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

Clinical study to evaluate the efficacy and safety of Tesofensine on body weight loss and body composition of Mexican patients with obesity. Double-blind, randomized, placebo-controlled, multicenter clinical trial. - TESObesity

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000054277

Enrollment

372

Registered

2024-05-01

Start date

2017-08-08

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Interventions

Intervention - Tesofensine 0.25 mg Intervention - Tesofensine 0.50 mg Placebo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Men and women with ages between 18 to 65 years 2. A body mass index (BMI) greater than or equal to 30 and lower than 50 3. Agreed to participate in the study and provided their written informed consent. 4. Women of childbearing age who declared using a contraceptive method

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

North America

Contacts

Public ContactJuan Reyes-Garcia

Instituto Politecnico Nacional Seccion de Estudios de Posgrado e Investigacion, Escuela Superior de Medicina

jgreyesg@ipn.mx525557296300

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026