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ObesityPhase 2NCT00748436

Efficacy Study of Betahistine on Body Weight in Obese Female Subjects

A Phase 2 study testing betahistine dihydrochloride in people with Obesity, run by OBEcure Ltd. at 12 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to examine the effect of betahistine on body weight in obese female subjects Read more about this study

Who is it for?
Ages 18 to 50 years, women only
Conditions the study is for
Obesity
What is being tested?
betahistine dihydrochloride
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
187 participants
Where
12 sitesin 3 countries
Study dates
Sep 2008to Apr 2009
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

12 sites in 3 countries.

12 sites in 3 countries

Netherlands6 sites

  • Emotional Brain

    Almere Stad, 1311

  • GP: Dr. Rol

    Bennebroek, 2121

  • Wecor

    Etten-Leur, 4873

  • PT&R

    Geleen, 6166

  • AMWO

    Rotterdam, 3081

  • AMWO

    The Hague, 2582

Other trials in Netherlands

Belgium4 sites

  • GP: Dr. Van Mulders

    Aalst, 9310

  • UZ Antwerpen

    Edegem, 2650

  • UZ Gent

    Ghent, 9000

  • UZ Leuven

    Leuven, 3000

Other trials in Belgium

Germany2 sites

  • Zentrum für Therapiestudien

    Leipzig, 04103

  • CRS Clinical Research Services

    Mönchengladbach, 41061

Other trials in Germany

About this study

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

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

Read the 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.

Conditions
Obesity
Being tested
betahistine dihydrochloride, placebo
Keywords
Obese females, Weight loss, Betahistine
Medical subject headings
Obesity, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • betahistine dihydrochlorideDrug

    Also called Betahistine

    (24mg tablet Betahistine + placebo tablet) BID per os 12 weeks

  • betahistine dihydrochlorideDrug

    Also called Betahistine

    (24mg tablet Betahistine + 24mg tablet Betahistine) BID per os 12 weeks

  • placeboDrug

    (placebo tablet + placebo tablet) BID per os 12 weeks

Study groups in NCT00748436
Study groupRoleWhat they receive
APlacebo comparatorMatching placebo twice a day
Receives: Drug: placebo
BExperimentalBetahistine 24 mg twice a day (48 mg/day total)
Receives: Drug: betahistine dihydrochloride
CExperimentalBetahistine 48 mg twice a day (96 mg/day total)
Receives: Drug: betahistine dihydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From baseline to week 12

Secondary outcomes (2)

  1. Change in obesity associated conditions

    Measured: from baseline to Week 12

  2. Safety parameters

    Measured: From baseline to week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2008 (estimated)
  2. Study startSep 2008
  3. Primary completionApr 2009
  4. Study completionApr 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
187 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00748436
Sponsor's protocol ID
BET207
Other IDs
2008-001840-38, S51130, ML5059, 2008
Status last verified
May 2009
First submitted
5 Sep 2008
Last updated
7 May 2009
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing betahistine dihydrochloride in people with Obesity, run by OBEcure Ltd. at 12 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 54 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 May 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Netherlands, Belgium, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00748436.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2009.

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