ObesityPhase 4NCT05821543
Efficacy and Safety of Sibutramin-containing Drugs in Patient With Alimentary Obesity
A Phase 4 study testing metformin+sibutramine and sibutramine+ microcrystalline cellulose in people with Obesity, run by Promomed, LLC at 8 sites in Russia.
Trial summary
This is Open multicenter randomized Phase IV study to evaluate the efficacy and safety of the drug Reduxin® Forte, film-coated tablets, in comparison with the drug Reduxin®, capsules, in patients with alimentary obesity was conducted in 5 cities of the Russian Federation (St. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- metformin+sibutramine and sibutramine+ microcrystalline cellulose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 8 sitesRussia
- Study dates
- 3 Jul 2020to 21 May 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Availability of the Informed Consent Form of the Patient Information Leaflet (PIL) signed and dated by patient.
- Men and women aged 18 to 65 years inclusive at the time of signing the Informed Consent Form in PIL.
- The presence of alimentary obesity.
- BMI >30 kg/m2.
- Failure of non-pharmacological treatment at the time of screening (weight loss <5% within 3 months of treatment).
- Patient consent to change in diet, eating behavior, and increased physical activity, and adherence to the investigator's recommendations throughout participation in the study
Show all 9Show fewer
- Patient's consent to use reliable contraceptive methods through out the study and for 3 weeks after the end of the study. The following people could take part in the study:
- women who have a negative pregnancy test and use the following contraceptive methods: a barrier method (condom or occlusive cap (diaphragm or cervical/vaulted cap)) or a double barrier method of contraception (condom or occlusive cap). The use of estrogen-containing contraceptives was allowed provided that the drug was used in one dosing regimen for at least 3 months prior to study entry and it was planned to use it at the same dosing regimen throughout the study participation. Women incapable of childbearing may also participate in the study (with past history of: hysterectomy, tubal ligation, infertility, menopause for more than 1 year) or
- men with preserved reproductive function using barrier contraceptives, as well as men with infertility or a history of vasectomy
Who cannot join
- Hypersensitivity to the components of the study drug/comparator drug
- Secondary (symptomatic) obesity.
- Diabetes mellitus type I or II in history and/or at the time of screening.
- Use of a low-calorie (<1600 kcal/day) diet for 3 months prior to screening.
- Patients who previously received drugs based on sibutramine.
- The use of drugs, herbal remedies or dietary supplements for the treatment of obesity less than 3 months prior to screening.
Show all 44Show fewer
- Use of systemic glucocorticosteroids for less than 3 months prior to screening.
- Plan to change current smoking status during the study or quit smoking less than 3 months prior to screening.
- The need for surgical treatment of obesity during the study or the history of this treatment.
- Impaired liver function (AST and/or ALT ≥ 2 UNL and/or total bilirubin ≥ 1.5 UNL) at the time of screening.
- Impaired renal function (creatinine clearance, calculated according to the Cockcroft- Gault formula, less than 45 ml/min) at the time of screening.
- Acute conditions in which there was a risk of developing impaired renal function:
- dehydration (with diarrhea, vomiting), severe infectious diseases, shock (at the time of screening).
- Cardiovascular diseases (in history and/or at the time of screening): ischemic heart disease (myocardial infarction, angina pectoris), chronic heart failure in the stage of decompensation, occlusive diseases of peripheral arteries, tachycardia (HR> 90 beats/min (mean for 3 measurements)), arrhythmia, cerebrovascular diseases (stroke, transient disorders of cerebral circulation).
- Uncontrollable hypertension (blood pressure (BP) >145/90 mm Hg on screening).
- History of pulmonary hypertension.
- Clinically apparent manifestations of acute and chronic diseases that could lead to the development of tissue hypoxia (including respiratory failure, heart failure).
- Hyperthyroidism.
- Uncontrolled hypothyroidism at the time of screening (if using thyroid drugs or synthetic thyroid hormones, the drugs must have been used at a stable dose for at least 3 months prior to screening).
- Subclinical hypothyroidism at the time of screening.
- Benign prostatic hyperplasia (for men) in history.
- Pheochromocytoma in history or suspicion of its presence at screening.
- Angle-closure glaucoma in history.
- Lactic acidosis (in history and at the time of screening).
- Chronic alcoholism, acute ethanol poisoning at the time of screening.
- Pharmacological and drug dependence in history and / or at the time of screening.
- Serious eating disorders (anorexia nervosa, bulimia nervosa).
- History of cholelithiasis or presence of symptoms of cholelithiasis within 3 months prior to screening.
- History of schizophrenia, schizoaffective disorder, bipolar disorder, or other psychiatric disorder or suspected of having them at the time of screening.
- History of suicide attempt.
