A Phase 3 interventional study of Obex and Placebo in Overweight and Obesity, sponsored by Catalysis SL. Completed at 1 site in Cuba. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-10-21.
Sponsored by Catalysis SL · Phase 3, Interventional, and Treatment
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's enrollment of 160 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Catalysis SL is the lead sponsor of 53 studies on the registry; 4 are 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.
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.
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.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
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.
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.
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.
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.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
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.
a nutritional supplement Obex® 8 g daily by oral route divided into two doses of 4g (between 15 and 20 minutes before lunch and dinner) diluted in water or juice for 6 months. Patients will be recommended to comply with a healthy lifestyle through diet and exercise.
Dietary Supplement: Obex
Placebo 8 g daily by oral route divided into two doses of 4g (between 15 and 20 minutes before lunch and dinner) diluted in water or juice for 6 months. Patients will be recommended to comply with a healthy lifestyle through diet and exercise.
Dietary Supplement: Placebo
After concluded the six months of treatment, patients will be follow-up during six months without consumption of Obex
After concluded the six months of treatment, patients will be follow-up during six months without consumption of the placebo.
Change From Baseline in Body Weight.
Change in body weight from baseline (0) after six months of treatment (i.e., weight at six month minus weight at baseline 0). Body weight measured in kilograms (k).
Time frame: Six months
Change From Baseline in Waist Circumference at Week 24.
Change in waist circumference from baseline after six months of treatment (i.e., waist circumference at six month minus waist circumference at baseline 0). Waist measured in centimeters (cm).
Time frame: Six months
To evaluate the effect of Obex® on fasting glucose levels.
The primary outcome is to evaluate the effect of the treatment with Obex® on fasting glucose levels by blood analysis.
Time frame: Six months
To evaluate the effect of Obex® on Body Mass Index (BMI).
The BMI will be measured by Quételet index.
Time frame: Six months
To evaluate the effect of Obex® on the waist and hip ratio.
Waist and hip ratio will be measured according to the World Health Organisation's data gathering protocol.
Time frame: Six months
To evaluate the effect of Obex® on the waist and height ratio.
Waist and height ratio will be measured.
Time frame: Six months
To evaluate the effect of Obex® on arterial blood pressures (BP).
The arterial BP will be evaluated by the doctor.
Time frame: Six months
To evaluate the effect of Obex® on fasting insulin levels.
The insulin levels will be evaluated by blood analysis.
Time frame: Six months
To evaluate the effect of Obex® on insulin resistance.
Homeostasis model assessment-estimated insulin resistance (HOMA-IR), calculated from individual serum measures (fasting insulin x fasting glucose/22.5).
Time frame: Six months
To evaluate the effect of Obex® on insulin sensitivity.
The Quicki, Bennett and Raynaud insulin sensitivity indexes will be evaluated by QUICKI = \[1/\[log I0 + log G0\], Bennett index (BEN) = 1/(log I0 x log G0), Raynaud index (RAY) = \[40/I0\]).
Time frame: Six months
To evaluate the effect of Obex® on β-cell function.
Homeostatic model assessment-beta cell (HOMA-β), calculated from individual serum measures (20 x fasting insulin (µU/mL)/fasting glucose (mmol/L)-3.5).
Time frame: Six months
To evaluate the effect of Obex® on cholesterol.
The cholesterol, triglyceride, HDL-c and LDL-c levels will be evaluated by blood analysis.
Time frame: Six months
To evaluate the effect of Obex® on hepatic enzymes.
The hepatic enzymes (Alanine aminotransferase, Aspartate aminotransferase, gamma-glutamyltransferase, Alkaline Phosphatase) will be evaluated by blood analysis.
Time frame: Six months
To evaluate the effect of Obex® on creatinine and uric acid concentrations.
The creatinine and uric acid levels will be evaluated by blood analysis.
Time frame: Six months
To evaluate the effect of Obex® on haemoglobin levels.
The haemoglobin levels will be evaluated by blood analysis.
Time frame: Six months
To evaluate the effect of Obex® on Conicity Index (CI)
CI will be measured by index.
Time frame: Six months
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
No publications or documents are linked to this record.
Ran from Oct 2018 to primary completion in Sep 2019, 11 months.
Of 198 industry-sponsored phase 3 interventional studies under Obesity, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 27. This study's 11 months is below that.
Counting every sponsor, half of 261 studies reached it within 24 months; a quarter within 18 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.