Obex® - Overweight and Obese - Adults - Phase III

Phase 3

• Conditions: Obesity; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Overweight; Body Weight

• Registration Number: RPCEC00000267
• Lead Sponsor: Catalysis, S.L. laboratory

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-17
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

1.Patients who fulfill the diagnosis criteria of overweight or obesity
2.Age between 20 and 65 years old.
3.Values of fasting glycemia <7.0 mmol / L and at two hours <11.1 mmol / L during PTG-O.
4.Written informed consent of participation in the study
5.BMI = 25.0 and less than 40

Exclusion Criteria

1. Thyroid dysfunction (hypo or hyperthyroidism).
2. Type 1 or type 2 diabetes.
3. Prediabetes treated with oral agents.
4. Alterations of lipids treated with drugs.
5. Medicine consumption of or dietary supplements that influence the reduction of body weight.
6. Consumption of steroids or prolonged use of them (last 3 months).
7. Treatment with immunosuppressive drugs.
8. Chronic diseases (of the hepatic, renal and cardiovascular systems, pancreatitis or some type of malignancy condition) or acute at the time of inclusion.
9. Insulin resistance due to diseases such as acromegaly, endogenous hypercortisolism, polycystic ovarian syndrome or hyperprolactinemia.
10. History of symptomatic hypoglycaemia
11. History of chronic debilitating diseases, anemia and collagen diseases.
11. History or existence psychological illness with eating disorders or toxicity.
12. History of alcoholism or drug dependence.
13. Inability to comply with the instructions of the investigation.
14. Severe infections at the time of inclusion.
15. Women of childbearing age who use hormonal contraceptives (oral or injectable).
16. Pregnant or breastfeeding.
17. Known sensitivity to any of the components of the formulation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Weight (Value in kg). Measurement time: At baseline, 3, 6, 9 and, 12 months.<br>Waist circumference (value in cm). Measurement time: At baseline, 3, 6, 9 and, 12 months.<br>