The Effect of Betahistine on Body Weight in Obese Subjects

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

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Examine the Effect of Betahistine on Body Weight in Obese Subjects

Conditions
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Obesity

Intervention / Treatment
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* Drug: Betahistine
* Behavioral: Dietary counseling


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Betahistine|nan|
|Behavioral: Dietary counseling|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To examine the effect of betahistine on body weight in obese subjects |  |  |