Efficacy and Safety of Sibutramin-containing Drugs in Patient With Alimentary Obesity

NCT05821543 | Completed Phase 4

• 1 other identifier: KI/0619-1
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 8

Brief 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. Petersburg, Ivanovo, Kirov, Samara, Rostov-on-Don) on the basis of 8 research centers.

Conditions

Obesity

Keywords

obesity; sibutramine; metformin; Reduxin; Reduxin Forte; pharmacotherapy

Outcome Measures

Primary Outcomes (1)

• The rate of achieving >5% weight loss

  The proportion of patients who had achieved more than 5% weight loss

  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

  From baseline to Visit 3 (30±1 days)

• The magnitude of the change in body weight

  From baseline to Visit 13 (study completion, 180 days)

• The change in Body Mass Index (BMI)

  From baseline to Visit 13 (study completion, 180 days)

• The dynamic of body weight

  From baseline to Visit 13 (study completion, 180 days)

• The dynamic of BMI

  From baseline to Visit 13 (study completion, 180 days)

Study Arms (2)

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.

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.

Drug: sibutramine+ microcrystalline cellulose

Interventions

metformin+sibutramine DRUG

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)

Also known as: Reduxin® Forte

Reduxin Forte

sibutramine+ microcrystalline cellulose DRUG

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)

Also known as: Reduxin®

Reduxin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Promomed, LLC: lead

Study Sites (8)

Ivanovo Clinical Hospital named after Kuvaev

Ivanovo, Russia

Location

Kirov State Medical University

Kirov, Russia

Location

Pirogov Russian National Research Medical University

Moscow, Russia

Location

"Rostov State Medical University" of the Ministry of Health of the Russian Federation

Rostov-on-Don, Russia

Location

"Clinical hospital "RZD-Medicine" of the city of St. Petersburg"

Saint Petersburg, Russia

Location

Avrora Limited Liability Company Principal

Saint Petersburg, Russia

Location

Limited Liability Company "Medica"

Saint Petersburg, Russia

Location

OrKli Hospital Limited Liability Company

Saint Petersburg, Russia

Location

Related Publications (1)

• 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

  BACKGROUND

Related Links

• "Pharmacy \& Pharmacology" ("Farmatsiya i farmakologiya") peer-reviewed scientific Journal is meant for scintifical and educational pharmaceutical and medical establishments, pharmaceutical enterprises, research organizations.

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tatyana Demidova

  Pirogov Russian National Research Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2023
• First Posted: April 20, 2023
• Study Start: July 3, 2020
• Primary Completion: May 21, 2021
• Study Completion: May 21, 2021
• Last Updated: April 24, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

RU (8)