An interventional study of orlistat 60 mg and polyglucosamine in Overweight and Obesity, sponsored by Certmedica International GmbH. Completed at 2 sites in 2 countries. Open to participants aged 21 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-08-20.
Sponsored by Certmedica International GmbH · Not applicable, Interventional, and Prevention
Among 26 studies testing orlistat in Obesity — 2 open to participants now, 2 under way, none of them phase 3. Orlistat · Obesity.
Among the 26 studies testing orlistat in Obesity, this one is the 19th largest by enrollment, is one of 3 that started in 2009, is one of 7 with no phase, and was the 21st registered.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
Browse Obesity studies →2 of the 26 studies testing orlistat in Obesity are open now, in 1 country. Recruiting first, the newest first:
Affiliated Hospital of Nantong University · Sites in China
XueMei Guo · Sites in China
By country, each count listing its studies:
Orlistat: first FDA approval 1999 (XENICAL), first EMA approval 1998. What it is approved for, and how studies give it, is on its page →
Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 168 take children under 18; 491 take healthy volunteers.
This study: 21 Years to 70 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
26 studies; the count open now beside each. This study's row is marked.
First in 1998; this study’s year is marked. 3 started in 2009.
This study's enrollment of 64 is close to the median of 67 across 9,006 interventional studies indexed under Obesity.
Median enrollment 117 across the 26 interventional studies. Of the 22 that completed or were terminated, 8 (36%) have results posted.
This tab as a report to print or save as PDF → With an account.
8 of 26 have an industry lead sponsor. The 10 most frequent:
Certmedica International GmbH is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
Certmedica International GmbH has 4 studies filed under Obesity — fewer than ten, so there is no comparison to draw.
1 of the studies testing orlistat in Obesity that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07326839XueMei GuoOrlistat and Weight Management for Uric Acid Control in Obese Gout: A RCT | 2027-11-09 |
Among the 26 studies testing orlistat in Obesity, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This trial compares two treatment methods:
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's enrollment of 64 is close to the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Certmedica International GmbH is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Overweight. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Drug: orlistat 60 mg
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
Device: polyglucosamine
In order to have comparable calorie intakes, all participants followed the recommendations of the German clinical practice guidelines on the management and prevention of obesity. Due to the different appearance of tablets and capsules, a double dummy design was chosen, a blister strip for each day and each participant had to take the same amount of capsules and tablets per day. The content of the blister strips: three orlistat 60 g capsules plus six placebo tablets.
In order to have comparable calorie intakes, all participants followed the recommendations of the German clinical practice guidelines on the management and prevention of obesity. Due to the different appearance of tablets and capsules, a double dummy design was chosen, a blister strip for each day and each participant had to take the same amount of capsules and tablets per day. The content of the blister strips: three blue placebo capsules plus two placebo tablets (morning) and four polyglucosamine tablets (noon and evening).
Number of participants in both groups with a weight reduction of >= 5 per cent compared to the initial weight.
Time frame: 12 weeks
BMI reduction
Achieved change of the BMI (cm/m²) of all participants in each group compared to the initial average BMI
Time frame: 12 weeks
Waist circumference reduction
Achieved change of the waist circumference of all participants in each group compared to the initial average WC
Time frame: 12 weeks
The record gives a start of Nov 2009, a primary completion of Jun 2010 and a completion of Aug 2013. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Orlistat
Certmedica International GmbH