Assess the Additional Weight Loss Effect of Orlistat Used in Combination With Sibutramine

NCT01184560 | Completed DMC

• 1 other identifier: HM-OPS
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study, conducted academic Pilot research purposes, this is not clear as to permit. when orlistat to sibutramine merge if there are additional effects of BMI and group, which has an attribute that is greater for the combined effect is to analyze.

• Study phase: Investigator-initiated clinical study (Pilot study)
• Method of blinding: Double-blind
• Control: Placebo-controlled
• Assignment method: Randomization (Sibutramine monotherapy group: Orlistat and Sibutramine combination group = 1 : 1)
• Studied disease: Obesity
• Study population: Subjects eligible for inclusion/exclusion criteria
• Dosing period: Total 18 weeks Run-in period (2 weeks), dosing period (12 weeks) and post-dosing observation period (4 weeks)

Conditions

Obesity

Keywords

obesity

Outcome Measures

Primary Outcomes (6)

• Weight

  Weight

  with in 18weeks

• BMI(Body Mass Index)

  BMI(Body Mass Index)

  with in 18weeks

• waist circumference

  waist circumference

  with in 18weeks

• blood pressure

  blood pressure

  with in 18weeks

• fat mass

  fat mass

  with in 18weeks

• visceral fat mass improvement

  visceral fat mass improvement

  with in 18weeks

Secondary Outcomes (2)

• Lipid profile

  with in 18weeks

• Adipokines improvement

  with in 18weeks

Study Arms (2)

Sibutramine + Orlistat

EXPERIMENTAL

A lipase inhibitor used for weight loss. Lipase is an enzyme found in the bowel that assists in lipid absorption by the body. Orlistat blocks this enzyme, reducing the amount of fat the body absorbs by about 30%. It is known as a "fat blocker". Because more oily fat is left in the bowel to be excreted, Orlistat can cause an oily anal leakage and fecal incontinence

Drug: Sibutramine; Drug: Orlistat

Sibutramine + Orlistat(Placebo)

PLACEBO COMPARATOR

1. Sibutramine : one of components included into Diet Pills. This reduces appetite, normalizes amount of cholesterol in blood, and reduces abdominal fat. 2. Orlistat : A lipase inhibitor used for weight loss. Lipase is an enzyme found in the bowel that assists in lipid absorption by the body. Orlistat blocks this enzyme, reducing the amount of fat the body absorbs by about 30%. It is known as a "fat blocker". Because more oily fat is left in the bowel to be excreted, Orlistat can cause an oily anal leakage and fecal incontinence.

Drug: Sibutramine; Drug: Orlistat

Interventions

Sibutramine DRUG

○ Dosing standard Run-in period: All subjects would administer Sibutramine placebo 1 capsule (once daily) and Orlistat placebo 1 capsule (three times daily). The total dosing period is 2 weeks. Treatment period: The total dosing period is 12 weeks. * Sibutramine monotherapy group: Sibutramine 1 capsule once daily + Orlistat placebo 1 capsule three times daily * Orlistat and Sibutramine combination group: Sibutramine 1 capsule once daily + Orlistat 1 capsule three times daily

Sibutramine + Orlistat; Sibutramine + Orlistat(Placebo)

Orlistat DRUG

○ Dosing standard Run-in period: All subjects would administer Sibutramine placebo 1 capsule (once daily) and Orlistat placebo 1 capsule (three times daily). The total dosing period is 2 weeks. Treatment period: The total dosing period is 12 weeks. * Sibutramine monotherapy group: Sibutramine 1 capsule once daily + Orlistat placebo 1 capsule three times daily * Orlistat and Sibutramine combination group: Sibutramine 1 capsule once daily + Orlistat 1 capsule three times daily

Sibutramine + Orlistat; Sibutramine + Orlistat(Placebo)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• A patient who gave one's voluntary written consent to participate in this clinical study
• Aged ≥ 18 and \< 50 years old
• An obese patient with a body mass index (BMI) ≥ 27 kg/m2
• In case of a women, premenopausal woman

You may not qualify if:

• A patient with the weight change ≥ 5% over the past 3 months
• A patient who was receiving a MAO(monoamine oxldase) inhibitor within 1 months of screening
• A patient with an active acute or chronic disease at the participation of the study
• A patient with the malignancy history within the past 5 years
• A patient diagnosed with secondary obesity (Cushing's syndrome, thyroid disease, etc.)
• A patient with a significant cardiovascular disease (coronary vascular disease, congestive heart failure, peripheral arterial obstructive disease, arrhythmia, cerebrovascular disease, etc.), poorly controlled hypertension defined by JNC(Joint National Committee) 7 guidelines, diabetes, severe hepatic/renal disease and CNS(Central Nervous System) disease, drug abuse, psychiatric disorder, positive prostatic hyperplasia concurrent with urinary retention and glaucoma within the past 1 year according to medical records
• A patient falling under the followings from screening test results Hemoglobin \< 10g/L or platelets \< 100\* 103/μL Total bilirubin \> 2.0mg/dL Serum GOT(Glutamate oxaloacetate transaminase) or GPT(glutamic pyruvate transaminase) \> 120 IU/L Serum creatinine \> 1.4mg/dL Serum uric acid \> 10mg/dL Thyroid stimulating hormone \< 0.1μIU/mL or \> 6.5 μIU/mL
• A patient with clear unexplained abnormal findings in chest X-ray, urinalysis, electrocardiogram
• A pregnant women or breastfeeding mother
• A patient participating in another clinical study other than this study
• Other patient who is legally and mentally not appropriate to participate in a clinical study, at the judgment of the investigator
• A person who participated in other clinical study within the past 3 months

Sponsors & Collaborators

• Gachon University Gil Medical Center: lead

Study Sites (1)

GachonGill Medical Center

Inchon, Namdong-gu, South Korea

Location

Related Publications (4)

• Ko KD, Kim KK, Suh HS, Hwang IC. Associations between the GNB3 C825T polymorphism and obesity-related metabolic risk factors in Korean obese women. J Endocrinol Invest. 2014 Nov;37(11):1117-20. doi: 10.1007/s40618-014-0182-6. Epub 2014 Oct 4.

  PMID: 25280441 DERIVED

• Kim KK, Suh HS, Hwang IC, Ko KD. Influence of eating behaviors on short-term weight loss by orlistat and anorectic agent. Eat Behav. 2014 Jan;15(1):87-90. doi: 10.1016/j.eatbeh.2013.10.019. Epub 2013 Oct 31.

  PMID: 24411757 DERIVED

• Hwang IC, Park JY, Ahn HY, Kim KK, Suh HS, Ko KD, Kim KA. Effects of CYP3A5, CYP2C19, and CYP2B6 on the clinical efficacy and adverse outcomes of sibutramine therapy: a crucial role for the CYP2B6*6 allele. Clin Chim Acta. 2014 Jan 20;428:77-81. doi: 10.1016/j.cca.2013.11.007. Epub 2013 Nov 19.

  PMID: 24262967 DERIVED

• Hwang IC, Kim KK, Ahn HY, Suh HS, Oh SW. Effect of the G-protein beta3 subunit 825T allele on the change of body adiposity in obese female. Diabetes Obes Metab. 2013 Mar;15(3):284-6. doi: 10.1111/dom.12023. Epub 2012 Nov 8.

  PMID: 23061407 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

sibutramine; Orlistat

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals

Study Officials

• Kim Kyoungkon

  GachonGill Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 16, 2010
• First Posted: August 19, 2010
• Study Start: February 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: August 19, 2010

Record last verified: 2009-10

Locations

KR (1)