- Syndrome of Gilles de la Tourette (generalized tics) in history.
- Major surgery or trauma (associated with a risk to the patient's life) in the last 6 months before screening.
- Planned surgery (elective surgery) at the time of screening
- Uncontrolled asthma or asthma controlled by steroids.
- History of seizures (with the exception of febrile seizures in childhood) or an increased risk of developing seizures.
- HIV, viral hepatitis B and/or C, history of active tuberculosis.
- The need for the use of drugs from the list of prohibited therapies.
- Taking other medications that, in the opinion of the investigator, could affect the course and results of the clinical trial.
- History of malignant neoplasms, except for patients who have not been observed for the disease within the last 5 years, patients with completely healed basal cell skin cancer or completely healed carcinoma in situ.
- Severe, decompensated or unstable somatic diseases (any disease or condition that threatened the patient's life or worsened the patient's prognosis, and also made it impossible for him to participate in a clinical study).
- Patient's unwillingness or inability to comply with procedures of the Study Protocol (in the opinion of the investigator).
- Pregnancy or breastfeeding period (for women).
- Participation in another clinical trial within 3 months prior to study enrollment.
- Other conditions that, in the opinion of the investigator, prevented the inclusion of the patient in the study.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Russia8 sites
Ivanovo Clinical Hospital named after Kuvaev
Ivanovo
Kirov State Medical University
Kirov
Pirogov Russian National Research Medical University
Moscow
"Rostov State Medical University" of the Ministry of Health of the Russian Federation
Rostov-on-Don
"Clinical hospital "RZD-Medicine" of the city of St. Petersburg"
Saint Petersburg
Avrora Limited Liability Company Principal
Saint Petersburg
Limited Liability Company "Medica"
Saint Petersburg
OrKli Hospital Limited Liability Company
Saint Petersburg
About this study
Official title: An Open-label, Multicentre, Randomized Comparative Study to Evaluate the Efficacy and Safety of Using the Sibutramin-containing Drugs Reduxin® Forte and Reduxin® in Patients With Alimentary Obesity
This is Open multicenter randomized Phase IV study to evaluate the efficacy and safety of the drug Reduxin® Forte, film-coated tablets, in comparison with the drug Reduxin®, capsules, in patients with alimentary obesity was conducted in 5 cities of the Russian Federation (St. Petersburg, Ivanovo, Kirov, Samara, Rostov-on-Don) on the basis of 8 research centers.
Read the detailed description
Male and female patients (240 people) inclusive with alimentary obesity, meeting the inclusion criteria and not meeting the non-inclusion criteria, were randomized into 2 groups in a 1:1 ratio. One group (n=120) received sibutramine+ metformin p. o., 1 tablet (850 mg + 10 mg) once per day, the second group (n=120) received sibutramine+ microcrystalline cellulose (MCC) p. o., 1 capsule (10 mg + 158.5 mg) once per day in the morning. On day 30 ± 1, in the absence of a 2 kg weight loss compared to the first visit, the dose was increased in accordance with the medical instruction. The therapy period was 180 days.
- Conditions
- Obesity
- Being tested
- metformin+sibutramine, sibutramine+ microcrystalline cellulose
- Keywords
- obesity, sibutramine, metformin, Reduxin, Reduxin Forte, pharmacotherapy
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metformin+sibutramineDrug
Also called Reduxin® Forte
1 tablet (850 mg + 10 mg) once per day in the morning, without chewing and followed with a glass of water, during meals, for 180 days. At Visit 3 (Day 30 ± 1), in the absence of a 2 kg weight loss compared to Visit1 (Day 1), the zero dose was increased to 1 tablet (850 mg + 15 mg)
sibutramine+ microcrystalline celluloseDrug
Also called Reduxin®
1 capsule (10 mg + 158.5 mg) once per day in the morning, without chewing and followed with a glass of water, during meals for, 180 days.At Visit 3 (Day 30 ± 1), in the absence of a 2 kg weight loss compared to Visit 1 (Day 1), the zero dose was increased to 1 capsule (15 mg + 153,5 mg)
| Study group | Role | What they receive |
|---|---|---|
| Reduxin Forte | Experimental | Arm 1 (n=120) received metformin+sibutramine p. o., 1 tablet (850 mg + 10 mg) once per day. On day 30 ± 1, in the absence of a 2 kg weight loss compared to the first visit, the dose was increased in accordance with the medical instruction. The therapy period was 180 days. Receives: Drug: metformin+sibutramine |
| Reduxin | Active comparator | Arm 2 (n=120) received sibutramine+ microcrystalline cellulose (MCC) p. o., 1 capsule (10 mg + 158.5 mg) once per day in the morning. On day 30 ± 1, in the absence of a 2 kg weight loss compared to the first visit, the dose was increased in accordance with the medical instruction. The therapy period was 180 days. Receives: Drug: sibutramine+ microcrystalline cellulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of achieving >5% weight loss
The proportion of patients who had achieved more than 5% weight loss
Measured: From baseline to Visit 13 (study completion, 180 days)
Secondary outcomes (10)
