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CompletedNCT01535014Updated Nov 28, 2018Results posted

Clinical Trial of Safety and Efficacy of Various Dosage Schedules 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 2018-11-28.

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

Phase
Phase 3
Study type
Interventional
Enrollment
493
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.
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 30,0-34,9 kg/m2.
  2. Male or female subjects aged 18 to 65 inclusive.
  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, namely, 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 abepithymia.
  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. Legal incapacity or limited legal capacity.
  1. Patients, who, in the investigator's opinion, will fail to observe the requirements during the trial or adhere to the studied drug administration procedure.
  1. Participation in other clinical trials within 3 months before enrolment in this trial.
  1. 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.
  1. 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
493 participants (actual)

Study arms

  • Experimental
    Dietressa (2 tablets 3 times daily) for 24 weeks

    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

  • Experimental
    Dietressa (1 tablet 6 times daily) for 24 weeks

    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

  • Placebo comparator
    Placebo (2 tablets 3 times daily)

    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

  • Placebo comparator
    Placebo (1 tablet 6 times daily)

    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

Interventions

  • DrugDietressa

    Comparison of different dosages (frequency) of drug

  • DrugPlacebo

    Placebo either (2 tablets 3 times daily) or (1 tablet 6 times daily)

06

What researchers measure

Primary outcomes

  1. Percentage of Subjects Who Lose at Least 5 Percent of Baseline Body Weight After 24 Weeks of Treatment Weeks of Treatment

    Time frame: assessed after 24 weeks of treatment

  2. Average Body Weight Change After 24 Weeks of Treatment

    Time frame: assessed after 24 weeks of treatment

  3. Average Relative Change in Body Weight After 24 Weeks of Treatment

    Time frame: assessed after 24 weeks of treatment

Secondary outcomes

  1. 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

    Time frame: assessed after 4, 8, 12, 16, 20, and 24 weeks of treatment

  2. Average Relative Weight Change After 4, 8, 12, 16, 20 and 24 Weeks of Treatment

    Time frame: assessed after 4, 8, 12, 16, 20 and 24 weeks of treatment

  3. Waist Hip Ratio After 4, 12 and 24 Weeks of Treatment

    Time frame: assessed after 4,12 and 24 weeks of treatment

  4. 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.

    Time frame: baseline, 4, 12 and 24 weeks

07

Results

Posted Oct 18, 2018

Participant flow

Participant flow — Overall Study
MilestoneDietressa 1Dietressa 2Placebo 3Placebo 4
Started2102005033
Completed2081944933
Not completed2610

