Overview

The Effect of Betahistine on Body Weight in Obese Subjects

Status:
Completed
Trial end date:
2007-06-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to examine the effect that betahistine has on body weight in obese subjects.
Phase:
Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
OBEcure Ltd.
Treatments:
Betahistine
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.