An interventional study of Polyglucosamine and Placebo in Overweight and Obesity, sponsored by Certmedica International GmbH. Completed at 2 sites in 2 countries. Open to participants aged 21 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-01-28.
Sponsored by Certmedica International GmbH · Not applicable, Interventional, and Treatment
Among 333 studies in Obesity with a site in Germany — 70 open to participants now, 105 under way, 47 of them phase 3. Obesity · Germany.
Among the 333 studies in Obesity with a site in Germany, this one is the 164th largest by enrollment of the 273 interventional ones that give a count, is one of 8 that started in 2009, is one of 106 with no phase, and was the 97th registered.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
Browse Obesity studies →70 of the 333 studies in Obesity with a site in Germany are open now. Recruiting first, the newest first:
Eli Lilly and Company · Sites in Germany, United States, Brazil and 7 more countries
Technical University of Munich · Sites in Germany
Novo Nordisk A/S · Sites in Germany
Boehringer Ingelheim · Sites in Germany
German Diabetes Center · Sites in Germany
A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →
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 75 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.
333 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 46 · Phase 2 27 · Phase 3 87 · Phase 4 12
First in 1998; this study’s year is marked. 8 started in 2009.
This study's enrollment of 115 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Median enrollment 158 across the 273 interventional studies, 165 across the 60 observational. Of the 198 that completed or were terminated, 31 (16%) have results posted.
This tab as a report to print or save as PDF → With an account.
171 of 333 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.
36 of the studies in Obesity with a site in Germany that are under way reach primary completion within a year, 15 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06662383Phase 3Eli Lilly and CompanyA Study of Retatrutide (LY3437943) Compared to Tirzepatide (LY3298176) in Adults Who Have Obesity | 2026-11 |
| NCT06914895Phase 3Eli Lilly and CompanyA Study of Tirzepatide (LY3298176) Compared With Placebo in Adults With Type 1 Diabetes and Obesity or Overweight | 2026-11 |
| NCT06858839Phase 3AmgenEvaluation of Maridebart Cafraglutide in Adult Participants Without Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight | 2027-01-21 |
| NCT06858878Phase 3AmgenEfficacy and Safety of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight | 2027-01-21 |
| NCT07220642Phase 3Novo Nordisk A/SWeight Loss in People Living With Overweight or Obesity Following Treatment With Cagrilintide | 2027-05-11 |
Among the 333 studies in Obesity with a site in Germany, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The polyglucosamine, specification L112 is a medical device and in this clinical trial used for weight reduction of overweight and obese participants. The rationale for this study is to show that overweight can be reduced by taking 2 times daily 2 tablets with the main meals with the highest fat content.
To have a comparable diet condition, all participants in both groups had to follow the recommendations of the German clinical practice guidelines on the management and prevention of obesity.
One group had to take the polyglucosamine tablets and the other group placebo tablets for at least 24 weeks. It is known, that polyglucosamine is a fat binder acting in a physical-chemical manner, the positive charged fiber is bound to the negative charged dietary fat and this complex in unable to pass the gut wall into the body but is naturally excreted, hence this energy is not available. Therefore, this medical device should show a measurable reduction in body weight.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's enrollment of 115 is above 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.
2 times daily 2 tablets with the two main meals with the highest fat content. Participants follow the German guideline with a hypo-caloric (-500 kcal daily) lifestyle and increased physical activity.
Device: Polyglucosamine
2 times daily 2 tablets with the two main meals with the highest fat content. Participants follow the German guideline with a hypo-caloric (-500 kcal daily) lifestyle and increased physical activity.
Other: Placebo
ß-1,4 polymer of D-glucosamine and N-acetyl-D-glucosamine from the shells of crustaceans
Placebo tablet
Number of participants who could reduce their body weight by 5 or more per cent compared to the initial body weight.
Time frame: 24 weeks
Change of body weight in kg
Time frame: 24 weeks
Change of BMI
Time frame: 24 weeks
Reduction of waist circumference
Time frame: 24 weeks
Plan to share: No
The record gives a start of Aug 2009, a primary completion of Oct 2009 and a completion of Oct 2010. 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 Mar 2015. You cannot join it, but the record below documents what was studied.
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Certmedica International GmbH