Outcome measures

PrimaryPercentage of Subjects Who Lose at Least 5 Percent of Baseline Body Weight After 24 Weeks of Treatment Weeks of Treatment
Time frame:
assessed after 24 weeks of treatment
Reported as:
Number · percentage of participants
Percentage of Subjects Who Lose at Least 5 Percent of Baseline Body Weight After 24 Weeks of Treatment Weeks of Treatment
percentage of participantsDietressa 1Dietressa 2Placebo 3Placebo 4
Percentage of Subjects Who Lose at Least 5 Percent of Baseline Body Weight After 24 Weeks of Treatment Weeks of Treatment49483321
Statistical analysis
  • Dietressa 1 vs Placebo 3 · Chi-squared · p = 0.04
  • Dietressa 2 vs Placebo 4 · Chi-squared · p = 0.004
  • Dietressa 1 vs Dietressa 2 vs Placebo 3 vs Placebo 4 · Cochran-Mantel-Haenszel · p = 0.0007
PrimaryAverage Body Weight Change After 24 Weeks of Treatment
Time frame:
assessed after 24 weeks of treatment
Reported as:
Mean · kilogram
Average Body Weight Change After 24 Weeks of Treatment
kilogramDietressa 1Dietressa 2Placebo 3Placebo 4
Average Body Weight Change After 24 Weeks of Treatment-4.4 ± 4.2-4.4 ± 4.4-3.0 ± 3.5-2.9 ± 2.8
Statistical analysis
  • Dietressa 1 vs Placebo 3 · t-test, 2 sided · p = 0.03
  • Dietressa 2 vs Placebo 4 · t-test, 2 sided · p = 0.07
PrimaryAverage Relative Change in Body Weight After 24 Weeks of Treatment
Time frame:
assessed after 24 weeks of treatment
Reported as:
Mean · percentage of body weight
Average Relative Change in Body Weight After 24 Weeks of Treatment
percentage of body weightDietressa 1Dietressa 2Placebo 3Placebo 4
Average Relative Change in Body Weight After 24 Weeks of Treatment-4.9 ± 4.7-4.9 ± 4.9-3.4 ± 4.2-3.4 ± 3.3
Statistical analysis
  • Dietressa 1 vs Placebo 3 · t-test, 2 sided · p = 0.03
  • Dietressa 2 vs Placebo 4 · t-test, 2 sided · p = 0.07
SecondaryPercentage 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
Time frame:
assessed after 4, 8, 12, 16, 20, and 24 weeks of treatment
Reported as:
Number · percentage of participants
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
percentage of participantsDietressa 1Dietressa 2Placebo 3Placebo 4
4 weeks4540
8 weeks171683
12 weeks26241215
16 weeks34361618
20 weeks38422215
24 weeks49483321
Statistical analysis
  • Dietressa 1 vs Placebo 3 · Chi-squared · p = <0.05 (For week 12, 16, 20, 24)
  • Dietressa 2 vs Placebo 4 · Chi-squared · p = <0.05 (For week 16, 20, 24)
SecondaryAverage Relative Weight Change After 4, 8, 12, 16, 20 and 24 Weeks of Treatment
Time frame:
assessed after 4, 8, 12, 16, 20 and 24 weeks of treatment
Reported as:
Mean · percentage of body weight
Average Relative Weight Change After 4, 8, 12, 16, 20 and 24 Weeks of Treatment
percentage of body weightDietressa 1Dietressa 2Placebo 3Placebo 4
4 weeks-1.5 ± 1.8-1.4 ± 2.1-0.8 ± 2.1-0.8 ± 1.4
8 weeks-2.5 ± 2.6-2.5 ± 2.7-1.3 ± 3.8-1.5 ± 1.9
12 weeks-3.2 ± 3.1-3.3 ± 3.4-2.1 ± 3.2-2.2 ± 2.7
16 weeks-3.9 ± 3.7-4.0 ± 3.9-2.8 ± 3.7-2.6 ± 2.8
20 weeks-4.3 ± 4.1-4.5 ± 4.4-3.1 ± 4.0-2.8 ± 3.1
24 weeks-4.9 ± 4.7-4.9 ± 4.9-3.4 ± 4.2-3.4 ± 3.3
Statistical analysis
  • Dietressa 1 vs Placebo 3 · ANCOVA · p = 0.019
  • Dietressa 2 vs Placebo 4 · ANCOVA · p = 0.043
SecondaryWaist Hip Ratio After 4, 12 and 24 Weeks of Treatment
Time frame:
assessed after 4,12 and 24 weeks of treatment
Reported as:
Mean · waist hip ratio
Waist Hip Ratio After 4, 12 and 24 Weeks of Treatment
waist hip ratioDietressa 1Dietressa 2Placebo 3Placebo 4
0 week0.88 ± 0.080.89 ± 0.090.89 ± 0.070.86 ± 0.08
4 weeks0.88 ± 0.080.89 ± 0.090.88 ± 0.080.85 ± 0.08
12 weeks0.88 ± 0.080.88 ± 0.090.87 ± 0.080.85 ± 0.08
24 weeks0.87 ± 0.080.88 ± 0.090.87 ± 0.080.85 ± 0.08
Statistical analysis
  • Dietressa 1 vs Placebo 3 · ANCOVA · p = 0.20
  • Dietressa 2 vs Placebo 4 · ANCOVA · p = 0.75
SecondaryChange 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.

