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

1 1 1

What is this study about?

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.

Who Can Join the Study?

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
CTC Clinical Trial Consultants AB Uppsala Sweden

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Sweden Sweden
Not recruiting
01.09.2023

Trial locations

Investigated drugs:

Investigated diseases:

Trial ID:
2023-505671-74-00
Protocol code:
EP-004
Trial Phase:
Human Pharmacology (Phase I) – Bioequivalence Study

Other Trials to Consider

  • Zenagamtide Compared with Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Croatia Germany Hungary Poland Portugal +1
  • RO7795068 for Weight Loss in Adults With Obesity or Overweight and Type 2 Diabetes

    Recruiting

    1 1
    Investigated diseases:
    Czechia France Germany Hungary Italy Poland +2