines similar to orlistat or acarbose.
Regularly using any prescription or over‑the‑counter medicines, supplements, herbal remedies, vitamins, or minerals within two weeks before the first dose, unless the study protocol specifically allows it.

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Investigated drugs

Orlistat
is a medicine that helps reduce the amount of fat your body absorbs from the food you eat. It works by blocking an enzyme that normally breaks down dietary fat, so some of the fat passes out of the body in the stool. In this study, orlistat is used in a special modified‑release form (called EMP22) and also as the standard brand product Xenical® for comparison.
Acarbose
is a drug that slows down the way your body breaks down carbohydrates, such as sugars and starches. By delaying this process, it helps lower the rise in blood sugar after meals. In the trial, acarbose is combined with orlistat in a single tablet (called EMP16) to see how the two medicines work together.
EMP22
is a test product that contains only orlistat in a modified‑release capsule. The capsule is designed to release the medicine slowly over time, which may affect how well it reduces fat absorption. The study compares EMP22 with the brand name product Xenical® to check if they work the same way.
EMP16
is a combination test product that includes both acarbose and orlistat in a modified‑release capsule. This formulation allows the two medicines to be taken together in one pill, so researchers can study how the combination affects fat and carbohydrate absorption compared with taking orlistat alone.
Xenical®
is the commercial brand name for orlistat. It is taken as a hard capsule that releases the drug in the intestine to block fat absorption. In the trial, Xenical® serves as the reference product to which the new modified‑release version (EMP22) is compared.

What is already known about the treatment

Orlistat
Orlistat is taken by mouth as a hard modified‑release capsule (120 mg or 360 mg) and is an approved prescription drug that has been on the market for many years. It is used to help people lose weight when combined with a reduced‑calorie diet. It works by blocking an enzyme that breaks down dietary fat, so the fat is not absorbed and is eliminated in the stool. It belongs to the class of lipase inhibitors.
Acarbose
Acarbose is taken orally as a hard modified‑release capsule (usually 100 mg or 120 mg) and is an approved medication that has been used for decades to control blood sugar. It is mainly prescribed for people with type 2 diabetes to reduce post‑meal blood‑sugar spikes. It works by slowing the breakdown of complex carbohydrates into simple sugars, which lowers the amount of glucose that enters the bloodstream after a meal. It belongs to the class of alpha‑glucosidase inhibitors.
Xenical
Xenical is taken by mouth as a hard capsule containing 120 mg of orlistat and is an FDA‑approved brand that has been on the market for many years. It is used to aid weight loss in adults with obesity when combined with a reduced‑calorie diet. It works by blocking the enzyme that breaks down dietary fat, so the fat is not absorbed and is passed in the stool. It belongs to the lipase inhibitor class.

Investigated diseases

Obesity - Obesity is a condition marked by an excess amount of body fat that accumulates to a level that may affect health. It usually develops when a person consistently consumes more calories than they expend, leading to gradual weight gain. Over time, the stored fat expands in adipose tissue, raising the body‑mass index. The increasing fat stores can make further weight loss more difficult and may promote additional weight gain. As the condition persists, metabolic adaptations can occur that sustain the excess weight.