ObesityPhase 3NCT01570829

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

A Phase 3 study testing Dietressa in people with Obesity, run by Materia Medica Holding at 17 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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 more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Obesity
What is being tested?: Dietressa
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 331 participants
Where: 17 sitesRussia
Study dates: Dec 2011to Jun 2013
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Outpatient subjects with BMI 35,0-39,9 kg/m2.
Males or females aged from 18 to 65 years.
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.

Who cannot join

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.).
Compliance with a diet prescribed and monitored by the doctor to reduce body weight within 6 months before enrollment.

Show all 29Show fewer

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 anorexia.
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.
Patients, who, in the investigator's opinion, will fail to observe the requirements during the trial or adhere to the studied drug administration procedure.
Participation in other clinical trials within 3 months before enrolment in this trial.
Presence of other factors, complicating the patient's participation in the trial (e.g., planned lengthy business and other trips).
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.
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.

Trial locations and contacts

17 sites in 1 country.

City, postcode or hospital

17 sites in 1 country

Russia17 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
First Moscow State Medical University named after I.M. Sechenov/Endocrinology Faculty
Moscow, 119991
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
Municipal Medical and Preventive institution "City Clinical Hospital No.10"
Nizhny Novgorod, 603011
The State Budget Health Care institution of Nizhegorodskyi Region "Nizhegorodskaya Regional Clinical Hospital n.a. N.A.Semashko"
Nizhny Novgorod, 603126
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-on-Don, 344022
St. Petersburg State Health Care institution "Municipal Hospital No.6"
Saint Petersburg, 191482
St. Petersburg State Health Care institution "Municipal Hospital No.77 of Nevsky District", The City Diabetes Center
Saint Petersburg, 192177
The Federal State Health Care institution L.G. Sokolov Memorial Hospital No. 122 of the FMBA (Federal Medical and Biological Agency).
Saint Petersburg, 194291
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
Saint Petersburg, 197022
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
Saint Petersburg, 197022
St. Petersburg state Health Care institution "Saint Venerable Martyr Elizaveta Municipal Hospital"
Saint Petersburg, 197706
St. Petersburg State Health Care institution "Consultative and Diagnostic Center No. 85", Diabetes Center
Saint Petersburg, 198260
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
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
The State Health Care institution "Voronezh Regional Clinical Consultative & Diagnostic Center"
Voronezh, 394018
The State Health Care institution of Yaroslavl Region the Clinical Hospital
Yaroslavl, 150062

Other trials in Russia

About this study

Official title: Multicentric Double-blind Placebo-controlled Randomized Parallel-group Clinical Trial of Safety and Efficacy of New Dosage Schedule for Dietressa Drug in Treatment of Obese Patients

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.

Conditions: Obesity
Being tested: Dietressa, Placebo
Medical subject headings: Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DietressaDrug
Oral administration.
PlaceboDrug
Oral administration.

Study groups in NCT01570829
Study group	Role	What they receive
Dietressa	Experimental	Tablet for oral use. 1 tablet 6 times a day. The duration of Dietressa therapy is 24 weeks. Receives: Drug: Dietressa
Placebo	Placebo comparator	Tablet for oral use. 1 tablet 6 times a day. The duration of Placebo therapy is 24 weeks. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Patients With at Least 5% Weight Loss.
Based on medical records.
Measured: 24 weeks
Average Absolute Weight Change
Based on medical records.
Measured: On baseline and after 24 weeks
Average Relative Weight Change
Based on medical records.
Measured: On baseline and after 24 weeks

Secondary outcomes (5)

Percentage of Patients With at Least 5% Weight Loss.
Based on medical records.
Measured: On baseline and after 4, 8, 12, 16, 20, 24 weeks of treatment
Average Absolute Weight Change
Based on medical records.
Measured: After 4, 8, 12, 16 and 20 weeks of treatment
Average Relative Weight Change
Based on medical records.
Measured: After 4, 8, 12, 16 and 20 weeks of treatment
Change in Waist Circumference, Waist Circumference/Hip Circumference.
Based on medical records.
Measured: After 4, 12 and 24 weeks of treatment
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
Measured: On baseline and after 4, 12, 24 weeks of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2011Jun 2013

