ObesityPhase 2NCT00409305
The Effect of Betahistine on Body Weight in Obese Subjects
A Phase 2 study testing Betahistine and Dietary counseling in people with Obesity, run by OBEcure Ltd. at 19 sites in United States.
Trial summary
The purpose of this study is to examine the effect that betahistine has on body weight in obese subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Betahistine and Dietary counseling
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 280 participants
- Where
- 19 sitesUnited States
- Study dates
- Jan 2007to Jun 2007
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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 >4 kg in the 90 days prior to screening;
Show all 60Show fewer
- 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.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
CSRA Partners in Health, Inc.
Augusta, Georgia, 30909
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
Cahaba Research, Inc.
Birmingham, Alabama, 35242
Diabetes & Endocrinology Specialists
Chesterfield, Missouri, 63017
Radiant Research, Inc.
Chicago, Illinois, 60610
NCCR
Chicago, Illinois, 60611
Lindner Clinical Trial Center
Cincinnati, Ohio, 45219
Radiant Research, Inc.
Edina, Minnesota, 55435
American Health Network
Indianapolis, Indiana, 46254
Midwest Institute for Clinical Research
Indianapolis, Indiana, 46260
L-MARC Research Center
Louisville, Kentucky, 40213
Miami Research Associates, Inc., Nutrition Division
Miami, Florida, 33143
Comprehensive Weight Control Program
New York, New York, 10021
Radiant Research, Inc.
Overland Park, Kansas, 66215
Covance CRU, Inc.
Portland, Oregon, 97239
Rochester Clinical Research, Inc.
Rochester, New York, 14609
Diabetes & Glandular Disease Research Associates, Inc.
San Antonio, Texas, 78229
Scripps Clinic, Nutrition Metabolic Research
San Diego, California, 92130
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Examine the Effect of Betahistine on Body Weight in Obese Subjects
The purpose of this study is to examine the effect that betahistine has on body weight in obese subjects.
- Conditions
- Obesity
- Being tested
- Betahistine, Dietary counseling
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BetahistineDrug
Dietary counselingBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
To examine the effect of betahistine on body weight in obese subjects
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2006 (estimated)
- Study startJan 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single group
- Masking
- Double blind
- Enrolment
- 280 participants
Sponsor and investigators
- Lead sponsor
- OBEcure Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Andrew Ahmann, MD, Principal investigator, Covance CRU, IncLouis Aronne, MD, Principal investigator, Comprehensive Weight Control ProgramHarold Bays, MD, Principal investigator, L-Marc Research CenterNorman Fishman, MD, Principal investigator, Diabetes & Endocrinology SpecialistsKen Fujioka, MD, Principal investigator, Scripps Clinic, Nutrition Metabolic ResearchJeffrey Geohas, MD, Study director, Radiant Research, IncFrank Greenway, MD, Principal investigator, Pennington Biodmedical Research CenterDean Kereiakes, MD, Principal investigator, Lindner Clinical Trial Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00409305
- Sponsor's protocol ID
- BET201
- Status last verified
- Aug 2007
- First submitted
- 6 Dec 2006
- Last updated
- 21 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Examine the Effect of Betahistine on Body Weight in Obese Subjects
- ClinicalTrials.gov ID
- NCT00409305
- Acronym / sponsor ID
- BET201
- Conditions
- Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants
- Lead sponsor
- OBEcure Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2007
- Study completion
- Jun 2007 (actual)
- First posted
- 8 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the effect that betahistine has on body weight in obese subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (60 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Betahistine | Drug | – |
| Dietary counseling | Behavioural | – |
Primary outcome
To examine the effect of betahistine on body weight in obese subjects
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Ahmann, MD principal investigator
Covance CRU, Inc
Louis Aronne, MD principal investigator
Comprehensive Weight Control Program
Harold Bays, MD principal investigator
L-Marc Research Center
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Betahistine and Dietary counseling in people with Obesity, run by OBEcure Ltd. at 19 sites in United States.
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 5 inclusion and 60 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 21 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. 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. 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?
To examine the effect of betahistine on body weight in obese subjects. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Apr 2015.