CompletedNCT02145442Updated May 8, 2018

Effects of Obex in Overweight and Obese Patients

A Phase 2/3 interventional study of Obex in Overweight and Obesity, sponsored by Catalysis SL. Completed at 1 site in Cuba. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-05-08.

Primary conditionObesityRegistry: OverweightReclassifiedWhy we changed it

Registry

Overweight — the first condition term the registry derived for this study.

ClinicalTrials.gg

Obesity

Why

The study's listed conditions name Obesity, a narrower term within Overweight.

Confidence

High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →

Wrong?

Tell us the study's main condition →

Sponsored by Catalysis SL · Phase 2/3, Interventional, and Treatment

Phase: Phase 2/3
Study type: Interventional
Enrollment: 40
Allocation: Not applicable
Ages: 20 Years to 60 Years
Sex: All

Study summary

Obesity is an important and growing public health worldwide
Obesity is highly related to the development of metabolic syndrome, diabetes, cardiovascular diseases and cancer
An extensive body of evidence from efficacy trials has shown that weight loss is achievable, however, a modest weight loss is achieved in a small proportion of patients
Important adverse events have been reported with the use of antiobesity drugs.
The use of natural products with potential effects inducing weight loss is an alternative strategy for treating patients with overweight and obesity. However, efficacy and safety should be evaluated in RCT.
Obex combines different molecules with potential effects inducing weight loss and control on metabolic parameters such as fasting glucose, cholesterol and triglycerides.
Therefore, the administration of Obex in overweight and obese patients with impaired fasting glucose could be an excellent strategy to induce weight loss and ameliorate the metabolic disturbances related to obesity and overweight.

Conditions studied

Overweight
Obesity

Browse trials for

Keywords

Impaired fasting glucose
Prediabetes
Obesity
Overweight
Insulin sensitivity
Weight loss
Nutritional supplement
Waist
Body composition

In context

Obesity Reclassified

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's enrollment of 40 is below the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Catalysis SL is the lead sponsor of 53 studies on the registry; 4 are open to participants now.

Browse Catalysis SL studies →

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 →

Who can participate

Ages eligible: 20 Years to 60 Years
Sexes eligible: All
Accepts healthy volunteers: No

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.

Inclusion criteria

Overweight and Obese subjects with and without IFG
Ability to provide

Exclusion criteria

Exclusion Criteria:

Presence of diabetes mellitus, hepatic, renal or cardiovascular disease
Other diseases associated with insulin resistance (eg. Acromegalia, endogenous hypercortisolism, etc)
Sepsis or any other condition that could potentially interfere with treatment
History of bariatric surgery
Pregnancy or lactation
Concomitant disease with reduced
Severe psychiatric conditions
Anyone with chronic medical conditions requiring regular intake of any prescription medications.
Used drugs for weight loss (e.g., Xenical [orlistat], Meridia [sibutramine], Acutrim [phenylpropanolamine], Accomplia [rimonabant], Alli [low-dose orlistat], or other similar over-the-counter weight loss remedies or medications) within 3 months of screening
Are actively participating in, or have participated in a formal weight loss program within the last 3 months

Terms in these criteria, in plain language(2)

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.

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.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Study design

Phase: Phase 2 / Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 40 participants (actual)

Study arms

Experimental
Obex
Obex®, two oral sachets daily during three months.
Dietary Supplement: Obex

Interventions

Dietary supplementObex
Obex® will be administered two sachets daily dissolved in a glass of water, 30 minutes before lunch and dinner during three months. Participants will be not trained about changes of lifestyle on their diets, or physical activity.

What researchers measure

Primary outcomes

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
Time frame: Three months of treatment
To determine the safety of serious supplement-related adverse events
Adverse events will be evaluated during the three months of treatment
Time frame: Three months of treatment

Secondary outcomes

To evaluate the effect of Obex® on fasting insulin levels
The insulin levels will be evaluated at baseline and at the end of treatment.
Time frame: Three months of treatment
• To evaluate the effect of Obex® on insulin sensitivity by homeostasis model assessment-estimated insulin resistance (HOMA-IR), calculated from individual serum measures (fasting insulin x fasting glucose/22.5)
The HOMA-IR will be evaluated at baseline and at the end of treatment.
Time frame: Three months of treatment
To evaluate the effect of Obex® on insulin sensitivity by quantitative insulin sensitivity check index, Bennett and Raynaud insulin sensitivity indexes
The Quicki, Bennett and Raynaud insulin sensitivity indexes will be evaluated at baseline and at the end of treatment. QUICKI = \[1/\[log I0 + log G0\], Bennett index (BEN) = 1/(log I0 x log G0), Raynaud index (RAY) = \[40/I0\])
Time frame: Three months of treatment
• To evaluate the effect of Obex® on β-cell function by homeostatic model assessment-beta cell (HOMA-β), calculated from individual serum measures (20 x fasting insulin (µU/mL)/fasting glucose (mmol/L)-3.5)
The HOMA-B will be evaluated at baseline and at the end of treatment
Time frame: Three months of treatment
• To evaluate the effect of Obex® on cholesterol, triglyceride and high density lipoprotein cholesterol levels (HDL-c)
The cholesterol, triglyceride and HDL-c levels will be evaluated at baseline and at the end of treatment.
Time frame: Three months of treatment
To evaluate the effect of Obex® on Glycosylated Hemoglobin (HbA1c)
The HbA1c will be evaluated at baseline and at the end of treatment.
Time frame: Three months of treatment
To evaluate the effect of Obex® on the body weight.
The body weight will be measured at baseline and at the end of treatment.
Time frame: Three months of treatment
• To evaluate the effect of Obex® on Body Mass Index (BMI) and Conicity Index (CI)
The BMI and CI will be measured at baseline and at the end of treatment.
Time frame: Three months of treatment
To evaluate the effect of Obex® on the waist and hip circumferences
Waist and Hip circumferences will be measured at baseline and at the end of treatment.
Time frame: Three months of treatment
To evaluate the effect of Obex® on arterial blood pressures (BP)
The arterial BP will be evaluated at baseline and at the end of treatment.
Time frame: Three months of treatment
• To evaluate the effect of Obex® on hepatic enzymes (Alanine aminotransferase, Aspartate aminotransferase, gamma-glutamyltransferase, Alkaline Phosphatase)
The hepatic enzymes will be evaluated at baseline and at the end of treatment.
Time frame: Three months of treatment
To evaluate the effect of Obex® on creatinine and uric acid concentrations
The creatinine and uric acid levels will be evaluated at baseline and at the end of treatment.
Time frame: Three months of treatment
To evaluate the effect of Obex® on haemoglobin and serum iron levels
The haemoglobin and iron levels will be evaluated at baseline and at the end of treatment.
Time frame: Three months of treatment

Study locations

1 site

National Institute of Endocrinology
Plaza de la Revolución, Havana 10400, Cuba

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2014, a primary completion of Jul 2014 and a completion of Nov 2014. 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.

Registered: May 20, 2014
First posted: May 23, 2014
Start: Jun 2014
Primary completionActual: Jul 2014
CompletionActual: Nov 2014
Last update: May 8, 2018

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on May 8, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02145442
Lead sponsor: Catalysis SL
Responsible party: Sponsor
First posted: May 23, 2014
Start date: Jun 2014
Primary completion: Jul 2014
Completion: Nov 2014
Last update: May 8, 2018

Study contacts

Eduardo Cabrera, M.D., Ph.D.

principal investigator · National Institute of Endocrinology, Havana, Cuba

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions 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.

Other studies in this condition

Obesity →

Other studies from this sponsor

Catalysis SL →

Start the discussion