The Effect of Betahistine on Body Weight in Obese Subjects

Completed · Phase 2

Conditions studied: Obesity

In brief

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

Key facts

Study ID

NCT00409305

Run by

OBEcure Ltd.

People needed

280

Starts

2007-01-01

Expected to finish

2007-06-01

Last updated by the study team

2015-04-21

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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%);

Where it is running

• Cahaba Research, Inc. — Birmingham, Alabama, United States
• Scripps Clinic, Nutrition Metabolic Research — San Diego, California, United States
• Diablo Clinical Research, Inc. — Walnut Creek, California, United States
• Miami Research Associates, Inc., Nutrition Division — Miami, Florida, United States
• CSRA Partners in Health, Inc. — Augusta, Georgia, United States
• Radiant Research, Inc. — Chicago, Illinois, United States
• NCCR — Chicago, Illinois, United States
• American Health Network — Indianapolis, Indiana, United States
• Midwest Institute for Clinical Research — Indianapolis, Indiana, United States
• Radiant Research, Inc. — Overland Park, Kansas, United States
• L-MARC Research Center — Louisville, Kentucky, United States
• Pennington Biomedical Research Center — Baton Rouge, Louisiana, United States
• Radiant Research, Inc. — Edina, Minnesota, United States
• Diabetes & Endocrinology Specialists — Chesterfield, Missouri, United States
• Comprehensive Weight Control Program — New York, New York, United States
• Rochester Clinical Research, Inc. — Rochester, New York, United States
• Lindner Clinical Trial Center — Cincinnati, Ohio, United States
• Covance CRU, Inc. — Portland, Oregon, United States
• Diabetes & Glandular Disease Research Associates, Inc. — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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