Obesity
Conditions
Brief summary
* To assess safety of Dietressa in the dose of 6 tablets daily within 24 weeks in treatment of obese patients (BMI 35,0-39,9 kg/m2). * To assess clinical efficacy of Dietressa in the dose of 6 tablets daily after 24 weeks of therapy in reducing body weight in obese patients (BMI 35,0-39,9 kg/m2).
Detailed description
In general, patients will be observed during 24 weeks of trial.
Interventions
DRUGDietressa
Oral administration.
DRUGPlacebo
Oral administration.
Sponsors
Materia Medica Holding
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Outpatient subjects with BMI 35,0-39,9 kg/m2. 2. Males or females aged from 18 to 65 years. 3. Use of and compliance with contraception methods by patients of reproductive age, of both sexes. 4. Presence of the patient's information sheet (informed consent form) for participation in the clinical trial.
Exclusion criteria
1. Symptomatic (secondary) obesity: * with established genetic defect (including as a part of known genetic syndromes affecting multiple organs): Prader-Willi syndrome, Alstrom's syndrome, Laurence-Moon-Biedl syndrome, Dercum's syndrome etc. * cerebral (adiposogenital dystrophy, Babinski-Frohlich syndrome): brain tumors; dissemination of systemic lesions, infectious diseases; against mental diseases. * endocrine: hypothyroid; hypoovarial; pituitary-hypothalamic disorders; adrenopathy. * iatrogenic (caused by drug administration, for example, insulin, glucocorticosteroids, neuroleptics etc.). 2. Compliance with a diet prescribed and monitored by the doctor to reduce body weight within 6 months before enrollment. 3. Participation in the lifestyle modification program within 6 months before enrollment. 4. Patients who quit smoking within 6 months before enrollment, or intending to quit smoking during the period of participation in the trial, as well as intending to begin smoking during the trial. 5. Uncontrolled arterial hypertension (patients with 1-3 degree AH, receiving no adequate antihypertensive therapy). 6. Type 1 and 2 diabetes mellitus. 7. Edema syndrome with various etiology (chronic cardiac failure, nephrotic syndrome, hepatic cirrhosis). 8. Circulatory failure, IIА degree and above. 9. Decompensated cardiovascular disease, liver, kidney or gastrointestinal tract disease, metabolic, respiratory, endocrine, hematologic disease, peripheral vessel disease or another medical state. Oncological disease. 10. Diseases and states, which, in the investigator's opinion, may prevent the patient from participating in the trial. 11. Past history of bulimia / non-drug anorexia. 12. Past history of any bariatric surgeries. 13. Lipoplasty underwent less then 1 year prior to screening visit, or cavitary surgery less then 6 months prior to screening visit. 14. Surgeries scheduled within 6 months. 15. Allergy to/intolerance of any of the drug components used during treatment. 16. Malabsorption syndrome, including congenial or acquired lactase or another disaccharidase insufficiency. 17. Administration of drugs specified as Prohibited concomitant therapy, within 6 months before enrollment. 18. Pregnancy, breast-feeding, unwillingness to comply with contraception methods during the trial and within 30 days after completion of participation in the trial. 19. Drug and alcohol consumption (over 2 alc. units daily), mental diseases. 20. Legal incapacity or limited legal capacity. 21. Patients, who, in the investigator's opinion, will fail to observe the requirements during the trial or adhere to the studied drug administration procedure. 22. Participation in other clinical trials within 3 months before enrolment in this trial. 23. Presence of other factors, complicating the patient's participation in the trial (e.g., planned lengthy business and other trips). 24. A patient is a part of the center's research staff, taking a direct part in the trial, or an immediate family member of the investigator. Immediate family members are defined as spouses, parents, children or siblings, regardless of whether full blood or adopted. 25. The patient is employed with Scientific Production Firm Materia Medica Holding LLC, i.e. is the company's employee, part-time employee under contract, or appointed official in charge of the trial, or their immediate family.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With at Least 5% Weight Loss. | 24 weeks | Based on medical records. |
