Unknown statusInterventionalNot ApplicableUpdated Oct 22, 2013
Effects of Obex in Overweight and Obese Patients | NCT02145442 | Trialant
CompletedInterventionalPhase 2Phase 3Updated May 8, 2018
Effects of Obex in Overweight and Obese Patients
Effects and Safety of Obex in Overweight and Obese Subjects With or Without Impaired Fasting Glucose
ClinicalTrials.gov ID
NCT02145442
Lead Sponsor
Catalysis SLINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 2Phase 3
Enrollment
40Actual
Last Update Posted
May 8, 2018Actual
Start Date
Jun 2014
Primary Completion Date
Jul 2014Actual
Completion Date
Nov 2014Actual
Official Title
Effects and Safety of Obex in Overweight and Obese Subjects With or Without Impaired Fasting Glucose
Brief 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.
Overweight
Obesity
Obex
Ages Eligible for Study
Adult (18-64)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Overweight and Obese subjects with and without IFG
Ability to provide informed consent
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 life expectancy
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