Completed

Orlistat 60 mg vs Customized Polyglucosamine for Overweight and Obesity Management

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
Study Aim

This study aims to compare the effectiveness of Orlistat 60 mg and customized Polyglucosamine in helping overweight and obese individuals achieve a weight reduction of 5% or more from their initial weight.

What is being tested

orlistat 60 mg

+ polyglucosamine

DrugDevice
Who is being recruted

Body Weight+7

+ Body Weight Changes

+ Nutrition Disorders

From 21 to 70 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: November 2009
See protocol details

Summary

Principal SponsorCertmedica International GmbH
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2009

Actual date on which the first participant was enrolled.

A study is comparing two treatments for overweight and obesity management: Orlistat 60 mg and customized Polyglucosamine. Orlistat is a capsule taken three times a day, while Polyglucosamine is a tablet taken twice daily with the two main meals containing the highest fat content. Both treatments aim to aid weight loss in overweight adults, with Orlistat used alongside a reduced-calorie and low-fat diet. The purpose of this research is to find an effective prevention method for overweight and obesity, addressing a significant health challenge. Participants in this study will be divided into two groups, each receiving one of the two treatments. The primary outcome measured is the number of participants in both groups who achieve a weight reduction of 5 percent or more compared to their initial weight. This comparison helps determine the effectiveness of each treatment method in managing overweight and obesity.

Official TitleRandomized, Double-blind, Clinical Investigation to Compare Orlistat 60 mg and a Customized Polyglucosamine, Two Treatment Methods for the Management of Overweight and Obesity
Principal SponsorCertmedica International GmbH
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

64 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 21 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body WeightBody Weight ChangesNutrition DisordersNutritional and Metabolic DiseasesObesitySigns and SymptomsPathological Conditions, Signs and SymptomsWeight LossOvernutritionOverweight

Criteria

2 inclusion criteria required to participate
BMI ≥ 28 kg/m² and < 45 kg/m²

Waist circumference > 80 cm (women) > 94 cm (men)

8 exclusion criteria prevent from participating
Chronic diseases not under control with adequate therapy

Diabetes

Energy intake lower than the standard value according to Miffin St-Jeor equation

Pregnancy or breast-feeding

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
A tailored blister-strip for one day contains * three capsules with orlistat 60mg Administration: 3 times daily 1 capsule with each meal containing fat concomitant with * six placebo tablets Administration: 3 times daily 2 tablets with each main meal

Group II

Active Comparator
A tailored blister-strip for one day contains * three placebo capsules Administration: 3 times daily 1 capsule with each meal containing fat concomitant with * six tablets Administration: 3 times daily 2 tablets (whereas the 2 tablets in the mold "breakfast" are placebo tablets and the remaining 4 tablets for lunch and dinner contains poliglucosamine

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

Diabetological Center

Dreieich, GermanyOpen Diabetological Center in Google Maps
Suspended

MAP Center

Rende, Italy
Completed2 Study Centers