| Average Absolute Weight Change | On baseline and after 24 weeks | Based on medical records. |
| Average Relative Weight Change | On baseline and after 24 weeks | Based on medical records. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Waist Circumference, Waist Circumference/Hip Circumference. | After 4, 12 and 24 weeks of treatment | Based on medical records. |
| Percentage of Patients With at Least 5% Weight Loss. | On baseline and after 4, 8, 12, 16, 20, 24 weeks of treatment | Based on medical records. |
| Dynamics of the Quality of Life According to the SF-36 Questionnaire. | On baseline and after 4, 12, 24 weeks of treatment | Based on medical records. The short version of the SF-36 quality of life questionnaire is completed at visits 1, 2, 4, 7. The SF-36 questionnaire form consists of 11 sections, in each of which it is required to circle one number on each line. The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical activity score of the SF-36. Items 5-8 primarily contribute to the mental health score of the SF-36. Scores on each item are summed and averaged (range: 0=worst to 100=best). Increases from baseline indicate improvement. The 'overall' estimate is the average change from baseline |
| Average Absolute Weight Change | After 4, 8, 12, 16 and 20 weeks of treatment | Based on medical records. |
| Average Relative Weight Change | After 4, 8, 12, 16 and 20 weeks of treatment | Based on medical records. |
Countries
Russia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dietressa Tablet for oral use. 1 tablet 6 times a day. The duration of Dietressa therapy is 24 weeks.
Dietressa: Oral administration. | 164 |
| Placebo Tablet for oral use. 1 tablet 6 times a day. The duration of Placebo therapy is 24 weeks.
Placebo: Oral administration. | 167 |
| Total | 331 |
Baseline characteristics
| Characteristic | Placebo | Total | Dietressa |
|---|---|---|---|
| Age, Continuous | 42.8 years STANDARD_DEVIATION 11.6 | 43.2 years STANDARD_DEVIATION 11.5 | 43.7 years STANDARD_DEVIATION 11.4 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Russia | 167 participants | 331 participants | 164 participants |
| Sex: Female, Male Female | 139 Participants | 277 Participants | 138 Participants |
| Sex: Female, Male Male | 28 Participants | 54 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 164 | 0 / 167 |
| other Total, other adverse events | 76 / 164 | 64 / 167 |
| serious Total, serious adverse events | 2 / 164 | 3 / 167 |
Outcome results
Primary
Average Absolute Weight Change
Based on medical records.
Time frame: On baseline and after 24 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dietressa | Average Absolute Weight Change | Baseline | 104.7 kilogram | Standard Deviation 11.6 |
| Dietressa | Average Absolute Weight Change | After 24 weeks | 98.6 kilogram | Standard Deviation 12.7 |
| Dietressa | Average Absolute Weight Change | ∆ between baseline and after 24 weeks | 6.1 kilogram | Standard Deviation 5.3 |
| Placebo | Average Absolute Weight Change | Baseline | 105.3 kilogram | Standard Deviation 11.4 |
| Placebo | Average Absolute Weight Change | After 24 weeks | 101.3 kilogram | Standard Deviation 12.1 |
| Placebo | Average Absolute Weight Change | ∆ between baseline and after 24 weeks | 4.0 kilogram | Standard Deviation 4.6 |
p-value: 0.0001Wilcoxon (Mann-Whitney)
Primary
Average Relative Weight Change
Based on medical records.
Time frame: On baseline and after 24 weeks
Population: ∆ between baseline and after 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dietressa | Average Relative Weight Change | 5.9 percentage of weight loss from baseline | Standard Deviation 5.1 |
| Placebo | Average Relative Weight Change | 3.8 percentage of weight loss from baseline | Standard Deviation 4.4 |
p-value: 0.0001Wilcoxon (Mann-Whitney)
Primary
Percentage of Patients With at Least 5% Weight Loss.
Based on medical records.
