An interventional study of Polyglucosamine L112 in Cholesterol Lowering, sponsored by Certmedica International GmbH. Completed at 1 site in Germany. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-18.
Sponsored by Certmedica International GmbH · Not applicable, Interventional, and Basic science
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 243rd largest by enrollment of the 273 interventional ones that give a count, is one of 12 that started in 2021, is one of 106 with no phase, and was the 193rd 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: 18 Years to 65 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. 12 started in 2021.
This study's enrollment of 30 is below 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.
Obesity is widespread and the number of overweight people has tripled from 1975 to 2016. According to the WHO (World Health Organisation), 1.9 billion adults worldwide are overweight, of which 650 million are obese. Thus, obesity is caused by a balance problem between the amount of food consumed and the energy used. The weighting of the diet in favour of a far too high fat intake also has a negative influence on the fat metabolism.
Obesity is associated with a number of secondary diseases, such as diabetes mellitus, increased inflammatory parameters in the blood and a higher risk of heart attack and stroke. These secondary diseases reduce the quality and duration of life of the person affected.
In animal studies, polyglucosamine was found to have a cholesterol-lowering effect. In human studies conducted over 3 and 12 months, formoline L112 was shown to lower LDL levels in the blood.
For research purposes, the present study will focus on investigating whether the intake of polyglucosamine L112 leads to a reduction in cholesterol intake from food, which should result in a reduced fat and thus calorie intake.
In the present study, the influence of polyglucosamine L112 on cholesterol absorption in humans is to be investigated in more detail.
For this purpose, the subjects undergo two randomised study periods in a crossover design: first, there is a 2-week run-in phase, during which baseline values are collected without influence, then the subjects undergo two identical study periods, during which the subjects randomly take either polyglucosamine L112 or placebo twice a day. The study periods are separated by a two-week washout phase. After two weeks, a final examination takes place.
Throughout the course of the study, lipids in the serum are measured regularly. In order to examine cholesterol absorption, however, it is not sufficient to determine the cholesterol levels in the blood, as reduced absorption is physiologically compensated for by increased endogenous synthesis.
In the present study, the plant sterol campesterol, which is absorbed from the intestine like cholesterol, is determined as a surrogate marker for cholesterol absorption. At the same time, a surrogate marker for endogenous cholesterol synthesis is determined with lathosterol, which behaves like the endogenously synthesised cholesterol in terms of concentration. However, campesterol must also be set in relation to cholesterol via the campesterol-cholesterol quotient, since the concentration of campesterol is also dependent on the concentration of LDL lipoproteins as transport molecules, which reacts in the same way as the cholesterol concentration. Accordingly, a lower value of the campesterol-cholesterol quotient indicates reduced cholesterol absorption.
The values corrected for total cholesterol then give an overview of the endogenous cholesterol synthesis for the cholesterol precursors, that of the plant sterols via the cholesterol resorption rate in the small intestine and that of the oxysterols via the bile acid synthesis rate.
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:
Exception: Participation in the study is possible if medicinal products for which an interaction is to be expected or cannot be ruled out can be taken at least 4 hours apart from polyglucosamine L112. I.e. since the test product must be taken with the main meals, participation in the study can only take place if it is not necessary to take it with the two main meals.
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
composed of (beta-1.4 polymer of D-glucosamine and N-acetyl-D-glucosamine)
Device: Polyglucosamine L112
Dicalcium phosphate, cellulose
Device: Polyglucosamine L112
Two tablets once daily per os
Influence of polyglucosamine L112 on dietary cholesterol absorption
Comparison of the campesterol-cholesterol quotient taking polyglucosamine L112 versus placebo
Time frame: 10 weeks
Influence of polyglucosamine L112 on surrogate markers of cholesterol
Comparison of the ratio of sitosterol to cholesterol (cholesterol absorption)
Time frame: 10 weeks
Influence of polyglucosamine L112 on cholesterol synthesis
Comparison of the ratio of lathosterol to cholesterol
Time frame: 10 weeks
Influence of polyglucosamine L112 on bile acid synthesis
Comparison of the ratio of 7a- and 27-hydroxycholesterol to cholesterol
Time frame: 10 weeks
Influence of polyglucosamine L112 on neutral fecal sterols
Comparison of the content of neutral sterols (cholesterol and bacterial degradation products coprostanol and coprostanone)
Time frame: 10 weeks
Fecal primary and secondary bile acids
Comparison of the content of bile acids in the stool (cholic acid, deoxycholic acid, chenodeoxycholic acid, lithocholic acid and ursodeoxycholic acid)
Time frame: 10 weeks
Cholesterol measurements
Comparison of total cholesterol (C), HDL-C, and LDL-C and triglycerides in serum
Time frame: 10 weeks
Change in body weight
Comparison of body weight taking polyglucosamine L112 versus placebo
Time frame: 10 weeks
Safety and tolerability (i.e. incidents of treatment-emergent adverse events) of polyglucosamine L112
Comparison of incidence of adverse events with polyglucosamine L112 versus placebo
Time frame: 10 weeks
Plan to share: No
No publications or documents are linked to this record.
Ran from Sep 2021 to primary completion in Jun 2022, 9 months.
Of 163 industry-sponsored interventional studies with no phase under Obesity, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 27. This study's 9 months is below that.
Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Certmedica International GmbH