Efficacy Study of Betahistine on Body Weight in Obese Female Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00748436
Recruitment Status : Completed
First Posted : September 8, 2008
Last Update Posted : May 7, 2009
International Antiviral Therapy Evaluation Center
Information provided by:
OBEcure Ltd.

Brief Summary:
The purpose of this study is to examine the effect of betahistine on body weight in obese female subjects

Condition or disease Intervention/treatment Phase
Obesity Drug: betahistine dihydrochloride Drug: placebo Phase 2

Detailed Description:

This is a randomized, double-blind, placebo-controlled, dose finding, multicenter study. The study will consist of 3 treatment groups (48 mg/day, 96 mg/day, and matching placebo). Approximately 180 subjects (60 per treatment group) will be randomized into this 12-week study.

A screening visit will be used to determine subject suitability for inclusion in the trial.

One week after the screening visit subjects who meet all inclusion criteria and none of the exclusion criteria will be randomly assigned to 1 of the following treatment groups:

  • Betahistine 24 mg twice a day (BID) (48 mg/day total),
  • Betahistine 48 mg BID (96 mg/day total),
  • Matching placebo.

All subjects will be prescribed a nutritionally balanced mildly hypocaloric diet. The prescribed diet will contain approximately 30% of calories from fat, 50% of calories from carbohydrates, and 20% of calories from protein. The individual subject's estimated total daily energy expenditure minus 600 kcal will be used to determine each subject's daily caloric intake value during the study. The total daily energy expenditure will be estimated for each subject from the basal energy expenditure multiplied by a correction factor of 1.3 to account for the amount of energy needed in mild to moderate daily activity for obese subjects.

Double-blind treatment will continue for 12 weeks. Study medication (betahistine and/or matching placebo) will be orally administered BID about 1-2 hrs prior to meals (at 10:00 and at 17:00). During this period, 4 additional study visits (at 2, 4, 8, and 12 weeks) will take place.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 187 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Examine the Effect of Betahistine on Body Weight in Obese Female Subjects
Study Start Date : September 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: A
Matching placebo twice a day
Drug: placebo
(placebo tablet + placebo tablet) BID per os 12 weeks
Experimental: B
Betahistine 24 mg twice a day (48 mg/day total)
Drug: betahistine dihydrochloride
(24mg tablet Betahistine + placebo tablet) BID per os 12 weeks
Other Name: Betahistine
Experimental: C
Betahistine 48 mg twice a day (96 mg/day total)
Drug: betahistine dihydrochloride
(24mg tablet Betahistine + 24mg tablet Betahistine) BID per os 12 weeks
Other Name: Betahistine

Primary Outcome Measures :
  1. change in body weight in Kg or % of initial body weight and/or proportion of subjects achieving > 2.5% and/or >5.0 % weight loss. [ Time Frame: From baseline to week 12 ]

Secondary Outcome Measures :
  1. Change in obesity associated conditions [ Time Frame: from baseline to Week 12 ]
  2. Safety parameters [ Time Frame: From baseline to week 12 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Signed written informed consent
  • Female subjects 18 to 50 years of age
  • Pre-menopause
  • Obese with a BMI between 30 kg/m2 and 40 kg/m2
  • Has been obese for at least one year prior to screening
  • Non-lactating
  • Non-pregnant; has a negative urine pregnancy test result, does not plan on becoming pregnant during the study 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 more than 4 kg in the 90 days prior to screening;
  • Has taken drugs capable of influencing body weight 30 days prior to screening;
  • Has recently (<6 months prior screening) 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;
  • 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;
    • Type 1 diabetes mellitus;
    • Type 2 diabetes mellitus on treatment other than metformin monotherapy and/or diet with HbA1c >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 equal or higher than 1.5 mg/dL (133 µmol/L) at screening;
    • Malignant disease within 5 years of screening;
    • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) higher than 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] >400 mg/dL or low-density lipoprotein cholesterol [LDL-C] >190 mg/dL), or uncontrolled diabetes (HbA1c >8%);
  • History of asthma;
  • History of peptic ulcers associated with gastrointestinal bleeding or that required treatment with H2 blockers or proton pump inhibitors in the last 12 months.
  • Has undergone bilateral Ovarectomy.
  • History of HIV
  • 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 psychiatric or neurological disorders requiring chronic medications (e.g., antidepressants) and/or subjects score of > 8 on The Harvard Department of Psychiatry and National Depression Screening Day Scale (THE HANDS) (meaning " Presence of a major depressive episode is likely.").
  • 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:

    • 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, rimonabant and phentermine;
      • Over-the-counter antiobesity agents (e.g., herbal supplements or other alternative remedies);
    • Psychotropic/neurological agents including the following:

      • Antipsychotic agents (e.g., olanzapine, clozapine, risperidol, lithium, etc.).
      • Antiepileptic agents (e.g., topiramate , zonisimide, valproate, carbamazepine);
      • Antidepressant agents including the following: monoamine oxidase inhibitors, bupropion, tricyclic antidepressants, and tetracyclic antidepressants; and selective serotonin reuptake inhibitors (e.g., Fluoxetine, bupropion);
    • Systemic steroids administered by oral, intravenous, or intramuscular route;
    • Drugs that directly affect gastrointestinal motility (e.g., metoclopramide, and chronic [taken for more than 10 days within a 6- month period] macrolide antibiotics such as erythromycin and newer derivatives);
    • Calcitonin;
    • Insulin;
    • Exenatide;
    • Sulfonylureas;
    • Meglitinides
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00748436

GP: Dr. Van Mulders
Aalst, Belgium, 9310
UZ Antwerpen
Edegem, Belgium, 2650
UZ Gent
Gent, Belgium, 9000
UZ Leuven
Leuven, Belgium, 3000
Zentrum für Therapiestudien
Leipzig, Germany, 04103
CRS Clinical Research Services
Mönchengladbach, Germany, 41061
Emotional Brain
Almere, Netherlands, 1311
GP: Dr. Rol
Bennebroek, Netherlands, 2121
Den Haag, Netherlands, 2582
Etten-leur, Netherlands, 4873
Geleen, Netherlands, 6166
Rotterdam, Netherlands, 3081
Sponsors and Collaborators
OBEcure Ltd.
International Antiviral Therapy Evaluation Center
Study Director: Yaffa Beck, PhD, CEO OBEcure Ltd.
Principal Investigator: Luc Van Gaal, MD Professor UZ Antwerpen
Study Chair: Nir Barak, MD OBEcure Ltd.

Responsible Party: Yaffa Beck, CEO, OBEcure Ltd. Identifier: NCT00748436     History of Changes
Other Study ID Numbers: BET207
First Posted: September 8, 2008    Key Record Dates
Last Update Posted: May 7, 2009
Last Verified: May 2009

Keywords provided by OBEcure Ltd.:
Obese females
Weight loss

Additional relevant MeSH terms:
Body Weight
Signs and Symptoms
Vasodilator Agents
Histamine Agonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs