The Effect of Betahistine on Body Weight in Obese Subjects
Phase 2
Completed
- Conditions
- Obesity
- Registration Number
- NCT00409305
- Lead Sponsor
- OBEcure Ltd.
- Brief Summary
The purpose of this study is to examine the effect that betahistine has on body weight in obese subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 280
Inclusion Criteria
- Signed written informed consent;
- Male or female subjects 18 to 65 years of age;
- Is obese with a BMI greater than or equal to 30 kg/m2 to less than or equal to 40 kg/m2;
- Has been obese for at least 1 year prior to screening; and
- If female, is nonlactating, has a negative urine pregnancy test result, and does not plan on becoming pregnant during the study, or not of childbearing potential (hysterectomy or tubal ligation at least 6 months prior to randomization or post-menopausal for 1 year); if of childbearing potential (including peri-menopausal women who have had a menstrual period within 1 year) must practice or be willing to continue to practice appropriate birth control (such as implants, injectables, oral contraceptives, some intrauterine contraceptive devices, sexual abstinence, tubal ligation, or a vasectomized partner) during the entire study duration.
Exclusion Criteria
- Has obesity of known endocrine origin (e.g., Cushing's disease, Addison's disease, hypothalamic tumor);
- Has a medical history (e.g., morbid childhood obesity) and/or physical characteristics (e.g., polydactyly) suggestive of genetic obesity (e.g., ob/ob genotype) or syndromatic obesity (e.g., Prader-Willi syndrome, Bardet Biedl syndrome);
- Previous surgical procedures for weight loss;
- Has had liposuction within 1 year before screening or is planning to have liposuction during the study;
- History of bulimia or evidence of laxative abuse;
- Has had a body weight loss of >4 kg in the 90 days prior to screening;
- Has taken drugs capable of influencing body weight 30 days prior to screening;
- Has recently started or plans on starting a smoking cessation program;
- Has had a major change in daily physical activity (e.g., initiation of an exercise program) or started a weight loss program within 90 days prior to screening;
- Is unwilling or unable to participate in a dietary program as part of the study;
- Is <80% compliant with study medication in the single-blind placebo run-in period;
- Has a clinically significant history or presence of any of the following conditions:
- Active or past history of cardiovascular or cerebrovascular disease including unstable angina, myocardial infarction, transient ischemic attacks/stroke, clinically significant arrhythmia, congestive heart failure, or cardiac valve abnormalities;
- Liver disease (irrespective of transaminase concentrations);
- Pheochromocytoma;
- Porphyria;
- Type 1 diabetes mellitus;
- Type 2 diabetes mellitus on treatment other than metformin monotherapy and/or diet with HbA1c less than or equal to 8%;
- Severe type 2 diabetes with history of ketoacidosis or diabetic ulcers, or presence of retinopathy, neuropathy, or nephropathy;
- Renal insufficiency defined as a serum creatinine greater than or equal to 1.5 mg/dL (133 µmol/L) at screening;
- Malignant disease within 5 years of screening;
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2 x ULN;
- Thyroid-stimulating hormone (TSH) outside of the normal range;
- Plans on having any surgery (elective or otherwise) during the course of the study;
- Has uncontrolled hypertension (sitting blood pressure >160/95 mmHg at screening or randomization), uncontrolled hyperlipidemia (triglycerides [TG] greater than or equal to 400 mg/dL or low-density lipoprotein cholesterol [LDL-C] >160 mg/dL), or uncontrolled diabetes (HbA1c >8%);
- History of asthma;
- History of peptic ulcers;
- History of HIV;
- History of undiagnosed allergy, severe allergy, or drug allergy, including history of anaphylaxis, angioedema, bronchospasm, or urticaria;
- Has clinical laboratory test values (chemistry, hematology, or urinalysis) judged to be clinically significant by the investigator;
