The Effect of Betahistine on Body Weight in Obese Subjects

NCT00409305 | Completed Phase 2

• 1 other identifier: BET201
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 19

Brief Summary

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

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• To examine the effect of betahistine on body weight in obese subjects

Interventions

Betahistine DRUG

Dietary counseling BEHAVIORAL

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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;

Sponsors & Collaborators

• OBEcure Ltd.: lead

Study Sites (19)

Cahaba Research, Inc.

Birmingham, Alabama, 35242, United States

Location

Scripps Clinic, Nutrition Metabolic Research

San Diego, California, 92130, United States

Location

Diablo Clinical Research, Inc.

Walnut Creek, California, 94598, United States

Location

Miami Research Associates, Inc., Nutrition Division

Miami, Florida, 33143, United States

Location

CSRA Partners in Health, Inc.

Augusta, Georgia, 30909, United States

Location

Radiant Research, Inc.

Chicago, Illinois, 60610, United States

Location

NCCR

Chicago, Illinois, 60611, United States

Location

American Health Network

Indianapolis, Indiana, 46254, United States

Location

Midwest Institute for Clinical Research

Indianapolis, Indiana, 46260, United States

Location

Radiant Research, Inc.

Overland Park, Kansas, 66215, United States

Location

L-MARC Research Center

Louisville, Kentucky, 40213, United States

Location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Radiant Research, Inc.

Edina, Minnesota, 55435, United States

Location

Diabetes & Endocrinology Specialists

Chesterfield, Missouri, 63017, United States

Location

Comprehensive Weight Control Program

New York, New York, 10021, United States

Location

Rochester Clinical Research, Inc.

Rochester, New York, 14609, United States

Location

Lindner Clinical Trial Center

Cincinnati, Ohio, 45219, United States

Location

Covance CRU, Inc.

Portland, Oregon, 97239, United States

Location

Diabetes & Glandular Disease Research Associates, Inc.

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Betahistine; Nutrition Assessment

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Andrew Ahmann, MD

  Covance CRU, Inc

  PRINCIPAL INVESTIGATOR

• Louis Aronne, MD

  Comprehensive Weight Control Program

  PRINCIPAL INVESTIGATOR

• Harold Bays, MD

  L-Marc Research Center

  PRINCIPAL INVESTIGATOR

• Norman Fishman, MD

  Diabetes & Endocrinology Specialists

  PRINCIPAL INVESTIGATOR

• Ken Fujioka, MD

  Scripps Clinic, Nutrition Metabolic Research

  PRINCIPAL INVESTIGATOR

• Jeffrey Geohas, MD

  Radiant Research, Inc

  STUDY DIRECTOR

• Frank Greenway, MD

  Pennington Biodmedical Research Center

  PRINCIPAL INVESTIGATOR

• Dean Kereiakes, MD

  Lindner Clinical Trial Center

  PRINCIPAL INVESTIGATOR

• Diane Krieger, MD

  Miami Research Associates, Nutrition Division

  PRINCIPAL INVESTIGATOR

• Robert Kushner, MD

  NCCR

  PRINCIPAL INVESTIGATOR

• Thomas Moretto, MD

  American Health Network

  PRINCIPAL INVESTIGATOR

• Monica Pierson, MD

  Radiant Research

  PRINCIPAL INVESTIGATOR

• Sherwyn Schwartz, MD

  Diabetes & Glandular Disease Research Associates

  PRINCIPAL INVESTIGATOR

• Diane Smith, MD

  CSRA Partners in Health

  PRINCIPAL INVESTIGATOR

• Philip Toth, MD

  Midwest Institute for Clinical Research

  PRINCIPAL INVESTIGATOR

• Mervyn Weerasinghe, MD

  Rochester Clinical Research

  PRINCIPAL INVESTIGATOR

• Richard Weinstein, MD

  Diablo Clinical Research

  PRINCIPAL INVESTIGATOR

• Lisa Wright, MD

  Cahaba Research, Inc

  PRINCIPAL INVESTIGATOR

• James Zavoral, MD

  Radiant Research, Inc.

  PRINCIPAL INVESTIGATOR

• Nir Barak, MD

  OBEcure Ltd.

  STUDY DIRECTOR

• Yaffa Beck, PhD

  OBEcure Ltd.

  STUDY CHAIR

• Ami Eyal, MD

  OBEcure Ltd.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 6, 2006
• First Posted: December 8, 2006
• Study Start: January 1, 2007
• Study Completion: June 1, 2007
• Last Updated: April 21, 2015

Record last verified: 2007-08

Locations

US (19)