EFFICACY AND SAFETY OF TESOFENSINE FOR THE TREATMENT OF OBESITY IN ADULTS. A PHASE 3 RANDOMIZED CONTROLLED STUDY

UMIN ID: UMIN000054277

Registered date:01/05/2024

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Obesity
• Date of first enrollment: 2017/08/08
• Target sample size: 372
• Countries of recruitment: North America
• Study type: Interventional

Intervention(s)

Intervention - Tesofensine 0.25 mg
Intervention - Tesofensine 0.50 mg
Placebo

Outcome(s)

• Primary Outcome: 1. Mean change in absolute and percentage body weight after 24 weeks of treatment 2. Proportion of drug-related adverse events after 24 weeks of treatment
• Secondary Outcome: 1. Proportion of subjects who reached a body weight percentage equal or higher than 5 and 10 percentage after 12 and 24 weeks of treatment. 2. Absolute difference between baseline and week 24 in body mass index 3. Absolute difference between baseline and week 24 in waist circumference 4. Absolute difference between baseline and week 24 in waist-to-hip ratio 5. Absolute difference between baseline and week 24 in body fat percentage 6. Absolute difference between baseline and week 24 in muscle mass percentage 7. Absolute difference between baseline and week 24 in fasting plasma glucose 8. Absolute difference between baseline and week 24 in serum triglycerides 9. Absolute difference between baseline and week 24 in total cholesterol 10. Absolute difference between baseline and week 24 in high-density lipoprotein-cholesterol 11. Absolute difference between baseline and week 24 in low-density lipoprotein-cholesterol 12. Absolute difference between baseline and week 24 in very low-density lipoprotein-cholesterol 13. Absolute difference between baseline and week 24 in atherogenic index 14. Absolute difference between baseline and week 24 in glycated hemoglobin (HbA1c) 15. Absolute difference between baseline and week 24 in insulin 16. Absolute difference between baseline and week 24 in and homeostatic model assessment for insulin resistance (HOMA-IR). 17. Absolute difference between baseline and week 24 in temperature 18. Absolute difference between baseline and week 24 in cardiac rate 19. Absolute difference between baseline and week 24 in respiratory rate 20. Absolute difference between baseline and week 24 in and blood pressure

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude criteria: 1. Pregnant or lactating women 2. Hypersensitivity to tesofensine 3. Treatment with special diets (vegan or ketogenic) 4. Prior pharmacological or surgical treatment against obesity, 5. Presence of chronic metabolic diseases or another diseases as: a) Uncontrolled type 2 diabetes (without regular treatment with metformin or lifestyle modifications) b) Uncontrolled systemic arterial hypertension c) Psychiatric illnesses d) Thyroid disease e) Cardiovascular diseases f) Gastrointestinal malabsorptive disease g) Cancer h) Ophthalmologic disease i) Electrocardiographic abnormalities j) History of hypotension

Related Information

• Primary Sponsor: Instituto Politecnico Nacional
• Source(s) of Monetary Support: Productos Medix, S.A. de C.V.
• Secondary ID(s): 1637/E/MDX,C12-17