UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054277 |
|---|---|
| Receipt number | R000061771 |
| Scientific Title | 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. |
| Date of disclosure of the study information | 2024/05/01 |
| Last modified on | 2024/04/27 15:07:52 |
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Basic information
Public title
EFFICACY AND SAFETY OF TESOFENSINE FOR THE TREATMENT OF OBESITY IN ADULTS. A PHASE 3 RANDOMIZED CONTROLLED STUDY
Acronym
MEX-TESObesity
Scientific Title
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.
Scientific Title:Acronym
TESObesity
Region
| North America |
Condition
Condition
Obesity
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the weight-lowering efficacy and safety of 6-months treatment with 0.25 mg or 0.5 mg tesofensine compared to placebo in adult subjects with obesity.
Basic objectives2
Others
Basic objectives -Others
To evaluate changes in body composition and metabolic parameters in subjects with obesity treated with 0.25 mg or 0.5 mg tesofensine, compared to placebo
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase III
Assessment
Primary outcomes
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
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intervention - Tesofensine 0.25 mg
Interventions/Control_2
Intervention - Tesofensine 0.50 mg
Interventions/Control_3
Placebo
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key 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
Key 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
Target sample size
372
Research contact person
Name of lead principal investigator
| 1st name | Juan |
| Middle name | Gerardo |
| Last name | Reyes-Garcia |
Organization
Instituto Politecnico Nacional
Division name
Seccion de Estudios de Posgrado e Investigacion, Escuela Superior de Medicina.
Zip code
11340
Address
Salvador Diaz Miron esq. Plan de San Luis SN, Miguel Hidalgo, Casco de Santo Tomas, 11340 Ciudad de Mexico, CDMX
TEL
525557296300
jgreyesg@ipn.mx
Public contact
Name of contact person
| 1st name | Juan |
| Middle name | Gerardo |
| Last name | Reyes-Garcia |
Organization
Instituto Politecnico Nacional
Division name
Seccion de Estudios de Posgrado e Investigacion, Escuela Superior de Medicina
Zip code
11340
Address
Salvador Diaz Miron esq. Plan de San Luis SN, Miguel Hidalgo, Casco de Santo Tomas, 11340
TEL
525557296300
Homepage URL
https://www.sepi.esm.ipn.mx/
jgreyesg@ipn.mx
Sponsor or person
Institute
Instituto Politecnico Nacional
Institute
Department
Personal name
Funding Source
Organization
Productos Medix, S.A. de C.V.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Instituto Nacional de Enfermedades Respiratorias
Address
Calz. de Tlalpan 4502, Belisario Dominguez Secc 16, Tlalpan, 14080 Ciudad de Mexico, CDMX
Tel
+52 5554871728
nayeli@iner.gob.mx
Secondary IDs
Secondary IDs
YES
Study ID_1
1637/E/MDX
Org. issuing International ID_1
Mexican registry of the Comision Federal para la Proteccion contra Riesgos Sanitarios (COFEPRIS)
Study ID_2
C12-17
Org. issuing International ID_2
Research and Ethics Committee of the Instituto Nacional de Enfermedades Respiratorias (INER/CEI/053/17)
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
https://siipris03.cofepris.gob.mx/Resoluciones/Consultas/ConWebRegEnsayosClinicosDetalle.asp?idsolic
Publication of results
Published
Result
URL related to results and publications
https://siipris03.cofepris.gob.mx/Resoluciones/Consultas/ConWebRegEnsayosClinicosDetalle.asp?idsolic
Number of participants that the trial has enrolled
372
Results
For the primary efficacy outcome of absolute weight reduction after 24 weeks, both groups receiving tesofensine had greater weight loss than placebo (Placebo: 1.9 (SE: 0.3) kg; 0.25 mg tesofensine: 5.3 (SE: 0.4) kg, and 0.50 mg tesofensine: 8.6 (SE: 0.5) kg).
Results date posted
| 2024 | Year | 04 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The mean age of the sample was 40.8 (SD:10.2) years and there was a greater participation of women than men (85.2% vs. 14.8%). Baseline anthropometric, clinical, and metabolic parameters were similar in the three study groups, as well as comparable variability of data.
Participant flow
Out of 411 Mexican subjects assessed for this study, 372 were randomized after corroborating fulfillment of all eligibility criteria. Recruitment was balanced among the two centers with 188 (50.5%) from AMIC and 184 (49.5%) from INER. Most subjects completed the 24-week follow-up period (77.4%, n=288). Of 84 subjects who discontinued treatment, 14.3% (n=12) were attributable to an adverse event.
Adverse events
Out of all subjects, a total of 242 (65.1%) experienced at least one adverse event (AE). The proportion of participants experiencing an AE across study groups was similar. There was a total of 1198 AE throughout the study including follow-up, of which 2 were severe (tendinous rupture in one patient receiving 0.5 mg tesofensine, and cholecystitis in a patient treated with 0.25 mg tesofensine); both were classified as unlikely related to the treatment.
Outcome measures
For the primary efficacy outcome of absolute weight reduction after 24 weeks, both groups receiving tesofensine had greater weight loss than placebo (Placebo: 1.9 (SE: 0.3) kg; 0.25 mg tesofensine: 5.3 (SE: 0.4) kg, and 0.50 mg tesofensine: 8.6 (SE: 0.5) kg).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 08 | Month | 29 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 08 | Day |
Last follow-up date
| 2018 | Year | 01 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 04 | Month | 28 | Day |
Last modified on
| 2024 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061771