Time frame:
baseline, 4, 12 and 24 weeks
Reported as:
Mean · scores on a scale
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
scores on a scaleDietressa 1Dietressa 2Placebo 3Placebo 4
0 week (mental)43.7 ± 9.543.4 ± 10.444.3 ± 9.547.5 ± 7.3
4 weeks (mental)46.4 ± 9.346.1 ± 9.849.0 ± 9.149.5 ± 8.0
12 weeks (mental)46.5 ± 9.346.6 ± 10.249.3 ± 6.349.0 ± 8.6
24 weeks (mental)48.3 ± 8.747.5 ± 9.250.6 ± 7.050.0 ± 8.6
0 week (physical)50.0 ± 7.949.5 ± 7.349.5 ± 7.350.7 ± 7.6
4 weeks (physical)51.2 ± 7.150.1 ± 6.851.0 ± 6.851.5 ± 6.9
12 weeks (physical)52.2 ± 6.450.8 ± 7.251.3 ± 5.950.7 ± 7.8
24 weeks (physical)52.4 ± 6.551.3 ± 6.951.7 ± 6.252.3 ± 6.2
Statistical analysis
  • Dietressa 1 vs Placebo 3 · ANCOVA · p = 0.02
  • Dietressa 2 vs Placebo 4 · ANCOVA · p = 0.63
  • Dietressa 1 vs Placebo 3 · ANCOVA · p = 0.60
  • Dietressa 2 vs Placebo 4 · ANCOVA · p = 0.98

Adverse events

Collected over Adverse/Serious adverse events were registered during 12 months of therapy and 30 days after the end of the research. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Dietressa 1+2—3/410 (0.7%)160/410 (39%)
Placebo 3+4—0/83 (0%)33/83 (39.8%)
Most frequent serious events
Most frequent serious events
EventDietressa 1+2Placebo 3+4
Uterine bleedingReproductive system and breast disorders1/4100/83
Pregnancy NOSPregnancy, puerperium and perinatal conditions1/4100/83
Intervertebral disc sequestrationMusculoskeletal and connective tissue disorders1/4100/83
Vertebral osteochondrosisMusculoskeletal and connective tissue disorders1/4100/83
Most frequent other events
Showing 10 of 85
Most frequent other events
EventDietressa 1+2Placebo 3+4
Increased anxiety on a scale HADSPsychiatric disorders42/4108/83
Increased depression on a scale HADSPsychiatric disorders36/4104/83
Subclinical anxietyPsychiatric disorders32/4106/83
Increased appetiteMetabolism and nutrition disorders11/4106/83
Subclinical depressionPsychiatric disorders20/4102/83
Acute respiratory viral infectionInfections and infestations12/4104/83
EosinophiliaBlood and lymphatic system disorders1/4103/83
Acute rhinopharyngitisInfections and infestations2/4102/83
Erythrocyte sedimentation rate increaseInvestigations2/4102/83
ALT increaseInvestigations0/4102/83

Baseline characteristics

Age, Continuous
Age, Continuous(years)Dietressa 1Dietressa 2Placebo 3Placebo 4Total
Mean41.2 ± 12.142.4 ± 12.141.4 ± 10.342.8 ± 11.341.9 ± 11.8
Sex: Female, Male
Sex: Female, Male(Participants)Dietressa 1Dietressa 2Placebo 3Placebo 4Total
Female1811674430422
Male27275362
Height
Height(centimeter)Dietressa 1Dietressa 2Placebo 3Placebo 4Total
Mean166.4 ± 8.3165.1 ± 7.9164.4 ± 6.7164.9 ± 7.8165.6 ± 8.0
Weight
Weight(kilogram)Dietressa 1Dietressa 2Placebo 3Placebo 4Total
Mean89.1 ± 10.687.5 ± 9.587.1 ± 7.786.1 ± 9.888.1 ± 9.9
BMI
BMI(kilogram/m^2)Dietressa 1Dietressa 2Placebo 3Placebo 4Total
Mean32.1 ± 1.432.0 ± 1.532.2 ± 1.531.6 ± 1.332.0 ± 1.4
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
  • The State Educational institution of High Professional Training I.M. Sechenov First Moscow State Medical University of Ministry of Health Care and Social Development of the Russian Federation, 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 Nov 28, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01535014
Lead sponsor
Materia Medica Holding
Responsible party
Sponsor
First posted
Feb 17, 2012
Start date
Dec 12, 2011
Primary completion
Jun 2013
Completion
Jun 2013
Results posted
Oct 18, 2018
Last update
Nov 28, 2018

Oversight

Data monitoring committee
No
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