A Phase 4 interventional study of Polyglucosamine L112 and Placebo in Weight Loss, sponsored by Certmedica International GmbH. Completed at 1 site in Italy. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-22.
Sponsored by Certmedica International GmbH · Phase 4, Interventional, and Treatment
Among 37 studies in Weight Loss with a site in Italy — 10 open to participants now, 11 under way, 2 of them phase 3. Weight Loss · Italy.
Among the 37 studies in Weight Loss with a site in Italy, this one is the 6th largest by enrollment of the 29 interventional ones that give a count, is one of 2 that started in 2020, is one of 2 in phase 4, and was the 21st registered.
1,815 studies on the registry are indexed under Weight Loss; 294 are open to participants now.
Browse Weight Loss studies →10 of the 37 studies in Weight Loss with a site in Italy are open now. Recruiting first, the newest first:
CatalYm GmbH · Sites in Italy, United States, Bulgaria and 11 more countries
Lionhealth Srl Società Benefit · Sites in Italy
Pharmanutra S.p.a. · Sites in Italy
San Raffaele Telematic University · Sites in Italy
Pfizer · Sites in Italy, United States, Australia and 18 more countries
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 196 Weight Loss studies recruiting now, 71 (36%) set no upper age limit and 108 (55%) stop at 75 or younger; 21 take children under 18; 58 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.
37 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 2 started in 2020.
This study's enrollment of 150 is above the median of 80 across 1,561 interventional studies indexed under Weight Loss.
Median enrollment 83 across the 29 interventional studies, 130 across the 8 observational. Of the 23 that completed or were terminated, 1 (4%) have results posted.
This tab as a report to print or save as PDF → With an account.
14 of 37 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 5 studies filed under Weight Loss — fewer than ten, so there is no comparison to draw.
4 of the studies in Weight Loss with a site in Italy that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07393360Pharmanutra S.p.a.Effect of a Food for Special Medical Purposes on Muscle Mass Preservation During GLP-1 RAs Weight Loss Treatment | 2026-12 |
| NCT07433946Lionhealth Srl Società BenefitPartial Enteral Nutrition to Prevent Weight Loss and Sarcopenia in IBD Patients at Nutritional Risk - SIMBA | 2026-12-15 |
| NCT06309563Istituto Auxologico ItalianoMetabolic Effects of a Diet Replaced With Essential Amino Acids | 2026-12-31 |
| NCT07229170San Raffaele Telematic UniversityChanges in Taste and Eating Habits Associated With GLP-1 Agonists in Weight Loss Patients | 2027-01-01 |
Among the 37 studies in Weight Loss with a site in Italy, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of the study is to evaluate the effect on weight loss in a group of subjects suffering from overweight and mild obesity (BMI between 25 and 32 Kg/m2) and with weight > 75 Kg/m2 being administered with a 3 g/day polyglucosamine dosage.
The primary objective of the study is to evaluate the effect on weight loss in a group of subjects suffering from overweight and mild obesity (BMI between 25 and 32 Kg/m2) and with weight > 75 Kg/m2 being administered with a 3 g/day polyglucosamine dosage.
The secondary objectives of the study are:
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.
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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
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.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
75 subjects of both sexes suffering from overweight and mild obesity BMI 25-32 and weigh in \> 75 kg
Drug: Polyglucosamine L112
75 subjects of both sexes suffering from overweight and mild obesity BMI 25-32 and weigh in \> 75 kg
Other: Placebo
Polyglucosamine; Ascorbic Acid; Tartaric Acid
Also known as: Formoline L112
Dicalcium Phosphate; Microcrystalline Cellulose; Iron Oxide (yellow, brown, and black); Magnesium Stearate; Silicon Dioxide
Weight Loss
To evaluate the weight loss with 3 g/die administration of polyglucosamine (PG)
Time frame: 3-month treatment
Triglycerides
To evaluate the effect of PG administration on triglycerides plasma levels
Time frame: 3-month treatment
Cholesterol
To evaluate the effect of PG administration on total cholesterol plasma levels
Time frame: 3-month treatment
HOMA
To evaluate the effect of PG administration on glucose, insulin, insulin resistance (measured through Homeostatic Metabolic Assessment - HOMA
Time frame: 3-month treatment
Hepatic Enzymes - Renal Functionality
To evaluate the effect of PG administration on transaminases and creatinine
Time frame: 3-month treatment
BMI
To evaluate the effect of PG administration on BMI
Time frame: 3-month treatment
Abdominal Circumference
To evaluate the effect of PG administration on the abdominal circumference
Time frame: 3-month treatment
DXA
To evaluate the effect of PG administration on corporeal composition by means of DXA (Dual energy X-ray Absorptiometry)
Time frame: 3-month treatment
ROS
To evaluate the effect of PG administration on ROS (Reactive Oxygen Species) serum levels
Time frame: 3-month treatment
Antioxidant Serum Capacity
To evaluate the effect of PG administration on serum antioxidant capacity
Time frame: 3-month treatment
Ran from Apr 2020 to primary completion in Dec 2021, 19 months.
Of 45 phase 4 interventional studies under Weight Loss, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 46. This study's 19 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Certmedica International GmbH