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CompletedNCT01570829Updated Aug 26, 2021Results posted

Clinical Trial of Safety and Efficacy of New Dosage Schedule for Dietressa Drug in Treatment of Obese Patients

A Phase 3 interventional study of Dietressa and Placebo in Obesity, sponsored by Materia Medica Holding. Completed at 17 sites in Russian Federation. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-08-26.

Sponsored by Materia Medica Holding · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
331
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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).
Read the detailed description

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

02

Conditions studied

  • Obesity
03

In context

Lead sponsor

Materia Medica Holding is the lead sponsor of 42 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
331 participants (actual)

Study arms

  • Experimental
    Dietressa

    Tablet for oral use. 1 tablet 6 times a day. The duration of Dietressa therapy is 24 weeks.

    Drug: Dietressa

  • Placebo comparator
    Placebo

    Tablet for oral use. 1 tablet 6 times a day. The duration of Placebo therapy is 24 weeks.

    Drug: Placebo

Interventions

  • DrugDietressa

    Oral administration.

  • DrugPlacebo

    Oral administration.

06

What researchers measure

Primary outcomes

  1. Percentage of Patients With at Least 5% Weight Loss.

    Based on medical records.

    Time frame: 24 weeks

  2. Average Absolute Weight Change

    Based on medical records.

    Time frame: On baseline and after 24 weeks

  3. Average Relative Weight Change

    Based on medical records.

    Time frame: On baseline and after 24 weeks

Secondary outcomes

  1. 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

  2. Average Absolute Weight Change

    Based on medical records.

    Time frame: After 4, 8, 12, 16 and 20 weeks of treatment

  3. Average Relative Weight Change

    Based on medical records.

    Time frame: After 4, 8, 12, 16 and 20 weeks of treatment

  4. Change in Waist Circumference, Waist Circumference/Hip Circumference.

    Based on medical records.

    Time frame: After 4, 12 and 24 weeks of treatment

  5. 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

07

Results

Posted Aug 26, 2021

Participant flow

Participant flow — Overall Study
MilestoneDietressaPlacebo
Started164167
Completed164167
Not completed00

Outcome measures

PrimaryPercentage of Patients With at Least 5% Weight Loss.

Based on medical records.

Time frame:
24 weeks
Reported as:
Count of participants · Participants
Percentage of Patients With at Least 5% Weight Loss.
ParticipantsDietressaPlacebo
Percentage of Patients With at Least 5% Weight Loss.8062
Statistical analysis
  • Dietressa vs Placebo · Fisher Exact · p = 0.0352
PrimaryAverage Absolute Weight Change

Based on medical records.

Time frame:
On baseline and after 24 weeks
Reported as:
Mean · kilogram
Average Absolute Weight Change
kilogramDietressaPlacebo
Baseline104.7 ± 11.6105.3 ± 11.4
After 24 weeks98.6 ± 12.7101.3 ± 12.1
∆ between baseline and after 24 weeks6.1 ± 5.34.0 ± 4.6
Statistical analysis
  • Dietressa vs Placebo · Wilcoxon (Mann-Whitney) · p = 0.0001
PrimaryAverage Relative Weight Change

Based on medical records.

Time frame:
On baseline and after 24 weeks
Reported as:
Mean · percentage of weight loss from baseline
Average Relative Weight Change
percentage of weight loss from baselineDietressaPlacebo
Average Relative Weight Change5.9 ± 5.13.8 ± 4.4
Statistical analysis
  • Dietressa vs Placebo · Wilcoxon (Mann-Whitney) · p = 0.0001
SecondaryPercentage 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
Reported as:
Count of participants · Participants
Percentage of Patients With at Least 5% Weight Loss.
ParticipantsDietressaPlacebo
Baseline00
After 4 weeks115
After 8 weeks2919
After 12 weeks4932
After 16 weeks5942
After 20 weeks7349
After 24 weeks8062
Statistical analysis
  • Dietressa vs Placebo · Cochran-Mantel-Haenszel · p = 0.0001Breslow-Day test p-value is 0.98
SecondaryAverage Absolute Weight Change

Based on medical records.