- Has a physical examination or electrocardiogram (ECG) with significant abnormalities, as judged by the investigator;
- Currently abuses drugs or alcohol or has a history of abuse that in the investigator's opinion could cause the subject to be noncompliant with study procedures;
- Has hypersensitivity to betahistine;
- Has psychiatric or neurological disorders requiring chronic medications (e.g., antidepressants), subjects are to be unlikely to have a major depressive episode (score of lees than or equal to 8) on The Harvard Department of Psychiatry and National Depression Screening Day Scale (THE HANDS) (See Appendix E);
- Chronic or as needed use of antihistamines;
- Has not been on a stable treatment regimen with any of the following medications for a minimum of 90 days prior to screening:
- Hormone replacement therapy;
- Oral contraceptives;
- Antihypertensive agents;
- Metformin;
- Lipid-lowering agents; or
- Thyroid replacement therapy;
- Has been treated over the past 60 days, is currently treated, or is expected to require or undergo treatment with any of the following excluded medications;
- All prescription or over-the-counter agents taken for the purpose of weight reduction, including (but not limited to) the following anti obesity agents:
- Prescription drugs such as orlistat, sibutramine, and phentermine; or
- Over-the-counter antiobesity agents (e.g., herbal supplements or other alternative remedies such as Cortislim, Dexatrim, Acutrim);
- Psychotropic/neurological agents including the following:
- Antipsychotic agents (e.g., olanzapine, clozapine, risperidol, lithium, etc.).
- Antiepileptic agents (e.g., Topamax®, Zonegran®, valproate, carbamazepine); or
- Antidepressant agents including the following: monoamine oxidase inhibitors, bupropion (Wellbutrin®, Zyban®), tricyclic antidepressants, and tetracyclic antidepressants; and selective serotonin reuptake inhibitors (e.g., Prozac®, Paxil®, Zoloft®, etc.);
- Systemic steroids administered by oral, intravenous, or intramuscular route;
- Drugs that directly affect gastrointestinal motility (e.g., Reglan® and Propulsid®, and chronic [taken for more than 10 days within a 6-month period] macrolide antibiotics such as erythromycin and newer derivatives);
- Calcitonin (e.g., Miacalcin®);
- Insulin;
- Exenatide (Byetta);
- Sulfonylureas (e.g., Diamicron, Amaryl, Glucotrol, Micronase); or Meglitinides (e.g., Starlix, Prandin)
- Has received any investigational drug within 90 days of screening;
- Receipt of any investigational treatment (drug or device) within 90 days prior to screening;
- Is an immediate family member of personnel directly affiliated with the study at the investigative site, or is personally directly affiliated with the study at the investigative site; or
- Is employed by OBEcure Ltd.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To examine the effect of betahistine on body weight in obese subjects
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (17)
Scripps Clinic, Nutrition Metabolic Research
🇺🇸San Diego, California, United States
Rochester Clinical Research, Inc.
🇺🇸Rochester, New York, United States
Pennington Biomedical Research Center
🇺🇸Baton Rouge, Louisiana, United States
American Health Network
🇺🇸Indianapolis, Indiana, United States
L-MARC Research Center
🇺🇸Louisville, Kentucky, United States
CSRA Partners in Health, Inc.
🇺🇸Augusta, Georgia, United States
Comprehensive Weight Control Program
🇺🇸New York, New York, United States
Radiant Research, Inc.
🇺🇸Edina, Minnesota, United States
Diabetes & Endocrinology Specialists
🇺🇸Chesterfield, Missouri, United States
Cahaba Research, Inc.
🇺🇸Birmingham, Alabama, United States
Diablo Clinical Research, Inc.
🇺🇸Walnut Creek, California, United States
Miami Research Associates, Inc., Nutrition Division
🇺🇸Miami, Florida, United States
NCCR
🇺🇸Chicago, Illinois, United States
Midwest Institute for Clinical Research
🇺🇸Indianapolis, Indiana, United States
Covance CRU, Inc.
🇺🇸Portland, Oregon, United States
Diabetes & Glandular Disease Research Associates, Inc.
🇺🇸San Antonio, Texas, United States
Lindner Clinical Trial Center
🇺🇸Cincinnati, Ohio, United States