Clinical Trial of Safety and Efficacy of Various Dosage Schedules for Dietressa Drug in Treatment of Obese Patients

Study Overview
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Brief Summary
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The purpose of this study is: To assess safety of Dietressa in the dose of 6 tablets daily within 24 weeks in treatment of obese patients. To assess clinical efficacy of Dietressa in the dose of 6 tablets daily within 24 weeks of therapy in reducing body weight in obese patients. To compare clinical efficacy of two dosage patterns for Dietressa (1 tablet 6 times daily and 2 tablets 3 times daily) within 24 weeks in treatment of obese patients.

Detailed Description
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In general, patients will be observed during 24 weeks of trial.

Official Title
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Multicentric Double-blind Placebo-controlled Randomized Parallel-group Clinical Trial of Safety and Efficacy of Various Dosage Schedules for Dietressa Drug in Treatment of Obese Patients

Conditions
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Obesity

Intervention / Treatment
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* Drug: Dietressa
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Outpatient subjects with BMI 30,0-34,9 kg/m2. Male or female subjects aged 18 to 65 inclusive. Use of and compliance with contraception methods by patients of reproductive age, of both sexes. Presence of the patient's information sheet (informed consent form) for participation in the clinical trial. Exclusion Criteria: 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, namely, insulin, glucocorticosteroids, neuroleptics etc.). Compliance with a diet prescribed and monitored by the doctor to reduce body weight within 6 months before enrollment. Participation in the lifestyle modification program within 6 months before enrollment. 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. Uncontrolled arterial hypertension (patients with 1-3 degree AH, receiving no adequate antihypertensive therapy). Type 1 and 2 diabetes mellitus. Edema syndrome with various etiology (chronic cardiac failure, nephrotic syndrome, hepatic cirrhosis). Circulatory failure, IIА degree and above. Decompensated cardiovascular disease, liver, kidney or gastrointestinal tract disease, metabolic, respiratory, endocrine, hematologic disease, peripheral vessel disease or another medical state. Oncological disease. Diseases and states, which, in the investigator's opinion, may prevent the patient from participating in the trial. Past history of bulimia / non-drug abepithymia. Past history of any bariatric surgeries. Lipoplasty underwent less then 1 year prior to screening visit, or cavitary surgery less then 6 months prior to screening visit. Surgeries scheduled within 6 months. Allergy to/intolerance of any of the drug components used during treatment. Malabsorption syndrome, including congenial or acquired lactase or another disaccharidase insufficiency. Administration of drugs specified as Prohibited concomitant therapy, within 6 months before enrollment. Pregnancy, breast-feeding, unwillingness to comply with contraception methods during the trial and within 30 days after completion of participation in the trial. Drug and alcohol consumption (over 2 alc. units daily), mental diseases. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dietressa (2 tablets 3 times daily) for 24 weeks<br>Patients with Body Mass Index 30.0-34.9 (kg/m2) without previous anti-obesity treatment received Dietressa (2 tablets 3 times daily) for 24 weeks. | Drug: Dietressa<br>* Comparison of different dosages (frequency) of drug<br>|
| Experimental: Dietressa (1 tablet 6 times daily) for 24 weeks<br>Patients with Body Mass Index 30.0-34.9 (kg/m2) without previous anti-obesity treatment received Dietressa (1 tablet 6 times daily) for 24 weeks. | Drug: Dietressa<br>* Comparison of different dosages (frequency) of drug<br>|
| Placebo Comparator: Placebo (2 tablets 3 times daily)<br>Patients with Body Mass Index 30.0-34.9 (kg/m2) without previous anti-obesity treatment received Placebo (2 tablets 3 times daily) for 24 weeks. | Drug: Placebo<br>* Placebo either (2 tablets 3 times daily) or (1 tablet 6 times daily)<br>|
| Placebo Comparator: Placebo (1 tablet 6 times daily)<br>Patients with Body Mass Index 30.0-34.9 (kg/m2) without previous anti-obesity treatment received Placebo (1 tablet 6 times daily) for 24 weeks. | Drug: Placebo<br>* Placebo either (2 tablets 3 times daily) or (1 tablet 6 times daily)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects Who Lose at Least 5 Percent of Baseline Body Weight After 24 Weeks of Treatment Weeks of Treatment |  | assessed after 24 weeks of treatment | 
| Average Body Weight Change After 24 Weeks of Treatment |  | assessed after 24 weeks of treatment | 
| Average Relative Change in Body Weight After 24 Weeks of Treatment |  | assessed after 24 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects With a Decrease in Body Weight by 5 or More Percent of Baseline Body Weight After 4, 8, 12, 16, 20 and 24 Weeks of Treatment |  | assessed after 4, 8, 12, 16, 20, and 24 weeks of treatment | 
| Average Relative Weight Change After 4, 8, 12, 16, 20 and 24 Weeks of Treatment |  | assessed after 4, 8, 12, 16, 20 and 24 weeks of treatment | 
| Waist Hip Ratio After 4, 12 and 24 Weeks of Treatment |  | assessed after 4,12 and 24 weeks of treatment | 
| Change in the Quality of Life According to the Data of SF-36 Health Status Survey Questionnaire (SF-36) After 4, 12 and 24 Weeks of Treatment | 36 items of the questionnaire are grouped into eight subscales. The subscales are grouped in two scales: the physical component of health and mental health component. The scores of each scale range between 0 and 100: the higher the score, the better the quality of life and the better the patient's health. The instruction is not given completely because of the large volume. For more information, see: Ware J.E., Snow K.K., Kosinski M., Gandek B. SF-36 Health Survey. Manual and interpretation guide //The Health Institute, New England Medical Center. Boston, Mass.-1993. In this instruction is explained how eight subscales are combined to compute a total score. | baseline, 4, 12 and 24 weeks |