Time frame:
After 4, 8, 12, 16 and 20 weeks of treatment
Reported as:
Mean · kilogram
Average Absolute Weight Change
kilogramDietressaPlacebo
Average absolute weight reduction after 4 weeks1.8 ± 2.21.3 ± 1.8
Average absolute weight reduction after 8 weeks2.9 ± 3.12.1 ± 2.6
Average absolute weight reduction after 12 weeks3.8 ± 3.92.8 ± 3.2
Average absolute weight reduction after 16 weeks4.7 ± 4.63.3 ± 3.7
Average absolute weight reduction after 20 weeks5.5 ± 4.93.7 ± 4.1
Statistical analysis
  • Dietressa vs Placebo · ANOVA · p = 0.0004 (The p-value associated with "treatment\*visit" interaction of changes from baseline to Week 4, 8, 12, 16 and 20 endpoint between Dietressa and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction.)
SecondaryAverage Relative Weight Change

Based on medical records.

Time frame:
After 4, 8, 12, 16 and 20 weeks of treatment
Reported as:
Mean · percentage of weight loss from baseline
Average Relative Weight Change
percentage of weight loss from baselineDietressaPlacebo
Average relative weight reduction after 4 weeks1.7 ± 2.11.3 ± 1.7
Average relative weight reduction after 8 weeks2.8 ± 2.92.0 ± 2.5
Average relative weight reduction after 12 weeks3.7 ± 3.72.7 ± 3.0
Average relative weight reduction after 16 weeks4.5 ± 4.43.2 ± 3.5
Average relative weight reduction after 20 weeks5.3 ± 4.83.5 ± 4.0
Statistical analysis
  • Dietressa vs Placebo · ANOVA · p = 0.0004 (The p-value associated with "treatment\*visit" interaction of changes from baseline to Week 4, 8, 12, 16 and 20 endpoint between Dietressa and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction.)
SecondaryChange in Waist Circumference, Waist Circumference/Hip Circumference.

Based on medical records.

Time frame:
After 4, 12 and 24 weeks of treatment
Reported as:
Mean · centimeter
Change in Waist Circumference, Waist Circumference/Hip Circumference.
centimeterDietressaPlacebo
Change in waist circumference after 4 weeks2.2 ± 3.32.6 ± 3.5
Change in waist circumference after 12 weeks4.8 ± 5.24.7 ± 5.4
Change in waist circumference after 24 weeks6.9 ± 10.76.9 ± 6.1
Change in waist circumference/hip circumference after 4 weeks0.01 ± 0.030.01 ± 0.03
Change in waist circumference/hip circumference after 12 weeks0.01 ± 0.040.01 ± 0.05
Change in waist circumference/hip circumference after 24 weeks0.01 ± 0.040.01 ± 0.04
Statistical analysis
  • Dietressa vs Placebo · ANOVA · p = 0.67 (The p-value associated with "treatment\*visit" interaction of changes from baseline to Week 4, 12, and 24 endpoint between Dietressa and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction.)
  • Dietressa vs Placebo · ANOVA · p = 0.26 (The p-value associated with "treatment\*visit" interaction of changes from baseline to Week 4, 12, and 24 endpoint between Dietressa and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction.)
SecondaryDynamics 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
Reported as:
Mean · score on a scale
Dynamics of the Quality of Life According to the SF-36 Questionnaire.
score on a scaleDietressaPlacebo
Baseline Physical Health domain46.6 ± 8.147.3 ± 8.4
After 4 weeks Physical Health domain47.7 ± 7.849.0 ± 8.0
After 12 weeks Physical Health domain49.1 ± 7.649.7 ± 7.7
After 24 weeks Physical Health domain49.7 ± 6.850.9 ± 7.1
Baseline Mental Health domain44.7 ± 10.846.3 ± 9.7
After 4 weeks Mental Health domain48.2 ± 9.948.5 ± 9.3
After 12 weeks Mental Health domain48.3 ± 9.449.2 ± 8.9
After 24 weeks Mental Health domain49.2 ± 8.450.4 ± 8.3
Statistical analysis
  • Dietressa vs Placebo · ANOVA · p = 0.40 (The p-value associated with "treatment\*visit" interaction of changes from baseline to Week 4, 12, and 24 endpoint between Dietressa and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction.)
  • Dietressa vs Placebo · ANOVA · p = 0.34 (The p-value associated with "treatment\*visit" interaction of changes from baseline to Week 4, 12, and 24 endpoint between Dietressa and Placebo treatment groups. Model includes treatment, visit and treatment\*visit interaction.)