Time frame: 24 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dietressa | Percentage of Patients With at Least 5% Weight Loss. | 80 Participants |
| Placebo | Percentage of Patients With at Least 5% Weight Loss. | 62 Participants |
p-value: 0.0352Fisher Exact
Secondary
Average Absolute Weight Change
Based on medical records.
Time frame: After 4, 8, 12, 16 and 20 weeks of treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dietressa | Average Absolute Weight Change | Average absolute weight reduction after 8 weeks | 2.9 kilogram | Standard Deviation 3.1 |
| Dietressa | Average Absolute Weight Change | Average absolute weight reduction after 16 weeks | 4.7 kilogram | Standard Deviation 4.6 |
| Dietressa | Average Absolute Weight Change | Average absolute weight reduction after 12 weeks | 3.8 kilogram | Standard Deviation 3.9 |
| Dietressa | Average Absolute Weight Change | Average absolute weight reduction after 20 weeks | 5.5 kilogram | Standard Deviation 4.9 |
| Dietressa | Average Absolute Weight Change | Average absolute weight reduction after 4 weeks | 1.8 kilogram | Standard Deviation 2.2 |
| Placebo | Average Absolute Weight Change | Average absolute weight reduction after 20 weeks | 3.7 kilogram | Standard Deviation 4.1 |
| Placebo | Average Absolute Weight Change | Average absolute weight reduction after 4 weeks | 1.3 kilogram | Standard Deviation 1.8 |
| Placebo | Average Absolute Weight Change | Average absolute weight reduction after 8 weeks | 2.1 kilogram | Standard Deviation 2.6 |
| Placebo | Average Absolute Weight Change | Average absolute weight reduction after 12 weeks | 2.8 kilogram | Standard Deviation 3.2 |
| Placebo | Average Absolute Weight Change | Average absolute weight reduction after 16 weeks | 3.3 kilogram | Standard Deviation 3.7 |
p-value: 0.0004ANOVA
Secondary
Average Relative Weight Change
Based on medical records.
Time frame: After 4, 8, 12, 16 and 20 weeks of treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dietressa | Average Relative Weight Change | Average relative weight reduction after 8 weeks | 2.8 percentage of weight loss from baseline | Standard Deviation 2.9 |
| Dietressa | Average Relative Weight Change | Average relative weight reduction after 16 weeks | 4.5 percentage of weight loss from baseline | Standard Deviation 4.4 |
| Dietressa | Average Relative Weight Change | Average relative weight reduction after 12 weeks | 3.7 percentage of weight loss from baseline | Standard Deviation 3.7 |
| Dietressa | Average Relative Weight Change | Average relative weight reduction after 20 weeks | 5.3 percentage of weight loss from baseline | Standard Deviation 4.8 |
| Dietressa | Average Relative Weight Change | Average relative weight reduction after 4 weeks | 1.7 percentage of weight loss from baseline | Standard Deviation 2.1 |
| Placebo | Average Relative Weight Change | Average relative weight reduction after 20 weeks | 3.5 percentage of weight loss from baseline | Standard Deviation 4 |
| Placebo | Average Relative Weight Change | Average relative weight reduction after 4 weeks | 1.3 percentage of weight loss from baseline | Standard Deviation 1.7 |
| Placebo | Average Relative Weight Change | Average relative weight reduction after 8 weeks | 2.0 percentage of weight loss from baseline | Standard Deviation 2.5 |
| Placebo | Average Relative Weight Change | Average relative weight reduction after 12 weeks | 2.7 percentage of weight loss from baseline | Standard Deviation 3 |
| Placebo | Average Relative Weight Change | Average relative weight reduction after 16 weeks | 3.2 percentage of weight loss from baseline | Standard Deviation 3.5 |
p-value: 0.0004ANOVA
Secondary
Change in Waist Circumference, Waist Circumference/Hip Circumference.
Based on medical records.
