the effect of betahistine on body weight in obese subjects

Conditions: Obesity

Summary: the purpose of this study is to examine the effect that betahistine has on body weight in obese subjects.


Eligibility criteria:
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.