Adverse events

Collected over During the study - 24 weeks.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Dietressa0/164 (0%)2/164 (1.2%)76/164 (46.3%)
Placebo0/167 (0%)3/167 (1.8%)64/167 (38.3%)
Most frequent serious events
Most frequent serious events
EventDietressaPlacebo
Membranous nephropathyRenal and urinary disorders1/1640/167
PneumoniaInfections and infestations1/1641/167
Gangrenous appendicitisInfections and infestations0/1641/167
Ankle fractureInjury, poisoning and procedural complications0/1641/167
Most frequent other events
Showing 10 of 73
Most frequent other events
EventDietressaPlacebo
Increased anxietyPsychiatric disorders32/16436/167
DepressionPsychiatric disorders18/16410/167
Viral respiratory tract infectionInfections and infestations13/1648/167
Depression, worseningPsychiatric disorders12/16413/167
Increased appetiteMetabolism and nutrition disorders3/1646/167
Increased blood glucoseInvestigations4/1642/167
DyslipidemiaMetabolism and nutrition disorders3/1642/167
Abdominal painGastrointestinal disorders2/1640/167
DiarrheaGastrointestinal disorders2/1640/167
NauseaGastrointestinal disorders2/1641/167

Baseline characteristics

Age, Continuous
Age, Continuous(years)DietressaPlaceboTotal
Mean43.7 ± 11.442.8 ± 11.643.2 ± 11.5
Sex: Female, Male
Sex: Female, Male(Participants)DietressaPlaceboTotal
Female138139277
Male262854
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)DietressaPlaceboTotal
Count of participants——0
Region of Enrollment
Region of Enrollment(participants)DietressaPlaceboTotal
Russia164167331
08

Study locations

17 sites
  • The State Educational institution of High Professional Training Kuban State Medical University of Ministry of Health Care and Social Development of the Russian Federation, Department of Clinical Pharmacology
    Krasnodar, 350063, Russian Federation
  • First Moscow State Medical University named after I.M. Sechenov/Endocrinology Faculty
    Moscow, 119991, Russian Federation
  • The State Budget Health Care institution of Moscow the City Clinical Hospital No. 11 of the Administration of Health Care of Moscow City
    Moscow, 127018, Russian Federation
  • Municipal Medical and Preventive institution "City Clinical Hospital No.10"
    Nizhny Novgorod, 603011, Russian Federation
  • The State Budget Health Care institution of Nizhegorodskyi Region "Nizhegorodskaya Regional Clinical Hospital n.a. N.A.Semashko"
    Nizhny Novgorod, 603126, Russian Federation
  • The State Educational institution of High Professional Training "Rostov State Medical University" of Ministry of Health Care and Social Development of the Russian Federation, Department of Endocrinology
    Rostov na Donu, 344022, Russian Federation
  • St. Petersburg State Health Care institution "Municipal Hospital No.6"
    St. Petersburg, 191482, Russian Federation
  • St. Petersburg State Health Care institution "Municipal Hospital No.77 of Nevsky District", The City Diabetes Center
    St. Petersburg, 192177, Russian Federation
  • The Federal State Health Care institution L.G. Sokolov Memorial Hospital No. 122 of the FMBA (Federal Medical and Biological Agency).
    St. Petersburg, 194291, Russian Federation
  • The State Educational institution of High Professional Training "St. Petersburg State Medical University n.a. I.P. Pavlov of the Federal Agency for Health Care and Social Development", Therapy Faculty Board
    St. Petersburg, 197022, Russian Federation
  • St. Petersburg state Health Care institution "Saint Venerable Martyr Elizaveta Municipal Hospital"
    St. Petersburg, 197706, Russian Federation
  • St. Petersburg State Health Care institution "Consultative and Diagnostic Center No. 85", Diabetes Center
    St. Petersburg, 198260, Russian Federation
  • The State Educational institution of High Professional Training "St. Petersburg State Medical University n.a. I.P. Pavlov of the Federal Agency for Health Care and Social Development", Faculty Surgery Board
    St.Petersburg, 197022, Russian Federation
  • The State Educational institution of High Professional Training "Bashkirsky State Medical University" of the Federal Agency for Health Care and Social Development, Department of Endocrinology
    Ufa, 450000, Russian Federation
  • The State Educational institution of High Professional Training "Volgograd State Medical University" of Ministry of Health Care and Social Development of the Russian Federation
    Volgograd, 400131, Russian Federation
  • The State Health Care institution "Voronezh Regional Clinical Consultative & Diagnostic Center"
    Voronezh, 394018, Russian Federation
  • The State Health Care institution of Yaroslavl Region the Clinical Hospital
    Yaroslavl, 150062, Russian Federation
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01570829
Lead sponsor
Materia Medica Holding
Responsible party
Sponsor
First posted
Apr 4, 2012
Start date
Dec 2011
Primary completion
Jun 2013
Completion
Jun 2013
Results posted
Aug 26, 2021
Last update
Aug 26, 2021

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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