The frequency of patients who required an increase in the dose of the study / reference drug
The proportion of the patients requiring an increase in the study / reference dose
Measured: From baseline to Visit 3 (30±1 days)
The magnitude of the change in body weight
Value of weight change calculated as weight on Visit 13 to baseline (kg)
Measured: From baseline to Visit 13 (study completion, 180 days)
The change in Body Mass Index (BMI)
The average value of the change in BMI (%)
Measured: From baseline to Visit 13 (study completion, 180 days)
The dynamic of body weight
The mean body weight by each two weeks (kg)
Measured: From baseline to Visit 13 (study completion, 180 days)
The dynamic of BMI
The average value of BMI by every month (kg/m2)
Measured: From baseline to Visit 13 (study completion, 180 days)
The dynamic of waist measurement
The average waist measurement by every month(cm)
Measured: From baseline to Visit 13 (study completion, 180 days)
The dynamic of hip width
The average hip width by every month(cm)
Measured: From baseline to Visit 13 (study completion, 180 days)
The dynamic of waist / hip measurements
The average value of the ratio waist / hip measurements by every month
Measured: From baseline to Visit 13 (study completion, 180 days)
Dynamics of lipid profile indicators (TG, total cholesterol, LDL-cholesterol, HDL-cholesterol)
The mean value of triglyceride, total cholesterol, LDL- cholesterol, HDL - cholesterol (mmol/l) by every month
Measured: From baseline to Visit 13 (study completion, 180 days)
The dynamic of quality of life
The data obtained using the SF-36 Quality of life questionnaire, the average score of the physical health and psychological health by every month
Measured: From baseline to Visit 13 (study completion, 180 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start3 Jul 2020
- Primary completion21 May 2021
- Study completion21 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Promomed, LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tatyana Demidova, Principal investigator, Pirogov Russian National Research Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05821543
- Sponsor's protocol ID
- KI/0619-1
- Status last verified
- Apr 2023
- First submitted
- 7 Apr 2023
- Last updated
- 24 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Demidova T.Yu., Izmailova M.Y., Ushakova S.E., Zaslavskaya K.Y., Odegova A.A., Popova V.V., Nevretdinova M.E., Bely P.A. EVALUATION OF WEIGHT REDUCTION EFFICACY AND SAFETY OF SIBUTRAMIN-CONTAINING DRUGS IN PATIENTS WITH ALIMENTARY OBESITY. Pharmacy & Pharmacology. 2022;10(3):289-304. https://doi.org/10.19163/2307-9266-2022-10-3-289-304
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicentre, Randomized Comparative Study to Evaluate the Efficacy and Safety of Using the Sibutramin-containing Drugs Reduxin® Forte and Reduxin® in Patients With Alimentary Obesity
- ClinicalTrials.gov ID
- NCT05821543
- Acronym / sponsor ID
- KI/0619-1
- Conditions
- Obesity
- Keywords
- obesity, sibutramine, metformin, Reduxin, Reduxin Forte, pharmacotherapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Promomed, LLCUniversity, hospital or other
- Study start
- 3 Jul 2020 (actual)
- Primary completion
- 21 May 2021 (actual)
- Study completion
- 21 May 2021 (actual)
- First posted
- 20 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is Open multicenter randomized Phase IV study to evaluate the efficacy and safety of the drug Reduxin® Forte, film-coated tablets, in comparison with the drug Reduxin®, capsules, in patients with alimentary obesity was conducted in 5 cities of the Russian Federation (St. Petersburg, Ivanovo, Kirov, Samara, Rostov-on-Don) on the basis of 8 research centers.
Detailed description
Male and female patients (240 people) inclusive with alimentary obesity, meeting the inclusion criteria and not meeting the non-inclusion criteria, were randomized into 2 groups in a 1:1 ratio. One group (n=120) received sibutramine+ metformin p. o., 1 tablet (850 mg + 10 mg) once per day, the second group (n=120) received sibutramine+ microcrystalline cellulose (MCC) p. o., 1 capsule (10 mg + 158.5 mg) once per day in the morning. On day 30 ± 1, in the absence of a 2 kg weight loss compared to the first visit, the dose was increased in accordance with the medical instruction. The therapy period was 180 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reduxin Forte | Experimental | Drug: metformin+sibutramineArm 1 (n=120) received metformin+sibutramine p. o., 1 tablet (850 mg + 10 mg) once per day. On day 30 ± 1, in the absence of a 2 kg weight loss compared to the first visit, the dose was increased in accordance with the medical instruction. The therapy period was 180 days. |
| Reduxin | Active comparator | Drug: sibutramine+ microcrystalline celluloseArm 2 (n=120) received sibutramine+ microcrystalline cellulose (MCC) p. o., 1 capsule (10 mg + 158.5 mg) once per day in the morning. On day 30 ± 1, in the absence of a 2 kg weight loss compared to the first visit, the dose was increased in accordance with the medical instruction. The therapy period was 180 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Availability of the Informed Consent Form of the Patient Information Leaflet (PIL) signed and dated by patient.