First posted4 Apr 2012 (estimated)
Study startDec 2011
Primary completionJun 2013
Study completionJun 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for ObesityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 331 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01570829
Sponsor's protocol ID: MMH-DI-003
Status last verified: Jan 2019
First submitted: 2 Apr 2012
Last updated: 26 Aug 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Obesity trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multicentric Double-blind Placebo-controlled Randomized Parallel-group Clinical Trial of Safety and Efficacy of New Dosage Schedule for Dietressa Drug in Treatment of Obese Patients
ClinicalTrials.gov ID: NCT01570829
Acronym / sponsor ID: MMH-DI-003
Conditions: Obesity
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 331 participants (actual)
Lead sponsor: Materia Medica HoldingIndustry (pharma, biotech, devices)
Study start: Dec 2011
Primary completion: Jun 2013 (actual)
Study completion: Jun 2013 (actual)
First posted: 4 Apr 2012 (estimated)
Results: Posted 26 Aug 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Dietressa	Experimental	Drug: DietressaTablet for oral use. 1 tablet 6 times a day. The duration of Dietressa therapy is 24 weeks.
Placebo	Placebo comparator	Drug: PlaceboTablet for oral use. 1 tablet 6 times a day. The duration of Placebo therapy is 24 weeks.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Outpatient subjects with BMI 35,0-39,9 kg/m2.
Males or females aged from 18 to 65 years.
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.

Key exclusion criteria (29 listed)

Symptomatic (secondary) obesity:
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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DietressaOral administration.	Drug	Dietressa
PlaceboOral administration.	Drug	Placebo

Primary outcome

Percentage of Patients With at Least 5% Weight Loss.
Time frame: 24 weeks
Based on medical records.
Average Absolute Weight Change
Time frame: On baseline and after 24 weeks
Based on medical records.
Average Relative Weight Change
Time frame: On baseline and after 24 weeks
Based on medical records.

5 secondary outcomes

Percentage of Patients With at Least 5% Weight Loss.
Time frame: On baseline and after 4, 8, 12, 16, 20, 24 weeks of treatment
Average Absolute Weight Change
Time frame: After 4, 8, 12, 16 and 20 weeks of treatment
Average Relative Weight Change
Time frame: After 4, 8, 12, 16 and 20 weeks of treatment
Change in Waist Circumference, Waist Circumference/Hip Circumference.
Time frame: After 4, 12 and 24 weeks of treatment
Dynamics of the Quality of Life According to the SF-36 Questionnaire.
Time frame: On baseline and after 4, 12, 24 weeks of treatment

Results and safety

Results posted to the registry on 26 Aug 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dietressa	164	164
Placebo	167	167

Primary outcome: Percentage of Patients With at Least 5% Weight Loss.

Time frame: 24 weeks. Count of participants. Unit: Participants

Measure	Dietressa n = 164	Placebo n = 167
Value	80	62

Dietressa vs Placebo: p = 0.0352, Fisher Exact

Primary outcome: Average Absolute Weight Change

Time frame: On baseline and after 24 weeks. Mean (Standard Deviation). Unit: kilogram

Measure	Dietressa n = 164	Placebo n = 167
Baseline	104.7 (11.6)	105.3 (11.4)
After 24 weeks	98.6 (12.7)	101.3 (12.1)
∆ between baseline and after 24 weeks	6.1 (5.3)	4.0 (4.6)

Dietressa vs Placebo: p = 0.0001, Wilcoxon (Mann-Whitney)

Primary outcome: Average Relative Weight Change

Time frame: On baseline and after 24 weeks. Mean (Standard Deviation). Unit: percentage of weight loss from baseline

Measure	Dietressa n = 164	Placebo n = 167
Value	5.9 (5.1)	3.8 (4.4)

Dietressa vs Placebo: p = 0.0001, Wilcoxon (Mann-Whitney)

Population analysed: ∆ between baseline and after 24 weeks

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: During the study - 24 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dietressa	2 of 164 (1.2%)	76 of 164 (46.3%)	0 of 164
Placebo	3 of 167 (1.8%)	64 of 167 (38.3%)	0 of 167

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

17 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dietressa in people with Obesity, run by Materia Medica Holding at 17 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Patients With at Least 5% Weight Loss. (time frame: 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01570829.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2021.