Time frame: After 4, 12 and 24 weeks of treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dietressa | Change in Waist Circumference, Waist Circumference/Hip Circumference. | Change in waist circumference after 4 weeks | 2.2 centimeter | Standard Deviation 3.3 |
| Dietressa | Change in Waist Circumference, Waist Circumference/Hip Circumference. | Change in waist circumference after 12 weeks | 4.8 centimeter | Standard Deviation 5.2 |
| Dietressa | Change in Waist Circumference, Waist Circumference/Hip Circumference. | Change in waist circumference after 24 weeks | 6.9 centimeter | Standard Deviation 10.7 |
| Dietressa | Change in Waist Circumference, Waist Circumference/Hip Circumference. | Change in waist circumference/hip circumference after 4 weeks | 0.01 centimeter | Standard Deviation 0.03 |
| Dietressa | Change in Waist Circumference, Waist Circumference/Hip Circumference. | Change in waist circumference/hip circumference after 12 weeks | 0.01 centimeter | Standard Deviation 0.04 |
| Dietressa | Change in Waist Circumference, Waist Circumference/Hip Circumference. | Change in waist circumference/hip circumference after 24 weeks | 0.01 centimeter | Standard Deviation 0.04 |
| Placebo | Change in Waist Circumference, Waist Circumference/Hip Circumference. | Change in waist circumference/hip circumference after 12 weeks | 0.01 centimeter | Standard Deviation 0.05 |
| Placebo | Change in Waist Circumference, Waist Circumference/Hip Circumference. | Change in waist circumference after 4 weeks | 2.6 centimeter | Standard Deviation 3.5 |
| Placebo | Change in Waist Circumference, Waist Circumference/Hip Circumference. | Change in waist circumference/hip circumference after 4 weeks | 0.01 centimeter | Standard Deviation 0.03 |
| Placebo | Change in Waist Circumference, Waist Circumference/Hip Circumference. | Change in waist circumference after 12 weeks | 4.7 centimeter | Standard Deviation 5.4 |
| Placebo | Change in Waist Circumference, Waist Circumference/Hip Circumference. | Change in waist circumference/hip circumference after 24 weeks | 0.01 centimeter | Standard Deviation 0.04 |
| Placebo | Change in Waist Circumference, Waist Circumference/Hip Circumference. | Change in waist circumference after 24 weeks | 6.9 centimeter | Standard Deviation 6.1 |
Comparison: This analysis applies to rows with waist circumference data.p-value: 0.67ANOVA
Comparison: This analysis applies to rows with hip circumference data.p-value: 0.26ANOVA
Secondary
Dynamics of the Quality of Life According to the SF-36 Questionnaire.
Based on medical records. The short version of the SF-36 quality of life questionnaire is completed at visits 1, 2, 4, 7. The SF-36 questionnaire form consists of 11 sections, in each of which it is required to circle one number on each line. The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical activity score of the SF-36. Items 5-8 primarily contribute to the mental health score of the SF-36. Scores on each item are summed and averaged (range: 0=worst to 100=best). Increases from baseline indicate improvement. The 'overall' estimate is the average change from baseline
Time frame: On baseline and after 4, 12, 24 weeks of treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dietressa | Dynamics of the Quality of Life According to the SF-36 Questionnaire. | Baseline Physical Health domain | 46.6 score on a scale | Standard Deviation 8.1 |
| Dietressa | Dynamics of the Quality of Life According to the SF-36 Questionnaire. | After 4 weeks Physical Health domain | 47.7 score on a scale | Standard Deviation 7.8 |
| Dietressa | Dynamics of the Quality of Life According to the SF-36 Questionnaire. | After 12 weeks Physical Health domain | 49.1 score on a scale | Standard Deviation 7.6 |
| Dietressa | Dynamics of the Quality of Life According to the SF-36 Questionnaire. | After 24 weeks Physical Health domain | 49.7 score on a scale | Standard Deviation 6.8 |