- Men and women aged 18 to 65 years inclusive at the time of signing the Informed Consent Form in PIL.
- The presence of alimentary obesity.
- BMI >30 kg/m2.
- Failure of non-pharmacological treatment at the time of screening (weight loss <5% within 3 months of treatment).
Key exclusion criteria (44 listed)
- Hypersensitivity to the components of the study drug/comparator drug
- Secondary (symptomatic) obesity.
- Diabetes mellitus type I or II in history and/or at the time of screening.
- Use of a low-calorie (<1600 kcal/day) diet for 3 months prior to screening.
- Patients who previously received drugs based on sibutramine.
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 |
|---|---|---|
| metformin+sibutramineAlso: Reduxin® Forte1 tablet (850 mg + 10 mg) once per day in the morning, without chewing and followed with a glass of water, during meals, for 180 days. At Visit 3 (Day 30 ± 1), in the absence of a 2 kg weight loss compared to Visit1 (Day 1), the zero dose was increased to 1 tablet (850 mg + 15 mg) | Drug | Reduxin Forte |
| sibutramine+ microcrystalline celluloseAlso: Reduxin®1 capsule (10 mg + 158.5 mg) once per day in the morning, without chewing and followed with a glass of water, during meals for, 180 days.At Visit 3 (Day 30 ± 1), in the absence of a 2 kg weight loss compared to Visit 1 (Day 1), the zero dose was increased to 1 capsule (15 mg + 153,5 mg) | Drug | Reduxin |
Primary outcome
The rate of achieving >5% weight loss
Time frame: From baseline to Visit 13 (study completion, 180 days)
The proportion of patients who had achieved more than 5% weight loss
10 secondary outcomes
The frequency of patients who required an increase in the dose of the study / reference drug
Time frame: From baseline to Visit 3 (30±1 days)
The magnitude of the change in body weight
Time frame: From baseline to Visit 13 (study completion, 180 days)
The change in Body Mass Index (BMI)
Time frame: From baseline to Visit 13 (study completion, 180 days)
The dynamic of body weight
Time frame: From baseline to Visit 13 (study completion, 180 days)
The dynamic of BMI
Time frame: From baseline to Visit 13 (study completion, 180 days)
The dynamic of waist measurement
Time frame: From baseline to Visit 13 (study completion, 180 days)
The dynamic of hip width
Time frame: From baseline to Visit 13 (study completion, 180 days)
The dynamic of waist / hip measurements
Time frame: From baseline to Visit 13 (study completion, 180 days)
Dynamics of lipid profile indicators (TG, total cholesterol, LDL-cholesterol, HDL-cholesterol)
Time frame: From baseline to Visit 13 (study completion, 180 days)
The dynamic of quality of life
Time frame: From baseline to Visit 13 (study completion, 180 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
- BackgroundDemidova T.Yu., Izmailova M.Y., Ushakova S.E., Zaslavskaya K.Y., Odegova A.A., Popova V.V., Nevretdinova M.E., Bely P.A. EVALUATION OF WEIGHT REDUCTION EFFICACY AND SAFETY OF SIBUTRAMIN-CONTAINING DRUGS IN PATIENTS WITH ALIMENTARY OBESITY. Pharmacy & Pharmacology. 2022;10(3):289-304. https://doi.org/10.19163/2307-9266-2022-10-3-289-304
- "Pharmacy \& Pharmacology" ("Farmatsiya i farmakologiya") peer-reviewed scientific Journal is meant for scintifical and educational pharmaceutical and medical establishments, pharmaceutical enterprises, research organizations.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
Tatyana Demidova principal investigator
Pirogov Russian National Research Medical University
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing metformin+sibutramine and sibutramine+ microcrystalline cellulose in people with Obesity, run by Promomed, LLC at 8 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 9 inclusion and 44 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 24 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The rate of achieving >5% weight loss (time frame: From baseline to Visit 13 (study completion, 180 days)). 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 NCT05821543, which also lists 1 linked publication.
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 24 Apr 2023.