| Dietressa | Dynamics of the Quality of Life According to the SF-36 Questionnaire. | Baseline Mental Health domain | 44.7 score on a scale | Standard Deviation 10.8 |
| Dietressa | Dynamics of the Quality of Life According to the SF-36 Questionnaire. | After 4 weeks Mental Health domain | 48.2 score on a scale | Standard Deviation 9.9 |
| Dietressa | Dynamics of the Quality of Life According to the SF-36 Questionnaire. | After 12 weeks Mental Health domain | 48.3 score on a scale | Standard Deviation 9.4 |
| Dietressa | Dynamics of the Quality of Life According to the SF-36 Questionnaire. | After 24 weeks Mental Health domain | 49.2 score on a scale | Standard Deviation 8.4 |
| Placebo | Dynamics of the Quality of Life According to the SF-36 Questionnaire. | After 24 weeks Mental Health domain | 50.4 score on a scale | Standard Deviation 8.3 |
| Placebo | Dynamics of the Quality of Life According to the SF-36 Questionnaire. | Baseline Physical Health domain | 47.3 score on a scale | Standard Deviation 8.4 |
| Placebo | Dynamics of the Quality of Life According to the SF-36 Questionnaire. | Baseline Mental Health domain | 46.3 score on a scale | Standard Deviation 9.7 |
| Placebo | Dynamics of the Quality of Life According to the SF-36 Questionnaire. | After 4 weeks Physical Health domain | 49.0 score on a scale | Standard Deviation 8 |
| Placebo | Dynamics of the Quality of Life According to the SF-36 Questionnaire. | After 12 weeks Mental Health domain | 49.2 score on a scale | Standard Deviation 8.9 |
| Placebo | Dynamics of the Quality of Life According to the SF-36 Questionnaire. | After 12 weeks Physical Health domain | 49.7 score on a scale | Standard Deviation 7.7 |
| Placebo | Dynamics of the Quality of Life According to the SF-36 Questionnaire. | After 4 weeks Mental Health domain | 48.5 score on a scale | Standard Deviation 9.3 |
| Placebo | Dynamics of the Quality of Life According to the SF-36 Questionnaire. | After 24 weeks Physical Health domain | 50.9 score on a scale | Standard Deviation 7.1 |
Comparison: This analysis applies to rows with Physical Health domain data.p-value: 0.4ANOVA
Comparison: This analysis applies to rows with Mental Health domain data.p-value: 0.34ANOVA
Secondary
Percentage of Patients With at Least 5% Weight Loss.
Based on medical records.
Time frame: On baseline and after 4, 8, 12, 16, 20, 24 weeks of treatment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dietressa | Percentage of Patients With at Least 5% Weight Loss. | After 4 weeks | 11 Participants |
| Dietressa | Percentage of Patients With at Least 5% Weight Loss. | After 16 weeks | 59 Participants |
| Dietressa | Percentage of Patients With at Least 5% Weight Loss. | After 8 weeks | 29 Participants |
| Dietressa | Percentage of Patients With at Least 5% Weight Loss. | After 20 weeks | 73 Participants |
| Dietressa | Percentage of Patients With at Least 5% Weight Loss. | Baseline | 0 Participants |
| Dietressa | Percentage of Patients With at Least 5% Weight Loss. | After 24 weeks | 80 Participants |
| Dietressa | Percentage of Patients With at Least 5% Weight Loss. | After 12 weeks | 49 Participants |
| Placebo | Percentage of Patients With at Least 5% Weight Loss. | After 24 weeks | 62 Participants |
| Placebo | Percentage of Patients With at Least 5% Weight Loss. | After 4 weeks | 5 Participants |
| Placebo | Percentage of Patients With at Least 5% Weight Loss. | After 8 weeks | 19 Participants |
| Placebo | Percentage of Patients With at Least 5% Weight Loss. | After 12 weeks | 32 Participants |
| Placebo | Percentage of Patients With at Least 5% Weight Loss. | After 16 weeks | 42 Participants |
| Placebo | Percentage of Patients With at Least 5% Weight Loss. | After 20 weeks | 49 Participants |
| Placebo | Percentage of Patients With at Least 5% Weight Loss. | Baseline | 0 Participants |
p-value: 0.0001Cochran-Mantel-Haenszel